Declaration Of Conformity - Albrecht MKS OSTEO Gebrauchsanweisung

MKS Osteo
®
User Instructions

1.6. Declaration of conformity

The albrecht GmbH company, as the
manufacturer solely responsible, declares
that the MKS Osteo
®
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 profi le
• 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
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
12 00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
brace conforms to the
MKS Osteo is
®
• Hollow round back
• Chronic lumbago caused by hyperlordosis
• Spondylodiscitis
• Facet syndrome
• Degenerative changes in the lumbar spine
• Tumor
• Condition after intervertebral disc surgery
• Muscle insuffi ciency
• Abdominal muscle insuffi ciency
• 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 verifi ed
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.