Albrecht CDS Elbow Brace Extension User manual

USER INSTRUCTIONS
CDS®ELBOW BRACE EXTENSION
ELBOW ORTHOSIS
DYNAMIC SPRING-LOADED ELBOW ORTHOSIS

CDS®Elbow Brace Extension
User Instructions
2
EN
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.................................................................................................. 7
2. Adjustment by the orthopaedic technician ........................................... 8
2.1. Fitting to the patient ................................................................................ 8
2.1.1. Adjusting the brace to the arm shape by using an
orthopaedic "bending iron" ..................................................................... 8
2.1.2. Setting the shell components ........................................................ 9
2.1.3. Assembling and adjusting the adjustable handle for
CDS®Elbow Braces Extension L/L, M/M, S/S and Junior .................... 10
2.2. Setting of the hinge................................................................................11
2.2.1. Adjusting the position of the redression and limitation range for
CDS®Elbow Braces Extension XS/XS and Bambini.............................. 11
2.2.2. Setting the limitation for
CDS®Elbow Braces Extension L/L, M/M, S/S and Junior .................... 12
2.2.3. Fine adjustment for
CDS®Elbow Braces Extension L/L, M/M, S/S and Junior .................... 13
2.2.4. Inserting the stop wedge for
CDS®Elbow Braces Extension L/L, M/M, S/S and Junior .................... 14
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2.3. Application of the brace by the orthopaedic technician .................... 15
2.3.1. Deactivate the spring tension ...................................................... 15
2.3.2. Attaching the brace to the elbow............................................... 16
2.3.3. Adjust strap lengths as necessary .............................................. 17
2.3.4. Final adjustment............................................................................ 17
2.3.5. Activate the spring tension.......................................................... 18
2.3.6. Setting the spring tension to the intensity needed
by the patient............................................................................................ 19
2.3.7. Changing the spring tension ....................................................... 20
3. Handling by the patient ........................................................................... 21
3.1. Removing the brace ............................................................................... 21
3.2. Putting on the brace.............................................................................. 22
4. Cleaning, maintenance and disinfection.............................................. 23
4.1. Care ......................................................................................................... 23
5. Technical data............................................................................................. 24
6. Size chart and article numbers ............................................................... 24
7. Transfer of the brace................................................................................. 25
8. Disposal........................................................................................................ 25
EN
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CDS®Elbow Brace Extension
User Instructions
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1. Introduction
1.1. Foreword
Dynamic spring-loaded orthoses can be used
to treat joint contractures caused by both
neurological and orthopaedic conditions.
The shortening of the tissue surrounding the
joint decreases the range of motion affecting
the patient’s everyday life. Therefore, our
CDS®-concept aims to increase the range of
motion without pain by applying a constant,
appropriate low load prolonged stretch (LLPS).
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 CDS®Elbow Brace Extension functions
according to the CDS®-principle and has been
designed to treat an extension deficit of the
elbow. The brace applies a dynamic low load
prolonged stretch to stimulate growth in the
contracted tissue. The adjustable redression
range protects the tissue from overstretching
and allows for individual extension until -15.
1.4. Application
The brace has been designed exclusively for
the orthotic treatment of the elbow joint and
for contact with intact skin.
1.5. Scope of delivery
The CDS®Elbow Brace Extension 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
• albrechtGmbH hexagon key
• User Instructions
• Strap padding set
1.6. Declaration of conformity
The albrecht GmbH company, as the
manufacturer solely responsible, declares that
the CDS®Elbow Brace Extension conforms
to the Regulation (EU) 2017/745 concerning
medical devices.
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1.7. Features
• Therapy in extension
• Individual adjustment of the spring tension
• Spring tension can be switched on and off
without tools and without varying the set
spring tension
• Optimized shell- and strapsystem:
• High wearing comfort thanks to air-
permeable, light aluminium shell elements
• High flexibility thanks to adjustable shell
elements
CDS®Elbow Brace Extension
L/L, M/M, S/S and Junior:
• Infinitely variable adjustment of the
redression range between -15° and +30°
CDS®Elbow Brace Extension
XS/XS and Bambini:
• Adjustment of the redression range
in 10° steps
1.8. Indications
The physician will prescribe the type of
treatment to apply based on his or her
diagnostic findings.
Generally, the use is indicated in:
• Joint contractures:
– After surgery
– After conservative treatment of capsular
ligament injuries
– Before and after joint replacement
– In arthrosis and chronic polyarthritis
– After burns
– After strokes
– After cranio-cerebral trauma (CCT)
• To prevent new contractures after arthrolysis
• Treatment after biceps tendon rupture
For all other indications a physician must be
consulted.
1.9. Contraindications
• Bony obstruction, osteoporosis
thrombophlebitis
The brace is intended exclusively for contact
with intact skin.
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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.
• The mechanical functions must only be
adjusted using the supplied tools in order to
avoid injuries and damage of the hinge.
• 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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1.11. Warranty
In addition to the legal warranty, we provide
a 6-month durability guarantee for the
orthosis. If properly used, this guarantees
that the orthosis will function without fault.
This excludes the padding and straps, which
are usually liable to a certain amount of
wear and tear. This kind of wear and tear
does not represent a product defect. This
manufacturer’s warranty is subject to the
condition that the orthosis is used as a medical
rehabilitation device and for no other purpose
than that described in the instructions for
use. Changes to the orthosis or the removal /
damage to the quality management seal will
invalidate the warranty.
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2. Adjustment by the orthopaedic technician
2.1. Fitting to the patient
• Our CDS®braces are constructed to be adjustable.
• The position of the shell components can be changed and they can be shaped.
• The hinge rods can be adapted to the shape of the extremity by using an
orthopaedic bending iron.
• The strap lengths can be adjusted to different girths 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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2.1.2. Setting the shell components
The shell components are moveable.
1 Loosen the screws on the shell components with the supplied tool without
unscrewing them completly.
2 Move the shell components into the desired position.
3 Tighten the screws again.
331122
331122
The shell components can be adjusted to the shape of the extremity.

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User Instructions
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2.1.3. Assembling and adjusting the adjustable handle for
CDS®Elbow Braces Extension L/L, M/M, S/S and Junior
1 You can separate the forearm shell from the hinge rod by loosening the two
fixing screws.
2 Now place the handle‘s assembly rod between the hinge rod and forearm
shell.
3 After aligning the components, insert the longer fixing screws supplied with
the handle into the threaded holes in the hinge rod.
To adjust the length of the handle to the length of the arm, loosen the screws
by one turn each. Adjust the handle and tighten the screws again.
4 By loosening the knurled screw, you can adjust the angle of the handle
infinitely from 70° pronation to 70° supination. Fix it in the desired position
and tighten the knurled screw again.
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2.2. Setting of the hinge
2.2.1. Adjusting the position of the redression and limitation range for
CDS®Elbow Braces Extension XS/XS and Bambini
The CDS®Elbow Braces Extension XS/XS and Bambini are constructed on the basis
of the 360° Nano hinge. In the 360° Nano hinge, the position of the spring housing
is adjustable on relation to the upper arm rod. The position of the redression and
limtation range can be thereby altered and adjusted to the patient. The position of the
stops depends on the position of the redression and limitation range.
1 Remove the pad.
2 Loosen the central screw with the
supplied tool until you can remove
the upper arm rod completly from the
gearing.
3 You can adjust the position of the
redression range in 10° steps. By
adjusting the position of the redression
range, you can set flexion and extension
limitation. Use a gonimometer to
determine the desired position and
adjust the hinge accordingly.
4 Place the the upper arm rod on the
gearing and thighten the central screw.
5 Insert the pad again.
11
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22
55
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2.2.2. Setting the limitation for
CDS®Elbow Braces Extension L/L, M/M, S/S and Junior
The limitation restricts the range of motion.
Extension and the redression range are limited by the stop screw. In a second
step, the set value can be reduced up to a maximum of 15°, enabling infinitly
variable adjustment of the redression range.
1 Before setting the limitation, you must deactivate the spring tension. Turn the
switch to “off”.
2 Bring the brace into flexion.
3 On the side of the CDS®housing are three holes that are marked with the
degrees 0, 15 and 30. In the hole marked with 0 is the stop screw. Then turn
the stop screw with the supplied tool from the CDS®housing.
OFFOFF
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Before screwing it into one of the three holes, bring the brace into flexion, so
that the holes are freely accessible. Positon the stop screw in the desired position
and tighten the screw.
The limitation can be adjusted to the treatment progress with increasing mobility
of the patient.
Please be aware that the brace must only be used with the stop screw
positioned and tightend in one of the holes, otherwise the hinge will be
damaged.

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2.2.3. Fine adjustment for
CDS®Elbow Braces Extension L/L, M/M, S/S and Junior
Fine adjustment gives you the option of infinitely variable extension limitation.
1 Set the fine adjustment to a value between 0 and -15. The setting reduces
the limitation already set by the stop screw.
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User Instructions
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2.2.4. Inserting the stop wedge for
CDS®Elbow Braces Extension L/L, M/M, S/S and Junior
1 Flexion can be limited with the stop wedge.
2 Before adjusting the flexion limitation you must activate the spring tension.
Turn the switch to “on”.
3 Bring the brace into flexion until you feel a slight resistance that you have to
overcome in order to activate the spring tension.
4 On the side opposite of the three holes are five positions marked with the
degrees 0, 15, 30, 45 and 60. Insert the stop wedge in the desired position.
5 Fix it with the supplied screw.
ONON
223311
5544
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2.3. Application of the brace by the orthopaedic technician
2.3.1. Deactivate the spring tension
Before attaching the brace you must deactivate the spring tension.
1 Turn the switch to “off”.
2 Bring the brace as far into flexion as the patient is allowed to move. Now, the
activation mechanism of the hinge is set to this the position and the patient
can reactivate the spring tension in this position.
3 To facilitate attaching of the brace on the patients, adjust the length of all
brace straps to their maximum length without unthreading them. First open
the wide elastic upper arm strap. Now open the remaining straps by opening
the clips.
For XS/XS and Bambini, you must open and close the straps in order to attach
and remove the brace.
2233
OFFOFF
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2.3.2. Attaching the brace to the elbow
Place the brace on the patient‘s arm from below.
1 Ensure that the pivot of the brace hinge matches the physiological pivot of
the elbow. It is possible for you to adjust the arm rods to the shape of the
patient‘s arm by using an orthopaedic bending iron.
1
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2.3.3. Adjust strap lengths as necessary
Adjust the straps to the desired length and shorten them if necessary on the
strap end containing the doublesided hook end.
1 First fasten the narrow upper arm strap to secure it.
2 Fasten the forearm strap next to the joint.
3 Fasten the forearm strap further from the joint.
4 Fasten the wide, elastic upper arm strap.
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2.3.4. Final adjustment
After fastening the individual straps, check that the straps are the correct length
and that the brace is in the correct position, and correct if necessary. Ensure that
the straps are not too tight so as not to interfere with the circulation.
The shell elements are anatomically contoured. You can also shape the shell
elements with the hand to the arm contour directly on the patient.
If necesssary, the additional strap padding supplied with the product can be
attached under the straps.

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EN
2.3.5. Activate the spring tension
1 To activate the spring tension, turn the switch to “on”.
2 Bring the brace into flexion until you feel a slight resistance that you have to
overcome in order to activate the spring tension.
The intensity of the spring tension is not altered by activation or deactivation of
the spring tension.
ONON
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2.3.6. Setting the spring tension to the intensity needed
by the patient
1 The spring tension setting is displayed on the CDS®housing by a scale from
0 to 15. The ranges above 15 and below 0 are marked in red.
To prevent damage to the CDS®hinge, the red range in the CDS®
hinge window must be avoided.
2 Insert the tool as far as it will go into the side hole on the hinge. By turning
clockwise or towards + the spring tension is increased and it is decreased by
turning anticlockwise or towards -.
1122
The intensity of the spring tension is not altered by activation or deactivation of
the spring tension.
The spring tension may be adjusted only in consultation with the
treating physician.
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User Instructions
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0
0,2
0,4
0,6
0,8
1
1,2
1,4
1,6
1,8
2
2,2
2,4
2,6
2,8
3
3,2
3,4
3,6
3,8
4
4,2
4,4
4,6
4,8
5
5,2
5,4
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Settings
CDS®Nano hinge
CDS®hinge
Torque in Nm
Torque in Nm
The CDS®hinge is used for the sizes L/L, M/M , S/S and Junior.
The CDS®Nano hinge is used for the XS/XS and Bambini.
2.3.7. Changing the spring tension
The spring tension can be adjusted according to the to treatment progress.
Insert the tool as far as it will go into the side hole on the hinge. By turning
clockwise or towards + the spring tension is increased and it is decreased by
turning anticlockwise or towards -.
The spring tension may be adjusted only in consultation with the
treating physician.