Albrecht MKS Osteo Installation instructions

USER INSTRUCTION
MKS®OSTEO
SPINAL ORTHOSIS

EN
Contents
1. Introduction .................................................................................................. 3
1.1. Foreword ................................................................................................... 3
1.2. Customer information ............................................................................. 3
1.3. Mode of operation................................................................................... 3
1.4. Application ............................................................................................... 3
1.5. Scope of delivery...................................................................................... 3
1.6. Declaration of conformity........................................................................ 4
1.7. Features..................................................................................................... 4
1.8. Indications ................................................................................................ 4
1.9. Contra-indications.................................................................................... 4
1.10. Safety Instructions.................................................................................. 4
1.11. Warranty.................................................................................................. 5
1.12. Transfer of the brace .............................................................................. 5
1.13. Disposal ................................................................................................... 5
2. Individual adjustments ............................................................................... 6
3. Cleaning, maintenance and disinfection................................................ 7
3.1. Care ........................................................................................................... 7
4. Technical data............................................................................................... 8
5. Choice of size................................................................................................ 8
6. Size chart and article numbers ................................................................. 8
MKS®Osteo
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
2

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 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 MKS®Osteo Spinal orthosis functions
according to the reclination principle. The two
shoulder straps attached to the back plate
straighten the vertebral column to relieve the
thoracic spine.
The wide lumbar bandage 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 assists treatment
in the application area from the
third thoracic vertebral body to
the fifth lumbar vertebral body in
adults. It provides stabilisation of
the entire spine. The MKS®Osteo
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 is delivered to you ready
to use in the size requested, with User
Instructions and labeling on the product.
EN
User Instructions
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1.6. Declaration of conform^wity
The albrecht GmbH company, as the
manufacturer solely responsible, declares
that the MKS®Osteo brace conforms to the
Regulation (EU) 2017/745 concerning medical
devices.
1.7. Features
• Semi-elastic bandaging material
• Lateral reinforcing stays
• Firm abdominal piece with hook and loop
fastener
• 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 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.
• The brace must not be worn over open
wounds.
EN
MKS®Osteo
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
4

• 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.
EN
User Instructions
www.albrechtgmbh.com 5

2. Individual adjustments
For those patients using the MKS®Osteo for the first time it is important that
they learn how to handle it. Putting it on and taking it off should be practiced.
Wear the MKS®Osteo 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 please follow the steps below. This will ensure
reliable effectiveness.
Always make sure that the MKS®Osteo 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, 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
1
2
2
3
3
MKS®Osteo
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
6

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 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
User Instructions
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4. Technical data
5. Choice of size
The MKS®Osteo 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
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
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 782C-1 782A-1 782B-1
2 70 - 80 cm 18 cm 782C-2 782A-2 782B-2
3 80 - 90 cm 18 cm 782C-3 782A-3 782B-3
4 90 - 105 cm 18 cm 782C-4 782A-4 782B-4
5 105 - 120 cm 18 cm 782C-5 782A-5 782B-5
6 120 - 135 cm 18 cm 782C-6 782A-6 782B-6
MKS®Osteo – reduced height
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 782D-1N 782C-1N 782A-1N 782B-1N
2 70 - 80 cm 14 cm 782D-2N 782C-2N 782A-2N 782B-2N
3 80 - 90 cm 14 cm 782D-3N 782C-3N 782A-3N 782B-3N
4 90 - 105 cm 14 cm 782D-4N 782C-4N 782A-4N 782B-4N
5 105 - 120 cm 14 cm 782D-5N 782C-5N 782A-5N 782B-5N
6 120 - 135 cm 14 cm 782D-6N 782C-6N 782A-6N 782B-6N
MKS®Osteo
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
8

Duty to report
Due to regional legal regulations, you are required to immediately report any serious incident
involving the use of this medical device to the manufacturer and the responsible authorities.
Please find our contact details on the back of this brochure.
User Instructions
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MKS®Osteo
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
10

User Instructions
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VERSION: EN 08.2022
albrecht GmbH
CHIEMSEESTRASSE 81
D-83233 BERNAU AM CHIEMSEE
T [phone]
F [phone]
[email protected]
WWW.ALBRECHTGMBH.COM
Medical device
Manufacturer
albrecht GmbH