Albrecht HYPEX LITE User manual

USER INSTRUCTIONS
HYPEX®LITE
KNEE ORTHOSIS
WITH 4-POINT-PRINCIPLE AND EXTENSION- / FLEXIONLIMITATION

Hypex®Lite
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
2
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 notes ............................................................................................ 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
2.2. Setting the hinge for Hypex®Lite L/L, L/M, M/L, S/S and Junior ......... 8
2.2.1. Opening of the hinge cover ........................................................... 8
2.2.2. Setting the extension limitation.................................................... 9
2.2.3. Setting the fine adjustment......................................................... 10
2.2.4. Setting the flexion limitation....................................................... 10
2.2.5. Immobilisation ............................................................................... 11
2.2.6. Unlimited flexion ........................................................................... 12

User Instructions
www.albrechtgmbh.com 3
2.3. Setting the hinge for Hypex®Lite XS/XS, XXS, Bambini and Malinki 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. Attaching the brace....................................................................... 16
2.4.2. Using the clips ............................................................................... 17
3. Cleaning, maintenance and disinfection.............................................. 18
3.1. Care ......................................................................................................... 18
4. Technical data............................................................................................. 19
5. Size chart and article numbers ............................................................... 20
6. Transfer ........................................................................................................ 21
7. Disposal ........................................................................................................ 21

Hypex®Lite
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
4
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 this customer
information sheet carefully before using the
brace. Proper use and operation of the brace
will only be possible if you have carefully read
and understood all instructions, notes and
procedures. Should you have any doubts with
regard to the user instructions, or should any
of the instructions, operations or safety notes
be unclear, please contact your local dealer
or the manufacturer albrechtGmbH directly
before using the brace. This holds particularly
true for the safety notes.
1.3. Mode of operation
The Hypex®Lite Knee Brace stabilises and
relieves the knee during conservative and
post-operative rehabilitation. Straps and shells
may be adjusted individually for high wearing
comfort.
The continuously variable extension
limit between + 45° and -15° allows for
individual terminal extension.
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
• User instructions
1.6. Declaration of conformity
The albrechtGmbH company, as the
manufacturer solely responsible, declares that
the Hypex®Lite conforms to the Regulation
(EU) 2017/745 Concerning Medical Devices.

User Instructions
www.albrechtgmbh.com 5
1.7. Features
• Anatomically formed hinge rods and shells
• Individually adjustable straps
• Limits can be adjusted without tools
• Easy handling and high wearing comfort
Hypex®Lite L/L, M/L, L/M, S/S and Junior:
• Continuously adjustable extension
between -15° and 45° to allow for
physiological hyperextension of the knee
• Flexion can be adjusted in 15° intervals
up to 90° (max flexion 130°)
• Continuous immobilisation of the brace
between -15° and 45°
Hypex®Lite XS/XS, XXS, Bambini and
Malinki:
• 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 will decide on the type of
treatment to apply based on his diagnosis.
Generally, the use is indicated in:
• Collateral ligament injuries
• ACL and PCL ruptures
• Meniscus injury
• Femur condyle fracture
• Patella fracture
• Tibial plateau fracture
• Condition after meniscus reconstruction
• Condition after microfracturation,
Pridie drilling
• Condition after abrasion chondroplasty
• Condition after cartilage transplantation
• Condition after osteotomies (procedures)
• Patella luxation
• Moderate instability of the knee
• Multiligamentous instability
• Genu recurvatum
For all aberrant indications the physician has to
be asked.
1.9. Contra indications
• Massive circulatory disorder
• Massive varikosis

Hypex®Lite
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
6
1.10. Safety notes
• The maximum effectiveness of the brace will
only be achieved if it is used correctly.
• The brace is only to be used in an intact,
complete, mechanically faultless condition
with complete and undamaged padding and
straps. Prior to each use, the user should
check that these conditions are met.
• Failure to close one or more of the straps,
or their removal, or any excessive loosening
of the straps during usage will diminish the
therapeutic effect of the brace and may
cause injuries.
• The brace must not be worn on open
wounds.
• The skin should be free of oils, greases,
gels or other residues in order to avoid
skin reactions or reactions on the material
structure.
• The brace should be tight, but not too tight -
so as not to adversely affect circulation. Thus
excessive compression should be avoided.
• A combination with other products is
currently not foreseen and must thus be
agreed with the manufacturer in writing.
• The brace is not a single-use product, but
has been designed for use by one person
only.
• The product is not supplied in a sterile
condition.
• When adjusting the hinge rods to the shape
of the extremity 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.
• In case of allergic reactions, immediately
contact your physician.
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.

User Instructions
www.albrechtgmbh.com 7
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 extremity 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.
Please note:
• The setting for both hinges must be the same.
• Both stop pins of each hinge must be in the pin holes.
• The hinge covers must always be closed after any adjustment.

Hypex®Lite
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
8
2.2. Setting the hinge for Hypex®Lite L/L, L/M, M/L, S/S and
Junior
Extension and flexion can be limited in 15° 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.
2.2.1. Opening of the hinge cover
1 Open the hinge cover.
Monocentrical hinge Polycentrical hinge*
1
1
1
1
Monocentrical hinge Polycentrical hinge*
1
1
1
1

User Instructions
www.albrechtgmbh.com 9
2.2.2. Setting the extension limitation
1 In order to set the extension limitation, bring the brace into flexion.
Monocentrical hinge Polycentrical hinge*
1
1
1
1
2 Place the stop pin into the desired position.
Monocentrical hinge Polycentrical hinge*
2
2
2
2
* not at S/S and Junior

Hypex®Lite
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
10
2.2.3. Setting the fine adjustment
1 Additionally, the extension limtation can be adjusted infinitely using the fine
adjustment from 45° via 0° to -15°.
Monocentrical hinge Polycentrical hinge*
1111
2.2.4. Setting the flexion limitation
1 In order to set the flexion limitation, bring the brace into extension.
Polycentrical hinge*Monocentrical hinge
1111

User Instructions
www.albrechtgmbh.com 11
2 Place the stop pin into the desired position.
Monocentrical hinge Polycentrical hinge*
2222
2.2.5. Immobilisation
1 Immobilisation can be set in 15° steps by appropriate positioning of a stop
pin in the stop area. Additionally, the set immobilisation can be infinitely
adjusted from 45° via 0° to -15° using the fine adjustment.
Monocentrical hinge Polycentrical hinge*
1111
* not at S/S and Junior

Hypex®Lite
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
12
2.2.6. Unlimited flexion
1 For unlimited flexion put one stop pin into the position ∞.
2 Make sure that both stop pins are placed in the pinholes and that there is
always at least one stop pin positioned in the pinholes of the extension stops.
Polycentrical hinge*Monocentrical hinge
Monocentrical hinge Polycentrical hinge*
1
1
2
2
1
1
2
2
The hinge cover must always be closed after any adjustment in order to secure
the stop pins.
* not at S/S and Junior

User Instructions
www.albrechtgmbh.com 13
2.3. Setting the hinge for Hypex®Lite XS/XS, XXS, Bambini
and Malinki
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.
111122

Hypex®Lite
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
14
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
1
2
2
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
1
2
2
2
2

User Instructions
www.albrechtgmbh.com 15
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.
1122

Hypex®Lite
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
16
2.4. Attaching of the brace by the orthopaedic technician
2.4.1. Attaching the brace
1 Preparation:
Adjust the length of the anterior brace straps. The straps do not have to be pulled out of their
lugs. Release the posterior straps by opening the buckles.
2 Attaching:
Bend your knee to an angle of approx. 30°
to 45° and align the orthosis corresponding
to picture 1 on your knee. Make sure to
align the pivotal points of the orthosis
hinges with the pivotal point of the knee.
Position: Mid patella, posterior third of the
joint. By adjusting the anterior straps, this
step is made easier when attaching the
brace for the first time.
3 Fixation:
When fastening the posterior straps, slightly
tighten the anterior straps. The following
sequence is recommended:
1. Upper calf strap
2. Upper tibia strap
3. Upper posterior thigh strap
4. Upper anterior thigh strap
5. Posterior thigh strap near hinge
6. Anterior thigh strap near hinge
7. Lower posterior calf strap
8. Lower anterior calf strap
1
1
2
2
3
3







To achieve optimal fit the two calf straps near the hinge must be fastened tightly. Their purpose
is to ensure no migration by being positioned on the belly of the gastrocnemius (calf).
After fastening the single straps, check the correct position of the brace and if necessary,
re-adjust it. Please take care, that the straps are not fastened too tightly, so that blood circulation
is not affected.

User Instructions
www.albrechtgmbh.com 17
2.4.2. Using the clips
1 Open the clip.
2 Hook in the D-Ring.
3 Close the clip.
The length of the straps remains unchanged.
The sizes XS/XS, XXS, Bambini and Malinki are opened and closed
using the straps.
112233

Hypex®Lite
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
18
3. 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.
3.1. 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 Hypex®Lite 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.
h
Hand wash at 30°C
C
Do not bleach
t
Do not iron
k
Do not dry-clean
y
Do not tumble dry

User Instructions
www.albrechtgmbh.com 19
4. Technical data
Name Material
Padding material PU foam with PA hook and loop velour
Strap material PA strap with PA hook and loop velour
Brace material aluminium
Weight 876g

Hypex®Lite
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
20
5. Size chart and article numbers
The girths of the braces correspond to the shell sizes.
Name
Length of
thigh shell
medial
Length of
lower leg shell
Circumfe-
rence
of thigh
Circumference
of lower leg
Art.-No.
left
Art.-No.
right
Hypex®Lite L/L 24 cm 26,5 cm 36 - 66 cm 27 - 47 cm 804LL-L 804LL-R
Hypex®Lite L/M 19 - 23 cm 25 - 28 cm 33 - 44 cm 24 - 35 cm 804LM-L 804LM-R
Hypex®Lite M/L 18 - 21 cm 20 - 23 cm 36 - 63 cm 27 - 45 cm 804ML-L 804ML-R
Hypex®Lite M/S 17 - 20 cm 21 - 25 cm 36 - 63 cm 22 - 32 cm 804MS-L 804MS-R
Hypex®Lite S/S 18 cm 20 cm 30 - 40 cm 22 - 32 cm 804SS-L 804SS-R
Hypex®Lite XS/XS 15 cm 18 cm 25 - 35 cm 20 - 30 cm 804XSXS-L 804XSXS-R
Hypex®Lite XXS 12 cm 15 cm 20 - 30 cm 15 - 25 cm 804XXS-L 804XXS-R
Junior Grün 18 cm 20 cm 30 - 40 cm 22 - 32 cm 804SS-GL 804SS-GR
Junior Blau 18 cm 20 cm 30 - 40 cm 22 - 32 cm 804SS-BL 804SS-BR
Junior Orange 18 cm 20 cm 30 - 40 cm 22 - 32 cm 804SS-OL 804SS-OR
Junior Pink 18 cm 20 cm 30 - 40 cm 22 - 32 cm 804SS-PL 804SS-PR
Bambini Grün 15 cm 18 cm 25 - 35 cm 20 - 30 cm 804XSXS-GL 804XSXS-GR
Bambini Blau 15 cm 18 cm 25 - 35 cm 20 - 30 cm 804XSXS-BL 804XSXS-BR
Bambini Orange 15 cm 18 cm 25 - 35 cm 20 - 30 cm 804XSXS-OL 804XSXS-OR
Bambini Pink 15 cm 18 cm 25 - 35 cm 20 - 30 cm 804XSXS-PL 804XSXS-PR
Malinki Grün 12 cm 15 cm 20 - 30 cm 15 - 25 cm 804XXS-GL 804XXS-GR
Malinki Blau 12 cm 15 cm 20 - 30 cm 15 - 25 cm 804XXS-BL 804XXS-BR
Malinki Orange 12 cm 15 cm 20 - 30 cm 15 - 25 cm 804XXS-OL 804XXS-OR
Malinki Pink 12 cm 15 cm 20 - 30 cm 15 - 25 cm 804XXS-PL 804XXS-PR