Albrecht MKS OSTEO FLEX User manual

USER INSTRUCTIONS
MKS®OSTEO FLEX
SPINAL ORTHOSIS

T3 - L5
1. Introduction
1.1. Foreword
Our MKS®Modular Corset System straightens
and stabilizes defined areas of the vertebral
column in order to achieve postural corrections
which actively support rehabilitation in specific
indications.
Our MKS®programme is comprised of a
modular system which can be divided into
an orthesis set consisting of rigid supportive
elements and a set of partially elastic,
smoothly-fitting back-and-body bandages
which adapt comfortably to the body.
By combining the individual components of
the two sets an exact adjustment to both the
respective indication and the patient can be
achieved.
1.2. Customer information
For your own safety, please read this User
Instructions 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 MKS®Osteo flex spinal orthosis functions
according to the reclination principle. The
two shoulder straps attached to the fexible
back piece straighten the vertebral column to
relieve the thoracic spine. The wide lumbar
bandage with the additional tensioning straps
straightens and hence relieves the lumbar
vertebral column. The reclination straps are
attached to the lumbar bandage through
additional lateral straps. Hereby rotation is
limited and stabilisation is ensured.
1.4. Application
The brace must only be used for the orthotic
treatment of the vertebral
column.
The MKS®Osteo flex
assists treatment in the
application area from the
third thoracic vertebral body
to the fifth lumbar vertebral
body in adults. It provides
stabilization of the entire
spine. The MKS®Osteo
flex is intended to help you
achieve a lifestyle that is
as independent as possible
while still meeting your
needs and matching your
personal capabilities.
1.5. Scope of delivery
The MKS®Osteo flex is delivered to you ready
for use, in the size you ordered, with User
Instructions and labeling on the product.
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User Instructions

1.6. Declaration of conformity
The albrecht GmbH company as manufacturer
with sole responsibility declares the conformity
of the MKS®Osteo flex brace with European
Council Directive 93/42/EEC for medical
devices.
1.7. Features
• Semi-elastic bandaging material
• Lateral reinforcing stays
• Firm abdominal piece with hook and loop
fastener
• Textile back piece with paravertebral steel
tape rods
• Adjustable back plate with incorporated
aluminium profile
• Reclination straps
• Individual strap course
1.8. Indications
The physician will decide on the type of
treatment to apply based on his diagnosis.
Generally the use of the MKS®Osteo flex is
indicated in:
All indications requiring an active straightening
for relief and correction of lumbar/thoracic
spine as well as limitation of movement in
sagittal plane, such as:
• Osteoporosis
• Stable, osteoporotic and traumatic vertebral
fractures
• Sintered vertebral fractures in osteporosis
• Pain caused by poor posture,
e.g. rounded shoulders
• Poor posture
• Hollow round back
• Chronic lumbago caused by hyperlordosis
• Spondylodiscitis
• Facet syndrome
• Degenerative changes in the lumbar spine
• Tumor
• Condition after intervertebral disc surgery
• Muscle insufficiency
• Abdominal muscle insufficiency
• Spondylitis
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.
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.
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User Instructions

• 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.
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 Instructions for Use. 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 orthopedics dealer.
1.14. Adjustment
The back piece of the MKS®Osteo flex
plus will be adjustet to the patient and the
indication by your orthopaedic technician. The
reclinations straps can be shortend individually.
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User Instructions

2. Putting the brace on
For those patients using the MKS®Osteo flex for the first time it is important
that they earn how to handle it. Putting it on and taking it off should be
practiced.
Wear the MKS®Osteo flex directly on the skin or over a tight-fitting singlet
without any creases. It is recommended that an absorbent singlet be worn to
avoid humidity caused by excessive sweating.
To put on the MKS®Osteo flex please follow the steps below. This will ensure
reliable effectiveness.
Always make sure that the MKS®Osteo flex is a smooth and tight fit. However,
in order to prevent constrictions along the edges it shouldn‘t be over-tightened.
1� Take the ready for use MKS®Osteo flex, previously adjusted by your
orthopaedist, out of the packaging and put it on like a backpack.
2� Close the body belt using the hand loops. Make sure that the belt fits
correctly, i.e., flat and without any creases.
3� Tighten the reclination straps by pulling them downwards and attach them
flat onto the body belt through hook and loop connections.
1 2 3
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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 MKS®Osteo flex 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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MKS®Osteo flex
User Instructions

4. Technical data
Description Material
Body Belt
elastic material 28% viskose,48% perlon, 24% elastodiene
binding 83% viscose, 17% dorlastan
velours PA
Pads velours PA
Straps velours PA
5. Choice of size
The MKS®Osteo flex is available in three sizes as per the table below.
Back piece = length from the sacrum to about 2 to 3 cm below the cervical
vertebra C 7.
6. Size chart and article numbers
Size Body circumference Abdominal height Height of back piece
S (46 cm) M (50 cm) L (56 cm)
Art.-No.: Art.-No.: Art.-No.:
1 60 - 70 cm 18 cm 783C-1 783A-1 783B-1
2 70 - 80 cm 18 cm 783C-2 783A-2 783B-2
3 80 - 90 cm 18 cm 783C-3 783A-3 783B-3
4 90 - 105 cm 18 cm 783C-4 783A-4 783B-4
5 105 - 120 cm 18 cm 783C-5 783A-5 783B-5
6 120 - 135 cm 18 cm 783C-6 783A-6 783B-6
Size Body circumference Abdominal height Height of back piece
XS (43 cm) S (46 cm) M (50 cm) L (56 cm)
Art.-No.: Art.-No.: Art.-No.: Art.-No.:
1 60 - 70 cm 14 cm 783D-1N 783C-1N 783A-1N 783B-1N
2 70 - 80 cm 14 cm 783D-2N 783C-2N 783A-2N 783B-2N
3 80 - 90 cm 14 cm 783D-3N 783C-3N 783A-3N 783B-3N
4 90 - 105 cm 14 cm 783D-4N 783C-4N 783A-4N 783B-4N
5 105 - 120 cm 14 cm 783D-5N 783C-5N 783A-5N 783B-5N
6 120 - 135 cm 14 cm 783D-6N 783C-6N 783A-6N 783B-6N
MKS
®
Osteo plus – reduced height
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User Instructions

VERSION: EN 10.2019
albrecht GmbH
CHIEMSEESTRASSE 81
D-83233 BERNAU AM CHIEMSEE / GERMANY
PHONE [phone]
FAX [phone]
[email protected]
WWW.ALBRECHTGMBH.COM