Albrecht CDS ANKLE BRACE NEURO User manual

USER INSTRUCTIONS
CDS®ANKLE BRACE NEURO
DYNAMIC SPRING-LOADED ANKLE ORTHOSIS

2
CDS®Ankle Brace Neuro
User Instructions
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. Adjustment by the orthopaedic technician .......................................... 7
2.1. Fitting to the patient .................................................................................... 7
2.1.1. Adjusting the brace to the leg shape by using
an orthopaedic “bending iron” ..................................................................... 7
2.1.2. Optional installation of the brace covers ............................................. 8
2.1.3. Adjusting the distance between the hinge rods................................... 9
2.2. Adjusting the brace.................................................................................... 10
2.2.1. Setting the limitation......................................................................... 10
2.2.2. Fine adjustment................................................................................. 11
2.2.3. Changing the working range of the CDS®Ankle Brace
in extreme dorsiflexion................................................................................ 12

www.albrechtgmbh.com 3
User Instructions
2.3. Attaching of the brace by the orthopaedic technician ................................. 13
2.3.1. Deactivate the spring tension ............................................................ 13
2.3.2. Setting rotation on the foot part ...................................................... 15
2.3.3. Setting pronation or supination on the foot part .............................. 16
2.3.4. Adjusting the vacuum foot rest ........................................................ 17
2.3.5. Final adjustment................................................................................ 19
2.3.6. Activate the spring tension ............................................................... 19
2.3.7. Setting the spring tension to the intensity needed by the patient..... 20
2.3.8. Changing the spring tension ............................................................. 21
2.3.9. Removing the brace........................................................................... 22
3. Cleaning, maintenance and disinfection ............................................. 23
3.1. Care........................................................................................................... 23
4. Technical data............................................................................................. 24
5. Size chart and article numbers............................................................... 24
6. Transfer of the brace ................................................................................ 25
7. Disposal........................................................................................................ 25

4
CDS®Ankle Brace Neuro
User Instructions
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®Ankle Brace Neuro functions
according to the CDS®-principle and has been
designed to treat an extension deficit of the
ankle. The brace applies a dynamic low load
prolonged stretch to stimulate growth in the
contracted tissue. The adjustable redression
range protects the tissue from painful
overstretching.
1.4. Application
The brace has been designed exclusively for
the orthotic treatment of the ankle joint and
for contact with intact skin.
1.5. Scope of delivery
Please check the completeness of the brace at
delivery.
• Brace with padding and straps and vacuum
foot rest
• albrechtGmbH hexagon key
• User Instructions
• Vacuum pump
1.6. Declaration of conformity
The albrecht GmbH company as manufacturer
with sole responsibility declares the conformity
of the CDS®Ankle Brace Neuro with European
Council Directive 93/42/EEC for medical
devices.

www.albrechtgmbh.com 5
User Instructions
1.7. Features
• Therapy in dorsalextension
• Small hinge with proven features:
– Individual adjustment of the spring
tension
– Spring tension can be switched on and off
without tools and without varying the set
spring tension
– Infinitely variable adjustment of the
redression range in dorsalextension
• All-over and secure fixation by vacuum
grip
– Individually adjustable inlay
– Adjustable pronation and supination
– Adjustable rotation
– Including vacuum pump
• Optimized paddingsystem
- Easy attachment thanks to flexible pads
- Optionally attachable hinge covers
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 strokes
– After spinal cord injuries
– Paralysis (discrete palsy of peripheral
origin)
– After cranio-cerebral trauma (CCT)
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.

6
CDS®Ankle Brace Neuro
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.
• 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.
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.

www.albrechtgmbh.com 7
User Instructions
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 leg shape by using an orthopaedic
“bending iron”
To ensure that the brace fits perfectly, the hinge rods can be adjusted to the
shape of the patient‘s leg with the aid of a bending iron.
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.

8
CDS®Ankle Brace Neuro
User Instructions
2.1.2. Optional installation of the brace covers
1.Stick the big adhesive coin onto the hinge rod underneath the fine
adjustment.
2.Stick the three small adhesive coins onto the hinge.
3.Hook-and-loop fasten the gripper to the calf pad.
4.Pull the cut out pad over the hinge and hook-and-loop fasten it to the
hinge rod.
5.Position the second pad on the hinge and hook-and-loop fasten it to the
gripper.
1
3
5
2
4

www.albrechtgmbh.com 9
User Instructions
2.1.3. Adjusting the distance between the hinge rods
1.You can change the distance of the hinge rods from the lateral edge of the
sole.
2.To do so, loosen the screws in the sole plate.
3.Move the hinge rods singly.
4.When the optimal position of both rods has been found, fix the footbar
again.
1
3
2
4

10
CDS®Ankle Brace Neuro
User Instructions
2.2. Adjusting the brace
2.2.1. Setting the limitation
Before setting the limitation, you must deactivate the spring tension.
1.Turn the switch to “off”.
2.Bring the brace into plantar extension.
3.Then turn the stop screw with the supplied tool from the CDS®housing.
Before screwing it into one of the three holes, bring the brace into maximum
plantar extension. This prevents the stop screw from making contact with the
mobile hinge rod when it is tightened, which could damage the CDS® housing.
2 3
OFF
1
The limitation should be adjusted to treatment progress with increasing motility.

www.albrechtgmbh.com 11
User Instructions
2.2.2. Fine adjustment
Fine adjustment gives you the option of infinitely variable limitation (stop).
Ensure that the spring tension is deactivated.
1.Set the flexion stop according to the scale (0-15). The setting reduces the
already set limitation.
1 11

12
CDS®Ankle Brace Neuro
User Instructions
2.2.3. Changing the working range of the CDS®Ankle Brace in
extreme dorsiflexion
In neurological patients it may be necessary to bring the working range of the
CDS®Ankle Brace Neuro further into dorsiflexion than the factory setting.
This adjustment is made possible by rotating the hinge capsule relative to the
lower leg hinge rod. To do this, there are two screws on the inside of the hinge
capsule. By removing these screws, you can adjust the hinge capsule to the
required working range in 15° steps.
1.Remove the pad.
2.Remove the screws with the supplied tool.
3.Set the required angle.
4.Insert the screws again and tighten them.
5.Insert the pad.
The setting must be the same for both hinges.
1
4 5
32

www.albrechtgmbh.com 13
User Instructions
2.3. Attaching 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 green switch to “off”.
2.Bring the brace into plantar extension.
3.Open the strap fasteners
To make it easier to apply the brace to the patient, adjust the length of the
lower leg straps to their maximum length without unthreading them. Open
the instep and toe strap.
2
OFF
1 3

14
CDS®Ankle Brace Neuro
User Instructions
4.Attaching the brace
Ensure that the pivot of the brace hinges matches the physiological pivot of
the ankle. It is possible to adjust the thigh rods to the shape of the patient‘s
leg by using a bending iron. Ensure that the hinges are as parallel to one
another as possible to ensure wear-free function of the brace.
4

www.albrechtgmbh.com 15
User Instructions
2.3.2. Setting rotation on the foot part
The foot piece is preset to 0°. However, it is possible for you to set the angle of
rotation to 15° or 30°.
1.Remove the pad beneath the sole.
2.Loosen the fixing screw with the supplied tool.
3.Unscrew the adjusting screw.
4.Position the foot piece at the number of degrees required by the patient.
5.Insert the adjusting screw again and tighten it.
6.Tighten the fixing screw.
1
4
2
5
3
6

16
CDS®Ankle Brace Neuro
User Instructions
2.3.3. Setting pronation or supination on the foot part
1.Loosen the screws of the two terminal blocks with the supplied tool.
2.Turn the sole part into the desired pronation or supination and tighten the
two screws again.
3.Insert the pad again.
1
3 3
2

www.albrechtgmbh.com 17
User Instructions
2.3.4. Adjusting the vacuum foot rest
Adjust the straps to the desired length and shorten them as needed.
1.Open the two foot straps.
2.Place the brace on the patient’s leg.
3.Close the two lower leg straps.
4.Close the two foot straps.
5.Attach the valve of the vacuum pump to the vacuum pad valve connector
without pressing the grey release button. Please note: the two valves must
lock audibly.
1
4
2
5
3

18
CDS®Ankle Brace Neuro
User Instructions
6.Aspirate all the air from the vacuum pad with the vacuum pump. Please note:
the air is fully aspirated when you feel obvious resistance when pumping.
7.Detach the valve of the vacuum pump from the vacuum pad valve connector
of the by pressing the grey release button.
8.Open the foot straps again to retighten them and close them again.
9.Brace in place.
6 7
98
8

www.albrechtgmbh.com 19
User Instructions
2.3.5. Final adjustment
After fastening the individual straps, check that the straps are the correct length
and that the brace is in correct position, and correct if necessary. Ensure that the
straps are not too tight so as not to interfere with the circulation.
2.3.6. Activate the spring tension
1.To activate the spring tension, turn the green switch to “on”.
2.Bring the brace into plantar extension.
The intensity of the spring tension is not altered by activation or deactivation of
the spring tension.
ON
1 2

20
CDS®Ankle Brace Neuro
User Instructions
2.3.7. 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 -.
The intensity of the spring tension must be equal in both hinges. 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.
1 2