Albrecht MKS VARIO User manual

USER INSTRUCTIONS
MKS®VARIO
LUMBAR BANDAGE

L1 - L5
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
Due to its semi-elastic bandaging material the
MKS®Body Belt Vario adjusts comfortably
to the body. Through building up circular
pressure the lumbarvertebral column is
supported. The firm fastener element provides
the necessary abdominal pressure.Optionally,
blood circulation can be stimulated by
inserting the silicone pad into the integrated
back pocket.
The various possibilities of adjustment offered
by the MKS®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®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®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.
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MKS®Vario
User Instructions

1.5. Scope of delivery
The MKS®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®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
1.8. Indications
The physician will decide on the type of
treatment to apply based on his diagnosis.
Generally the use of the MKS®Vario, i.e., the
straightening and stabilisation of the lumbar
spine, is indicated in:
• Lower back pain
• Lumbago
• 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.
• 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.
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User Instructions

• 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®Vario
User Instructions

2. Individual adjustments
For those patients using the MKS®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®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®Vario please follow the steps below. This will ensure
reliable effectiveness.
Always make sure that the MKS®Vario is a smooth and tight fit.
However, in order to prevent constrictions along the edges it shouldn‘t
be over-tightened.
The MKS®Vario consists of the two lateral pieces 1 and 2, the center
piece 3 with markings 4 and the textile cover 5.
1� Depending on the girth and shape required, the two lateral pieces are
symmetrically attached to the center piece through hook and loop
connections. The embroidered markings serve as orientation. Textile
cover (5) will overlap the edges.
2� Put the MKS®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
then pull the hook and loop end of the MKS®Vario forward, so that you
can feel a slight pressure around around your waist.
4� Press the hook and loop end of the tightened MKS®Vario on the fluffy end
and flatten the MKS®Vario 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®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 manuf-
acturer. 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®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®Vario is available in two sizes as per the table below. In addition,
the function of the MKS®Vario can be extended with a supportive pad
stimulating the blood flow in the slide-in back pocket specially designed for that
purpose => MKS®Lumbago Vario.
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 581-063-S
Extra 95 - 125 cm 18 cm 25 cm 581-064-S
Silicone pad optionally available. (Art.-No.: 350-014-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