Albrecht MKS LUMBAGO VARIO User manual

USER INSTRUCTIONS
MKS®LUMBAGO VARIO
LUMBAR BANDAGE
WITH SILICONE PAD STIMULATING BLOOD CIRCULATION

1. Introduction
1.1. Introduction
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
Through building up circular pressure the
lumbar vertebral column is supported. The
firm fastener element provides the necessary
abdominal pressure which can be enhanced
through the additional tensioning straps. The
inserted silicone pad in the integrated back
pocket stimulates blood circulation.
The various possibilities of adjustment offered
by the MKS®Lumbago Vario allow the
construction of lumbar bandages of different
girths and shapes.
Only two sizes are needed to cover a range of
girths from 70cm to 125cm: Vario Standard
(70-95cm) and Vario Extra (95-125cm).
1.4. Application
The brace must only be used for the orthotic
treatment of the vertebral column.
The MKS®Lumbago
Vario assists treatment
in the application area
from the first to the
fifth lumbar vertebral
body in adults. It
provides stabilization
of the entire spine. The
MKS®Lumbago Vario
is intended to help
you achieve a lifestyle
that is as independent
as possible while still
meeting your needs and
matching your personal
capabilities.
L1 - L5
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User Instructions

1.5. Scope of delivery
The MKS®Lumbago Vario is delivered to you
ready for use, in the size you ordered, with
User Instructions and labeling on the product.
1.6. Declaration of conformity
The albrecht GmbH company as manufacturer
with sole responsibility declares the conformity
of the MKS®Lumbago Vario 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
• Back pocket suitable for silicone
pad stimulating blood circulation or
MKS®Osteo back plate
• Circumference and shape can be adjusted
• Silicone pad stimulating blood circulation
1.8. Indications
Your physician will decide on the type of
treatment to apply based on his diagnosis.
Generally the use of the MKS®Lumbago Vario,
i.e., the straightening and stabilization of the
lumbar spine, is indicated in:
• Severe lower back pain
• Severe lumbago
• Relapsing lumbago
• Osteochondrosis
• Spondylolysis without displacement
of vertebrae
• Mild lumbar deformity (with displacement
of vertebrae)
• Spondylarthrosis
• Sacroilliac joint irritation
• Lumbar muscle insufficiency
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.
• The skin should be free of oils, grease, gels
or other debris, to prevent reactions with the
skin or the structure of the material.
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User Instructions

• 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.
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MKS®Lumbago Vario
User Instructions

2. Individual adjustments
For those patients using the MKS®Lumbago Vario for the first time it is
important to learn how to handle it.
Putting it on and taking it off should be practiced. Wear the MKS®Lumbago
Vario 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®Lumbago Vario please follow the steps below. This will
ensure reliable effectiveness. Always make sure that the MKS®Lumbago Vario
is a smooth and tight fit. However, in order to prevent constrictions along the
edges it shouldn‘t be over-tightened.
The MKS®Lumbago Vario consists of the two lateral pieces 1 and 2,
the center piece 3 with markings 4, the textile cover 5 and the supportive
pad 6. Depending on the girth and shape required, the two lateral pieces
are symmetrically attached through hook and loop connection to the
center piece. The embroidered markings serve as orientation.
1� Insert the supportive pad into the slide-in back pocket specially designed for
that purpose. The textile cover (5) will overlap the edges.
2� Put the MKS®Lumbago Vario around your waist from the back to the front
making sure that the dark slide-in pocket rests inside against your back.
3� Press the band with the fleece on the front down on your stomach and pull
the hook and loop fastener of the MKS®Lumbago Vario forward so that you
can feel a slight pressure around your waist.
4� Now press the hook and loop fastener of the tightened MKS®Lumbago Vario
on the fluffy end and flatten down the MKS®Lumbago Vario brace with your
hand.
1 2 3 4
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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®Lumbago Vario 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®Lumbago Vario
User Instructions

4. Technical data
Description Material
Body Belt
elastic material 28% viscose, 48% perlon, 24% elastodiene
binding 83% viscose, 17% dorlastan
velours PA
5. Choice of size
The MKS®Lumbago Vario is available in two sizes as per the table below. The
MKS®Lumbago Vario is supplied with a supportive pad in the slide-in back
pocket stimulating the blood flow. If necessary, the pad can be removed.
6. Size chart and article numbers
Name Body
circumference
Abdominal
height
Height
of back piece Art.-No.
Standard 70 - 95 cm 18 cm 25 cm 581-069-S
Extra 95 - 125 cm 18 cm 25 cm 581-070-S
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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