Streifeneder LumboVario.tec Instructions For Use

Application (Don- and doffing)
„
The product must be worn on a T-shirt.
Put the orthosis around the upper body in such a way, that the outer pockets on the knitted
part for the PA-bars and corset bars are positioned parallel to the spine and the label is on the
top. The anatomically shaped back shell must be placed by an orthopaedic technician, and
the pre-shaped pelvic indentations must be aligned evenly on the iliac crests (Fig. 1).
Then close the orthosis by means of the knitted part. To do this, push your fingers into the
loops (Fig. 2) and press the left closing-part in central position on the abdomen. Now fasten
the right closing-part, covering the lower part as evenly as possible, by means of the hook- and
loop fasteners. While fastening, pull your fingers out of the left and then out of the right loop
(Fig. 3).
If the intraabdominal pressure shall be increased, the included abdominal pad should be
placed centred on the left closing-part in direction of the body (Fig. 4).
The tension belts must be pulled backwards at the same time, until the requested tension has
been achieved and are fastened by hook- and loop onto the knitted part (Fig. 5).
In order to achieve optimal tension even for the long type, first the bottom-, then the upper
tension belts must be closed (Fig. 6).
During closing the knitted part, make sure that the orthosis remains in correct position and
will not slip in any direction.
The knitted bandage without back shell must be positioned the same way, as described
above. Also, the knitted part must be placed correctly with the label on top (Fig. 7).
To insert the PA-bars (Fig. 8) and corset bars (Fig. 9) into the knitted part, open the designated
pockets.
To remove the PA-bars and the corset bars from the knitted part, simply pull them out of their
pockets. To insert the PA-bars and corset bars into the knitted part (e.g. after washing), open
the pockets and insert the bars according to the principal marks (top, bottom).
Correct positioning of the orthosis should be trained with the help of an orthopaedic
technician or qualified personnel.
Loosen the orthosis by removing the tension belts from the knitted part and then fasten it again
without tension.
Now pull both closure-parts apart until they have separated completely.
Take the orthosis off and in order to protect the closure, fix both closure-parts with the hook-
and loop fasteners.
In order to benefit an optimal therapy process, the plastic shell must be adapted individually
to the user. Pressure points must be avoided, resp. be removed by corresponding adjustments
done by the orthopaedic technician. For this purpose, the plastic shell as well as the PA-bars
may be thermoformed.
In addition to the individual adaptation of the plastic shell, wedges can be cut out from the
side- and rear edges.
The optimal thermoforming temperature of 80 °C has been achieved as soon as the heated
plastic has a matt surface. For thermoforming, it is best to use the hot-air gun.
Please keep in mind that excess punctual heating may permanently damage the material. In this
case, we cannot grant any product liability. Therefore, watch the heat output of your hot-air
gun.
If the product is used after spinal fusions (spondylodesis), the PA-bars must be
adapted to the anatomical course of the spinal column! Otherwise,a delordosation
could endanger surgery result as well as therapy goal.
If the product is used to bypass the lordosis, the PA-bars must be inserted with the convex side
showing to the outside. If contouring irons are used, only contouring irons with round edges must
be used!
The correct position of the orthosis must be re-checked after each adaptation while the user
is sitting as well as standing. Local pressure peaks must be prevented in the entire orthosis
range.
„ Care Instructions
• remove the plastic shell as well as the stabilisation bars from the knitted part.
Knitted part:
• close the hook- and loop-fasteners before washing
• machine wash at 30 °C on a gentle cycle
• do not chemically clean, or bleach with chlorine, or iron the product
• do not dry on a radiator
Plastic shell:
• clean the product with a damp cloth and mild soap
To reinsert the stabilisation bars into the knitted part, obey the direction, the arrow must
point to the top. Furthermore, the plastic shell has an arrow underneath the holes, which also
points to the top. The label at the knitted part is attached on top, the arrows of the hook-
and loop fasteners point to the top.
„ Declaration of Conformity
Streifeneder ortho.production GmbH declares as manufacturer with sole responsibility that
the product complies with Regulation (EU) 2017/745 for medical devices (MDR).
LumboVario.tec
30R1/... 35R1/...
Instructions for use
ortho production