Albrecht halluxsan 940A-L User manual

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.
Applications
Introduction
User Instructions
halluxsan®
Hallux valgus brace
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.
Declaration of conformity
The halluxsan hallux valgus brace conforms to the basic
requirements of European Directive 93/42/EEC concerning
medical devices. It bears the CE mark in accordance with this
directive.
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.
Safety notes
! Please follow these user instructions carefully.
! Do not use a damaged halluxsan brace.
! Makesureyouachievebestpossibleindividualadjustment
- see the section on Individual Adjustments
albrecht GmbH • Simser Weg 2 • D-83071 Stephanskirchen
Phone: [phone] • Fax: [phone]
www.albrechtgmbh.com
© albrecht GmbH
Patent DE 10 2008 049 854
halluxsan
halluxsan
Indication / Contra Indication
Hallux valgus
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.
Choice of size
The halluxsan brace is available in a single size for either
the right or the left foot as per the table below.
halluxsan
Dynamic redressing orthosis with adjustable spring joint
Disposal
The halluxsan contains recyclable materials without any
toxic or otherwise environmentally hazardous agents
or substances. Provided that it is not contaminated with
infectious germs it can be disposed of by normal means. In
order to be certain, please consult your orthopaedic store.
halluxsan art.-no.
left right colour
940A-L 940A-R green
940AS-L 940AS-R black
940AP-L 940AP-R pink
940AG-L 940AG-R gray

Fig.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.
Fig.2 Fig.3
Adjust the length of the foot strap (Fig.2) 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).
940-2 0314
Individual Adjustments
The footpiece and the toe support can be individually
adjusted by a specialist, by way of thermoplastic forming.
Care
Transfer Contact
The product is not supplied sterile and is not suitable for
sterilization. Do not use caustic or abrasive detergents. All
parts of the brace, which is otherwise maintenance-free, can
be hand washed at 30°C with water and a mild detergent
and / or disinfectant. For the choice of disinfectant, ask your
physician or chemist and read the notes of the disinfectant
manufacturer. The halluxsan brace can be dried with a
towel, or in the air.
The brace should be used by one person only. Should a
transfer to another person be nevertheless required, the care
instructions should be followed carefully. After thorough
cleaning, a specialist orthopaedic store must check the brace
carefully for its fitness for further use. In the event of even the
slightest damage to one of the components, the halluxsan
brace can no longer be used and must be disposed of.
albrecht GmbH
Simser Weg 2
D-83071 Stephanskirchen
Phone: [phone] / 303 29 - 0
Fax: [phone] / 303 29 – 20
www.albrechtgmbh.com
[email protected]
Technical data / Materials
Description Material
toe strap PA velour
shell strap 48% PA, 43% PES, 9% elastothane
padding PU foam material
halluxsan
halluxsan
halluxsan
Fig.4 Fig.5
The corrective force applied is increased by turning the
tension ring towards +.
The corrective force applied is reduced by turning the tension
ring towards -.
The scale from 1 to 5 shows the corrective force set.
The brace should only be attached or taken off when it is in
an untensioned condition.
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
The halluxsan brace is covered by a warranty for a period
of use of 3 months. The product is a medical rehabilitation
device and must not be used for any purposes other than
those described in the product information sheet. Any
modification of the product, or any application that is not
mentioned in the product information sheet, requires the
written consent of albrecht GmbH. In the absence of such
consent the manufacturer can offer no guarantee.
If any joints or components are to be used individually, they
must be used appropriately. If any parts or components
are modified or changed (e.g. by drilling for additional
attachments) the manufacturer will decline further warranty
coverage. Removing or damaging the QM seal will invalidate
the warranty.
Warranty
halluxs
metacarpophalangeal joint
brace hinge
Made in Germany
Hergestellt in Deutschland