Albrecht JACK PCL BRACE User manual

USER INSTRUCTIONS
JACK PCL BRACE
DYNAMIC KNEE BRACE
TO RELIEVE THE POSTERIOR CRUCIATE LIGAMENT

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. Contra-indications........................................................................................ 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. Setting the shell components .............................................................. 8
2.1.3. Adjustment of limitation stops ............................................................ 9
2.1.4. Setting the flexion limitation............................................................. 10
2.1.5. Setting the extension limitation......................................................... 11
2.1.6. Adjusting immobilisation................................................................... 12
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2.2. Attaching of the brace by the orthopaedic technician ................................. 14
2.2.1. Deactivating the tension spring ......................................................... 14
2.2.2. Fitting the brace to the leg................................................................ 15
2.2.3. Final readjustment............................................................................. 18
2.2.4. Activate spring tension...................................................................... 19
2.2.5. Adjusting spring tension to the intensity
required by the patient................................................................................ 20
2.2.6. Altering spring tension...................................................................... 20
3. Handling by the patient........................................................................... 21
3.1. Removing the brace.................................................................................... 21
3.1.1. Deactivating spring tension................................................................ 21
3.1.2. Open the buckles of the straps (on upper and lower shells) .............. 22
3.2. Fitting the brace ........................................................................................ 23
3.2.1. Deactivating spring tension ............................................................... 23
3.2.2. Fitting the brace to the leg................................................................ 24
3.2.3. Activate spring tension...................................................................... 25
4. Cleaning, maintenance and disinfection ............................................. 26
4.1. Care Instructions........................................................................................ 26
5. Technical data............................................................................................. 27
6. Size chart and article numbers............................................................... 27
7. Transfer of the brace................................................................................. 28
8. Disposal ....................................................................................................... 28
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User Instructions

1. Introduction
1.1. Foreword
Functional braces relief and stabilize joints
and ligaments after trauma and surgery. They
support joints and ligaments in the healing
process while maintaining the natural range of
motion.
Whilst protecting fragile joints and ligaments
during rehabilitation, our functional braces are
also designed to allow a guided, step by step
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 Jack PCL Brace overcomes the gravity
of the lower leg to relieve the posterior
cruciate ligament. The translation force may
be adjusted to the leg and weight of the
patient through setting the tension on both
sides of the brace. Hereby the detrimental
effects of the muscle and gravitation forces
can be counteracted. The slipping of the
tibia into the posterior drawer position is
prevented.
1.4. Application
The brace has been designed exclusively for
the orthotic treatment of the knee 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
• albrechtGmbH hexagon key
• User Instructions
1.6. Declaration of conformity
The albrechtGmbH company as manufacturer
with sole responsibility declares the conformity
of the Jack PCL Brace with European Council
Directive 93/42/EEC for medical devices.
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1.7. Features
• Constant translation force irrespective of
flexion angle
• Optimised hinge geometry
• Small hinge with proven features:
– Spring force can be adjusted infinitely and
individually
– Spring force can be easily increased or
reduced at any time
– Spring tension can be switched on and off
without tools whilst retaining the set
pressure force at the calf shell
– Limitation in 15° increments in extension
and flexion
– Extension limitation 0° / 15° / 30° / 45°
– Flexion limitation 60° / 75° / 90° / 105° /
120°
– ROM possible from 0° to 120°
– Temporary immobilisation possible
• Optimised shell and strap system:
– High level of wearing comfort due to
breathable, lightweight aluminium thigh
shells
– High flexibility due to adjustable,
customisable thigh shells
– Extended size system, incl. paediatric sizes
– Modular elements that can be combined
with one another
– Anatomically shaped tibia shell to improve
pressure distribution
– Strap system can be adjusted to suit
individual requirements
– Easy handling and high level of wearing
comfort
1.8. Indications
The physician will prescribe the fitting based
on diagnostic findings.
Generally, the use is indicated for:
• PCL ruptures
• Partial ruptures and elongations of the PCL
For all other indications a physician must be
consulted.
1.9. Contra-indications
• Massive circulatory disorder
• Massive varicosis
The brace is only intended for use in 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 pads
and straps. This must be verified by the user
before each usage.
• Opening or removing one or more straps,
as well as excessive loosening of the straps
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 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
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
2.1.1. Adjusting the brace to the leg 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 leg 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.
The Jack PCL Brace can only be adjusted at the thigh rods, due to constructive
reasons.
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User Instructions

2.1.2. Setting the shell components
The shell components are moveable to adjust the length of the brace.
1.Loosen the screws on the shell components with the supplied hexagon key
without unscrewing them completly.
2.Move the shell components into the desired position.
3.Tighten the screws again.
1 2 3
The shell components can be adjusted to the contour of the extremity
by gently pressing them on the leg.
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2.1.3. Adjustment of limitation stops
To restrict extension and flexion the limitation can be adjusted in 15° increments.
At both hinges, all the steps in the procedure must be performed in an identical
manner.
1.To be able to make hinge adjustments you must remove the condylar pad on
the inside of the hinge.
2.Now undo the screws on the cover and then remove them.
3.Under the cover there are stops for extension and flexion. They each consist
of a stop bridge connected to a spring plate. The factory settings for
extension and flexion are 0° and 120°, respectively.
1 2
3
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User Instructions

2.1.4. Setting the flexion limitation
4.To adjust the flexion stop, move the brace to maximum extension.
5.Raise the flexion stop with your fingernail until the stop is disengaged from
the set position and can be moved round the centre of the hinge with the
spring plate.
6.Insert the flexion stop in the recess at the position required.
Please bear in mind that excessive bending of the spring plate can result
in damage.
4
6
5
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2.1.5. Setting the extension limitation
7 To adjust the extension stop, move the brace to flexion against the flexion
stop you have already adjusted.
8 Raise the extension stop with your fingernail until the stop is disengaged
from the set position and can be moved round the centre of the hinge with
the spring plate.
9 Insert the extension stop in the recess at the position required. Please
bear in mind that excessive bending of the spring plate can result in
damage.
7 8 9
To secure the stops, fit the cover back on again and fasten it down with the
screws you previously removed.
Reattach the condylar pads to the hinge.
At both hinges, all the steps in the procedure must be performed in an
identical manner.
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User Instructions

2.1.6. Adjusting immobilisation
For immobilisation the hinge can be adjusted in 15° increments.
1.To be able to perform
immobilisation you must remove the
condylar pad on the inside of the
hinge.
2.Now undo the screws on the cover
and then remove them.
3.Under the cover there are stops for
extension and flexion. They each
consist of a stop bridge connected
to a spring plate. The factory
settings for extension and flexion
are 0° and 120°, respectively.
4.To set immobilisation, move the
brace to maximum flexion.
5.Raise the extension stop with
your fingernail until the stop is
disengaged from the set position
and can be moved round the centre
of the hinge with the spring plate.
6.Insert the extension stop in the
milled recess at the position
required.
21 3
4 5 6
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7.For immobilisation, then move
the brace to extension against the
extension stop you have already
adjusted.
8.Raise the flexion stop with
your fingernail until the stop is
disengaged from the set position
and can be moved round the centre
of the hinge with the spring plate.
9.Place the flexion stop directly next
to the extension stop.

To secure the stops, fit the cover
back on again and fasten it down
with the screws you previously
removed.

Re-attach the condylar pads to the
hinge.
At both hinges, all the steps in the procedure must be performed in an
identical manner.
7 8 9
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User Instructions

2.2. Attaching of the brace by the orthopaedic technician
2.2.1. Deactivating the tension spring
1.Before fitting the brace, you must deactivate spring tension. First, set the
levers of both hinges to the „off“ position.
2.To deactivate spring tension you must push the lower leg shell to posterior. To
do so, grasp under the hinge bar with your hands and position your thumbs
on the pressure blocks attached to the lower leg shell.
3.Using your thumbs on the pressure blocks, push the shell to posterior against
the spring tension. The anterior directed spring force is now deactivated.
OFF
1 2 3
To make it easier to fit the brace to the patient, adjust the length of all
the brace straps to maximum length without unthreading them.
Now release the anterior straps from the thigh shell and lower leg shell by
opening the buckles.
Then remove the two anterior additional shells from the upper and
lower legs.
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2.2.2. Fitting the brace to the leg
4 Fit the brace to the patient‘s leg from behind. Ensure that the pivots of the
brace hinges match the physiological pivots of the knee.
4
It is possible to adjust the thigh rods to the shape of the patient’s leg by using an
orthopaedic bending iron.
Make sure the hinges are as parallel as possible to one another in order to
ensure wear-free operation of the brace. The lower leg shell was intentionally
designed to be solid without ventilation windows to prevent oedemas.
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User Instructions

5
Now position the additional shell on the thigh. Please bear in mind that the
additional shell must be located within the lateral thigh shells.
6
Then place the anterior distal thigh strap over the additional shell and close
it with the buckle. Adjust the length of the strap so that the thigh shells are
parallel to the thigh.
7Now adjust the length of the posterior distal strap so that the thigh shells are
parallel to the thigh.
8Then adjust the length of the posterior proximal strap and continue to make
sure that the shells are parallel to the thigh.
9
Now close the anterior proximal thigh strap over the additional shell. Readjust
the strap if necessary.
5
7 8 9
6
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Now fit the lower leg shell to the patient‘s calf.
Then place the tibia shell on the shin.
Close the tibia strap over the the tibia shell.
Readjust the strap if necessary.
Ensure that the pivots of the brace hinges match the physiological
pivots of the knee.
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User Instructions

2.2.3. Final readjustment
Having closed the individual straps, check the
set strap lengths and appropriate positioning
of the brace, correcting them if necessary.
Make sure the straps are not too tight, so as
not to impair blood circulation.
To enable the spring force of the brace to act
properly, the straps marked in red must be
tightened sufficiently.
1.Tibia strap
2.Distal anterior thigh strap
3.Posterior proximal thigh strap
If any of these straps should become
loose or if they have been set too loosely,
the brace will not function properly.
1
2
3
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2.2.4. Activate spring tension
1.To activate the spring tension of the brace, and hence enable it to function,
set the levers of both hinges to the „on“ position.
2.To activate spring tension you must push the lower leg shell to posterior. To
do so, grasp under the hinge bar with your hands and position your thumbs
on the pressure blocks attached to the lower leg shell.
3.Using your thumbs on the pressure blocks, push the shell to posterior. The
anterior directed spring force is now activated.
3
2
ON
1
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User Instructions

2.2.5. Adjusting spring tension to the intensity
required by the patient
1.Through the window in the PCL casing the set spring force is indicated on a
scale from 0 to 15. The ranges above 15 and below 0 are marked in red.
To prevent damage to the PCL hinge, it must not be rotated into the
red zone of the window on the PCL hinge.
2.Insert the tool into the lateral hole in the hinge as far as it will go. Turning
clockwise or in the + direction increases spring tension whilst turning
anticlockwise or in the - direction reduces spring tension.
1 2
2.2.6. Altering spring tension
Spring tension can be adjusted according to the progress of treatment.
Insert the tool into the lateral hole in the hinge as far as it will go. Turning
clockwise or in the + direction increases spring tension whilst turning
anticlockwise or in the - direction reduces spring tension.
The intensity of spring tension must be identical on both hinges.
Adjustment of spring force may only be performed in agreement with
the attending physician.
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