Albrecht MKS Osteo Montageanleitung

USER INSTRUCTION

MKS®OSTEO

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...................................................................................... 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

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.

User Instructions

www.albrechtgmbh.com 3

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.

MKS®Osteo

User Instructions

00800 03032900 – INTERNATIONALE SERVICE-HOTLINE

• 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.

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.

MKS®Osteo

User Instructions

00800 03032900 – INTERNATIONALE SERVICE-HOTLINE

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.

Hand wash at 30°C

Do not bleach

Do not iron

Do not dry-clean

Do not tumble dry

User Instructions

www.albrechtgmbh.com 7

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

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

www.albrechtgmbh.com 9

MKS®Osteo

User Instructions

00800 03032900 – INTERNATIONALE SERVICE-HOTLINE

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