Declaration Of Conformity; Features; Indications; Contra Indications - Albrecht MKS THORECTA PLUS Manuel D'utilisation

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MKS
Thorecta plus
®
User Instructions

1.6. Declaration of conformity

The albrecht GmbH company, as the
manufacturer solely responsible, declares that
the
MKS
®
Thorecta 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
Additional fi rm thorax support
Reclination straps
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., relief and/or correction of lumbar/thoracic
spine in sagittal and frontal plane with functional
mobilisation is indicated in:
All indications requiring a relief and/or correction
of lumbar/thoracic spine as well as limitation
of movement in sagittal and frontal plane with
following functional mobilisation, such as:
Stable vertebral body fractures
Scheuermann's disease
Postsurgical stabilisation
Tumor
Spondylitis
12
00800 03032900 – INTERNATIONALE SERVICE-HOTLINE
brace conforms to the
MKS
®
Thorecta
plus,
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.
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.

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Mks thorecta

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