1.6. Declaration of conformity
The albrecht GmbH company as manufacturer
with sole responsibility declares the conformity
of the
MKS
®
Osteo flex
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
•
Textile back piece with paravertebral steel
tape rods
•
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 flex
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.
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3
User Instructions