Albrecht HALLUXSAN User manual

USER INSTRUCTIONS
HALLUXSAN®
HALLUX VALGUS BRACE

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.......................................................................................... 5
1.6. Declaration of conformity............................................................................. 5
1.7. Features ....................................................................................................... 5
1.8. Indications................................................................................................... 5
1.9. Contra-indications........................................................................................ 5
1.10. Safety Instructions...................................................................................... 6
1.11. Warranty .................................................................................................... 7
1.12. Transfer of the brace................................................................................... 7
1.13. Disposal ..................................................................................................... 7
2. Individual adjustments ............................................................................. 8
3. Cleaning, maintenance and disinfection ............................................. 10
3.1. Care........................................................................................................... 10
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halluxsan®
User Instructions

4. Technical data............................................................................................. 11
5. Size chart and article numbers............................................................... 11
6. Choice of size.............................................................................................. 11
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User Instructions

1. Introduction
1.1. Foreword
Hallux valgus is the medical term for a
deformity where the big toe sits at an angle to
the second toe.
The ball of the big toe ball protrudes, often
becoming the site of painful inflammation.
Dynamic tension applied in the opposite
direction countervails this development. Pain is
alleviated.
The
halluxsan brace can be used in both
conservative and post-operative treatment.
The halluxsan®brace should be worn without
shoes for several hours while resting or at
night.
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 halluxsan®functions according to the
CDS®-principle and has been designed to
treat hallux valgus (bunion). The brace applies
a dynamic low load prolonged stretch to
stimulate growth in the contracted tissue and
reduce pain. The adjustable redression
range protects the tissue of painful
overstretching.
1.4. Application
The brace must only be used for the orthotic
treatment of the hallux valgus.
Conservative treatment:
• Moderate hallux valgus with a mild to
moderate deformity (deviation of the toe).
• Onset of pain at the base joint of the big toe
with irritation of the bursa (apply ice pack
before treatment).
• Relapse after surgery (if the toe starts to
force itself outwards again).
• Preventive treatment if there is a family
predisposition to hallux valgus.
• Swelling of the bursa.
Pre-operative use in surgery preparation.
Post-operative treatment:
• Use only when the wound has stabilized and
once the stitches have been removed.
• The brace should not cause any pressure
points or severe pain.
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User Instructions

1.5. Scope of delivery
The halluxsan® brace is supplied to you ready
for use with the appropriate product labeling,
for the side of the foot you ordered, together
with user instructions. It is packed in a
protective carton.
Please check the contents for completeness.
1.6. Declaration of conformity
The albrecht GmbH company as manufacturer
with sole responsibility declares the conformity
of the halluxsan®brace with European Council
Directive 93/42/EEC for medical devices.
1.7. Features
• Therapy in the physiological position of the
big toe
• Pain reduction
• Individual adjustment of the tension spring
without tools
• Individual adjustment of the straps
• Easy handling and high wearing comfort
• Available in four colours
1.8. Indications
The physician will prescribe the fitting based
on his or her diagnostic findings.
Generally, the use is indicated in:
• Conservative treatment of moderate cases of
hallux valgus as well as preventive treatment
• Pre-surgical treatment in order to prepare
the soft tissue for surgery
• Post-surgical treatment in order to stabilize
the surgery result
The brace MUST NOT be worn in the event of
soft tissue problems, problems with wound
healing, infections, etc. The doctor should be
consulted for any indications not listed above.
For all other indications a physician must be
consulted.
1.9. Contra-indications
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
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.
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User Instructions

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 User Instructions. 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.
1.12. Transfer of the brace
The brace is not intended for single use, but
rather is intended for multiple use by a single
person. We do not recommend transfer to
other users. Should this be desired however,
please ensure to pass on the care and cleaning
instructions and have the brace checked by an
authorized specialist dealer for safe and proper
operation.
1.13. Disposal
The brace contains recyclable materials
without toxic or other harmful substances or
other environmentally hazardous substances.
Provided it is not contaminated with infectious
germs, the brace can be deposited in the
normal waste disposal. To be sure, consult
your specialist orthopaedics dealer.
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User Instructions

2. Individual adjustments
The footpiece and the toe support can be individually adjusted by a specialist, by
way of thermoplastic forming.
1� Attach the
halluxsan brace with its footpiece and its toe support (Fig.1) to
your foot. Please take care, that the joint axis of the brace lies behind the
hallux metacarpophalangeal joint. Pressure must not be exerted on the ball
of the foot.
2� Adjust the length of the foot strap (Fig.2)
3� and the length of the toe strap (Fig.3).
Ensure correct and painfree positioning.
When attaching and taking off the brace, the straps do not have to be pulled
out of their lugs, in order to obtain the intended belt guide (direction of
tension).
halluxs
metacarpophalangeal joint
brace hinge
1 2 3
4� The corrective force applied is increased by turning the tension ring towards
+.
The corrective force applied is reduced by turning the tension ring towards -.
5� The scale from 1 to 5 shows the corrective force set.
4 5
The brace should only be attached or taken off when it is in an untensioned
condition.
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halluxsan®
User Instructions

The adjustment of spring tension may only be carried out after
consulting the attending physician.
1,1
1,6
3,1
4,9
6,8
0
1
2
3
4
5
6
7
12345
halluxsan corrective force
spring setting
corrective force in N
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User Instructions

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 halluxsan® 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 http://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
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User Instructions

Description Material
toe strap PA velour
shell strap 48% PA, 43% PES, 9% elastothane
padding PU foam material
4. Technical data
6. Choice of size
The halluxsan® brace is available in a single size for either the right or the left foot as shown in the
table below.
5. Size chart and article numbers
Art.-No.: left foot Art.-No.: right foot Colour
940A-L 940A-R green
940AS-L 940AS-R black
940AP-L 940AP-R pink
940AG-L 940AG-R grey
Optionally available in pairs: suitable socks in black
EU shoe size Art.-No. Sock for right and and left foot
35 - 38 70001
39 - 42 70002
43 - 46 70003
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User Instructions

HMV-Nr.: 23.01.01.1003
PATENTS: DE 10 2008 049 854
VERSION: EN 07.2019
albrecht GmbH
CHIEMSEESTRASSE 81
D-83233 BERNAU AM CHIEMSEE / GERMANY
PHONE [phone]
FAX [phone]
[email protected]
WWW.ALBRECHTGMBH.COM