Albrecht Elbo-track L/L User manual

USER INSTRUCTIONS
ELBO-TRACK
HINGED ELBOW BRACE
WITH EXTENSION AND FLEXION LIMITATION
OPTIONALLY WITH ADJUSTABLE HANDLE

Contents
1. Introduction.................................................................................................. 4
1.1. Foreword ..................................................................................................... 4
1.2. Customer information .................................................................................. 4
1.3. Mode of operation ....................................................................................... 4
1.4. Application .................................................................................................. 4
1.5. Scope of delivery.......................................................................................... 4
1.6. Declaration of conformity............................................................................. 4
1.7. Features ....................................................................................................... 5
1.8. Indications................................................................................................... 5
1.9. Contraindications......................................................................................... 5
1.10. Safety Instructions...................................................................................... 6
1.11. Warranty .................................................................................................... 6
2. Adjustments by the orthopaedic technician......................................... 7
2.1. Fitting on the patient.................................................................................... 7
2.1.1. Adjusting the brace to the arm shape by using an
orthopaedic "bending iron" .......................................................................... 7
2.1.2. Adjusting the brace components ......................................................... 8
2.1.3. Assembling and adjusting the adjustable handle ................................ 9
2.2. Hinge adjustments..................................................................................... 10
2.2.1. Opening the hinge cover.................................................................... 10
2.2.2. Setting extension, e.g. to 30°............................................................ 11
2.2.4. Immobilizing the brace, e.g. at 30° ................................................... 12
2.2.5. Securing the stop pins ....................................................................... 12
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2.3. Setting the hinge for Elbo-track Bambini..................................................... 13
2.3.1. Remove the hinge cover..................................................................... 13
2.3.2. Setting the extension limitation ........................................................ 14
2.3.3. Setting the flexion limitation............................................................. 14
2.3.4. Immobilisation................................................................................... 15
2.3.5. Reattach the hinge cover .................................................................. 15
2.4. Attaching of the brace by the orthopaedic technician.................................. 16
2.4.1. Placing the brace on the arm ............................................................. 16
2.4.2. Setting the strap lengths and adjusting them as necessary ............. 17
2.4.3. Final adjustment................................................................................ 17
3. Handling by the patient........................................................................... 18
3.1. Taking off the brace.................................................................................... 18
3.2. Putting on the brace .................................................................................. 19
4. Cleaning, maintenance and disinfection ............................................. 20
4.1. Care........................................................................................................... 20
5. Technical data / materials........................................................................ 21
6. Table of sizes and article numbers........................................................ 21
7. Transfer of the brace................................................................................. 22
8. Disposal ....................................................................................................... 22
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User Instructions

1. Introduction
1.1. Foreword
Functional braces are used to relieve and
stabilize the joints and tendons following
injury and surgery. Their function is to protect
joints and tendons during rehabilitation and
prevent them from becoming stiff.
Our braces ensure protection and guidance
during the healing process and allow gradual
controlled return to full physiological mobility.
1.2. Customer information
For your own safety please read through these
User Instructions carefully and accurately
before using the brace. The instructions, notes
and procedures must be read and understood
thoroughly in order to benefit from the correct
operation and use of the device. If anything
in the User Instructions is not clear, or any
instructions, operating procedures or safety
information is not fully understandable, please
contact the appropriate specialist retailer or
albrecht GmbH directly, before you use the
brace. This particularly applies to the safety
instructions.
1.3. Mode of operation
The Elbo-track elbow brace stabilizes and
relieves the joint and tendons after tendon
injury during conservative and postoperative
rehabilitation. The shell and strap construction
allows comfortable individual fitting, helping
to make the splint very comfortable to wear.
1.4. Application
The brace must only be used for the orthotic
treatment of the elbow.
1.5. Scope of delivery
The Elbo-track is delivered to you ready to use
in the size requested, with User Instructions
and labeling on the product.
Please check the completeness of the brace at
delivery.
• Brace with padding and straps
• User Instructions
1.6. Declaration of conformity
The albrechtGmbH company as manufacturer
with sole responsibility declares the conformity
of the Elbo-track brace with European Council
Directive 93/42/EEC for medical devices.
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1.7. Features
• Anatomically formed hinge rods and shells
• Individually adjustable straps
• Limits can be adjusted without tools
• Easy handling and high wearing comfort
Elbo-track L/L, M/M, S/S and Junior:
• Extension limit can be adjusted in
15°intervals from 0° until 135°
• Flexion limit can be adjusted in
15° intervals from 0° until 120°
• Immobilisation of the brace can be adjusted
in 15° intervals between 0° and 135°
• Assembly of an adjustable handle possible
for sizes L/L and M/M
Elbo-track Bambini:
• Extension limit can be adjusted in
10°intervals from -10° until 100°, to allow
for physiological hyperextension
• Flexion limit can be adjusted in
10° intervals from -10° until 130°
• Immobilisation of the brace can be adjusted
in 10° intervals between -10° and 100°
1.8. Indications
The physician decides on management based
on diagnostic findings.
The treatment is generally indicated for:
• Mild to moderate instability of the elbow
joint
• Post-traumatic and postoperative
immobilization
• Guided movement of the elbow joint
For any other indications, the physician must
be consulted.
1.9. Contraindications
The brace is intended exclusively for contact
with intact skin.
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User Instructions

1.10. Safety Instructions
The optimal effect of the brace is only
achieved when used correctly.
• The brace must only be used in the intact,
complete and mechanically undamaged
condition and with complete and intact
cushioning and walers. This must be verified
by the user before each usage.
• Opening or removing one or more belts,
as well as excessive loosening of the waler
when using the brace leads to a reduction of
the therapeutic effect of the brace and may
lead to injury.
• The brace must not be worn over open
wounds.
• The skin should be free of oils, grease, gels
or other debris, to prevent reactions with the
skin or the structure of the material.
• The orthosis should fit firmly but not
too tight, so as not to restrict the blood
circulation and adversely affect nerve and
lymph vessels. Excessive compression is
therefore to be avoided.
• Combination with other products is currently
not provided for or is to be agreed with the
manufacturer in writing.
• The brace is not intended for single use,
but is intended for multiple use by a single
person.
• The product as delivered is not sterile.
• Contact your physician immediately in the
event of an allergic reaction.
• Please note that cushioned sections can heat
up under direct sunlight. Protect the orthosis
from direct sunlight if necessary.
• Currently there is no test for flammability.
Exercise caution when using the orthosis
in the direct vicinity of open flames such as
lighters and cigarettes.
1.11. Warranty
We assume the warranty for the brace for a
period of 3 months. The brace is a medical
rehabilitation device and must not be used
for any purpose other than the intended, as
described in the Instructions for Use. Changes
to the brace or other applications require the
written consent of the albrechtGmbH. If this
is not obtained, the manufacturer may not
honor the guarantee. If you are using single
joints or other components, these should be
used as intended. If changes or modifications
(e.g. additional mounting holes) are made
to the individual parts or components, the
manufacturer‘s warranty no longer applies.
The removal of or damage to the QM seal will
also void the warranty.
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2. Adjustments by the orthopaedic technician
2.1. Fitting on the patient
• Our braces are adjustable and constructed for fitting to the patient.
• The position of the movable components of the brace can be changed and
they can be shaped.
• The hinge rods can be adjusted by bending them to the contour of the
extremity.
• The strap lengths can be adjusted to different circumferences and shortened
if necessary.
2.1.1. Adjusting the brace to the arm shape by using an
orthopaedic "bending iron"
The brace is anatomically contoured. However, if a different shape is required,
the hinge rods can be adjusted to the shape of the patient’s arm with the aid of
an orthopaedic bending iron.
Loosen the screws on the shell components and either move or remove them.
Then adjust the hinge rods to the shape of the extremity.
bending iron
When adjusting the hinge rods to the shape of the extermity by using
an orthopaedic bending iron, you must not bend the rods in the area
of the hinge housing or the hinge cover as this could lead to damage or
break of the hinge.
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User Instructions

2.1.2. Adjusting the brace components
The brace components are adjustable.
1.Loosen the screws on the brace components using the tool provided.
2.Move the components into the desired position.
3.Tighten the screws again.
The brace components can be adjusted by shaping to the contour.
31 2
32
1
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2.1.3. Assembling and adjusting the adjustable handle
1.By loosening the two fixing screws you can remove the forearm shell from the
hinge rod.
Note: two longer screws are enclosed with the handle.
2.Now place the mounting rod of the handle between the hinge rod and
forearm shell.
3.After aligning the components, insert the longer fixing screws provided into
the threaded holes in the hinge rod.
To adjust the length of the handle to the length of the arm, lift the pad off
the screws to allow the screws to be loosened by one turn. After adjusting
the handle, tighten the screws again.
4.You can adjust the angle of the handle infinitely from 70° pronation to
70° supination by loosening the knurled screw and fixing it in the desired
position.
1 2
3 4
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User Instructions

2.2. Hinge adjustments
2.2.1. Opening the hinge cover
1.Hinge with closed cover.
2.Open the hinge cover by pushing it off the hinge with your fingers.
3.Hinge with the stop pins in neutral position.
In this position there is maximum extension and flexion of the brace.
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2.2.2. Setting extension, e.g. to 30°
4 To set extension, pivot the brace into flexion.
5 
Withdraw the stop pin for extension from the 0 position and insert it in the
desired hole for extension, 30° in this case. The brace is now set to 30°
extension. Maximum flexion is still possible.
54
2.2.3. Setting flexion, e.g. to 60°
6 
To set flexion, pivot the brace in extension, against the already positioned
stop pin for extension.
7 Withdraw the stop pin for flexion from the ∞ position.
8 
Insert the pin into the desired hole for flexion, 60° in this case.
The brace is now set to 60° flexion and 30° extension.
6 7 8
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User Instructions

2.2.4. Immobilizing the brace, e.g. at 30°
9 
To immobilize the brace, in this case at 30°, insert the stop pin for extension
in the 30° hole for extension. Then pivot the brace in extension against the
stop pin for extension. Then insert the stop pin for flexion in the 30° hole for
flexion. The brace is now immobilized at 30°.
9
2.2.5. Securing the stop pins
 
After all adjustments, close the hinge cover and press it against the hinge
until you hear it click into place. The stop pins are now secured against
sliding out accidentally.
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2.3. Setting the hinge for Elbo-track Bambini
Extension and flexion can be limited in 10° steps by appropriate positioning of
the stop pins.
In order to set the Extension/ Flexion limitation and the immobilisation the
follwing steps must be executed.
2.3.1. Remove the hinge cover
1.Rotate the hinge cover 90°.
2.Remove the cover from the hinge.
1 1 2
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User Instructions

2.3.2. Setting the extension limitation
1.In order to set the extension limitation, bring the brace into flexion.
2.Place the stop into the desired position.
1 2 2
2.3.3. Setting the flexion limitation
1.In order to set the flexion limitation, bring the brace into extension.
2.Place the stop into the desired position.
1 2 2
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2.3.4. Immobilisation
In order to immobilize the brace, first set the the extension limtation.
Move the hinge rod against the extension limitation and position the flexion
stop adjacent to the hinge rod.
2.3.5. Reattach the hinge cover
1.Make sure that both stops are placed in the holes.
2.Reattach the cover and rotate it 90° until the locking position. The hinge
cover must always be closed after any adjustment in order to secure the
stops.
1 2
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User Instructions

2.4. Attaching of the brace by the orthopaedic technician
2.4.1. Placing the brace on the arm
1.Place the brace on the patient‘s arm from below.
Ensure that the pivot point of the brace hinge coincides with the physiological elbow pivot
point.
1
It is possible to adjust the arm rods to the patient‘s arm contour by bending them.
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2.4.2. Setting the strap lengths and adjusting them as necessary
Adjust the straps to the desired length and shorten them if necessary.
1.First close the narrow upper arm strap to hold it.
2.Close the forearm strap nearer to the joint.
3.Close the forearm strap further from the joint.
4.Close the wide upper arm strap.
1 2 3 4
2.4.3. Final adjustment
After closing the individual straps, check the strap lengths and check that the
brace is in the right position, correcting this if necessary. Ensure that the straps
are not too tight so as not to interfere with the circulation.
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User Instructions

3. Handling by the patient
3.1. Taking off the brace
1-4Open the strap fasteners
To remove the brace, simply open the clips and do not unthread the straps.
5Remove the brace downwards
Take off the brace.
1
4
2
5
3
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3.2. Putting on the brace
Close the clips in the stated order.
1.Place the brace on your arm from below.
2-5Close the clips in the stated order.
1
4
2
5
3
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User Instructions

h
Hand wash at 30°C
C
Do not bleach
t
Do not iron
k
Do not dry-clean
y
Do not tumble dry
4. Cleaning, maintenance and disinfection
The orthosis is designed to be maintenance-free. To
ensure proper operation over the period of treatment
the orthosis should be cleaned regularly (at least every
3 months) or as required, according to the following
instructions.
4.1. Care
• The product as delivered is not sterile and is not suitable for
sterilization.
• Do not use harsh or abrasive cleaners.
• All fabrics can be washed by hand at 30° C using water and a
mild detergent and / or disinfectant.
• Not machine washable.
• The Elbo-track can be dried in the open air.
• In the case of more severe soiling, a replacement set of textile
parts is available.
• Wipe down surfaces with a cloth soaked with disinfectant.
• Wet completely, and do not wipe off.
• Spray inaccessible surfaces.
• When spraying ensure complete wetting.
• A mild alcohol-based disinfectant is recommended.
Ask your physician or pharmacist when selecting a disinfectant,
and follow the instructions given by the disinfectant
manufacturer. The Robert Koch list of approved disinfectants
can be found at www.rki.de.
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