Albrecht MKS Osteo plus Installation instructions

USER INSTRUCTION
MKS®OSTEO /-PLUS /-FLEX /-FLEX PLUS
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 ...............................................................................4
1.6. Declaration of conformwity ............................................................... 4
1.7. Features .............................................................................................4
1.8. Indications.........................................................................................4
1.9. Contra-indications ............................................................................. 5
1.10. Safety Instructions ........................................................................... 5
1.11. Warranty .......................................................................................... 5
2. Individual adjustments.........................................................................6
3. Cleaning, maintenance and disinfection ............................................8
4. Technical data .......................................................................................9
5. Size chart and article numbers ............................................................9
6. Transfer to the brace .......................................................................... 13
7. Disp osal ................................................................................................ 13
MKS®Osteo /-Plus /-Flex /-Flex Plus
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 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 instructions.
1.3. Mode of operation
The MKS®Osteo and MKS®Osteo flex 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 reclination straps are attached to the
lumbar bandage through additional lateral
straps.
Hereby rotation is limited and stabilisation is
ensured.
The wide lumbar bandage straightens and
hence relieves the lumbar vertebral column.
MKS®Osteo plus and MKS®Osteo flex plus
with additional tensioning straps
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.
EN
User Instructions
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1.5. Scope of delivery
The MKS®Osteo is delivered to you ready
for use, in the size you ordered, with User
Instructions and labeling on the product.
1.6. Declaration of conformwity
The albrecht GmbH company as manufacturer
with sole responsibility declares the conformity
of the MKS®Osteo brace with European
Council Directive 93/42/EEC for medical
devices.
1.7. Features
MKS®Osteo
• 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
MKS®Osteo plus
+Additional tensioning straps
MKS®Osteo flex
+Textile back piece with paravertebral steel
tape rods
MKS®Osteo flex plus
+Additional tensioning straps
+Textile back piece with paravertebral steel
tape rods
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
EN
MKS®Osteo /-Plus /-Flex /-Flex Plus
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
4

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 onlyachieved
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.
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
o 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.
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 orthosis 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 it please follow the steps below. This will ensure reliable effectiveness.
Always make sure that it is 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 flex MKS®Osteo flex plus MKS®Osteo flex
MKS®Osteo /-Plus /-Flex /-Flex Plus
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
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Additional strap for MKS®Osteo plus and MKS®Osteo flex plus:
Tighten the additional strap by pulling it forward and attach it flat onto the body belt through
hook and loop connections.
MKS®Osteo plus
User Instructions
www.albrechtgmbh.com 7

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.
• 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
MKS®Osteo /-Plus /-Flex /-Flex Plus
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
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4. Technical data
5. 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
MKS®Osteo
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
User Instructions
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MKS®Osteo Plus
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 784C-1 784A-1 784B-1
2 70 - 80 cm 18 cm 784C-2 784A-2 784B-2
3 80 - 90 cm 18 cm 784C-3 784A-3 784B-3
4 90 - 105 cm 18 cm 784C-4 784A-4 784B-4
5 105 - 120 cm 18 cm 784C-5 784A-5 784B-5
6 120 - 135 cm 18 cm 784C-6 784A-6 784B-6
MKS®Osteo Plus – 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 784D-1N 784C-1N 784A-1N 784B-1N
2 70 - 80 cm 14 cm 784D-2N 784C-2N 784A-2N 784B-2N
3 80 - 90 cm 14 cm 784D-3N 784C-3N 784A-3N 784B-3N
4 90 - 105 cm 14 cm 784D-4N 784C-4N 784A-4N 784B-4N
5 105 - 120 cm 14 cm 784D-5N 784C-5N 784A-5N 784B-5N
6 120 - 135 cm 14 cm 784D-6N 784C-6N 784A-6N 784B-6N
MKS®Osteo /-Plus /-Flex /-Flex Plus
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
10

MKS®Osteo Flex
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
MKS®Osteo Flex – 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 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
User Instructions
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MKS®Osteo Flex Plus
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 781C-1 781A-1 781B-1
2 70 - 80 cm 18 cm 781C-2 781A-2 781B-2
3 80 - 90 cm 18 cm 781C-3 781A-3 781B-3
4 90 - 105 cm 18 cm 781C-4 781A-4 781B-4
5 105 - 120 cm 18 cm 781C-5 781A-5 781B-5
6 120 - 135 cm 18 cm 781C-6 781A-6 781B-6
MKS®Osteo Flex Plus – 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 781D-1N 781C-1N 781A-1N 781B-1N
2 70 - 80 cm 14 cm 781D-2N 781C-2N 781A-2N 781B-2N
3 80 - 90 cm 14 cm 781D-3N 781C-3N 781A-3N 781B-3N
4 90 - 105 cm 14 cm 781D-4N 781C-4N 781A-4N 781B-4N
5 105 - 120 cm 14 cm 781D-5N 781C-5N 781A-5N 781B-5N
6 120 - 135 cm 14 cm 781D-6N 781C-6N 781A-6N 781B-6N
MKS®Osteo /-Plus /-Flex /-Flex Plus
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
12

6. Transfer to 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.
7. 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.
User Instructions
www.albrechtgmbh.com 13

MKS®Osteo /-Plus /-Flex /-Flex Plus
User Instructions
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
14

User Instructions
www.albrechtgmbh.com 15

VERSION: EN 09.2022
albrecht GmbH
CHIEMSEESTRASSE 81
D-83233 BERNAU AM CHIEMSEE
T [phone]
F [phone]
[email protected]
WWW.ALBRECHTGMBH.COM
Medical device
Manufacturer
albrecht GmbH