Declaration Of Conformity; Features; Indications; Contra Indications - Albrecht MKS EXTENSA PLUS Gebrauchsanweisung

MKS Extensa plus
®
User Instructions

1.6. Declaration of conformity

The albrecht GmbH company, as the
manufacturer solely responsible, declares that
the MKS Extensa plus
®
Regulation (EU) 2017/745 concerning medical
devices.

1.7. Features

• Adjustable, stable aluminium profi les
• Padded pelottes
• Individual strap course
• Compression padding for the waist
• Adjustable, fi rm back plate
• Clip fastener for easy handling
Optionally, a gluteal brace can be used for
further limitation of the lateral flexion.

1.8. Indications

The physician will decide on the type of
treatment to apply based on his diagnosis.
Generally the use of the
i.e., partial relief to the lumbar-/thoracic spine
(limitation of movement in sagittal plane) is
indicated in:
All Indications requiring a partial relief by
correction of lumbar/thoracic spine, such as:
• Stable vertebral body fractures
For all other indications a physician must be
consulted.
12 00800 03032900 – INTERNATIONAL SERVICE-HOTLINE
brace conforms to the
MKS Extensa plus,
®

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.
• 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 fi t fi rmly 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.