Albrecht MKS Osteo plus Montageanleitung

USER INSTRUCTION

MKS®OSTEO /-PLUS /-FLEX /-FLEX PLUS

SPINAL ORTHOSIS

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

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.

User Instructions

www.albrechtgmbh.com 3

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

MKS®Osteo /-Plus /-Flex /-Flex Plus

User Instructions

00800 03032900 – INTERNATIONALE SERVICE-HOTLINE

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.

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.

MKS®Osteo flex MKS®Osteo flex plus MKS®Osteo flex

MKS®Osteo /-Plus /-Flex /-Flex Plus

User Instructions

00800 03032900 – INTERNATIONALE SERVICE-HOTLINE

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.

Hand wash at 30°C

Do not bleach

Do not iron

Do not dry-clean

Do not tumble dry

MKS®Osteo /-Plus /-Flex /-Flex Plus

User Instructions

00800 03032900 – INTERNATIONALE SERVICE-HOTLINE

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

www.albrechtgmbh.com 9

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

Dieses Handbuch passt für folgende Modelle

169

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