Otto Bock 28R16, Instructions For Use Manual

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9
►
Please contact the manufacturer if you have questions about the product or in case of prob­
lems.
►
Report each serious incident in connection with the product, in particular a worsening of the
state of health, to the manufacturer and to the relevant authority in your country.
► Please keep this document for your records.
These instructions for use provide important information on the fitting and application of the
28R16 hyperextension brace.
2 Product description
2.1 Components
Scope of delivery (see Fig. 1)
Item
Component
1 Sternal support
2 Side element
3 Locking lever
4 Waist strap
5 Pelvic band
6 Back support
7 Padding set
2.2 Design
The hyperextension brace is supplied as a component kit. The sternal support that is part of the
anterior frame structure, the side elements, and the pelvic band are padded with Evazote foam.
The sternal support has a small pivoting mount so it automatically adapts to the required angle.
The back support is attached to the frame structure using the waist strap. The locking lever
enables easy application and removal of the brace.
3 Intended use
3.1 Indications for use
The brace is intended exclusively for orthotic fittings of the back and exclusively for contact with
intact skin.
The brace must be used in accordance with the indications.
3.2 Indications
• Stable fractures of the thoracolumbar transition (T10 to L2) without neurological damage
The indication must be determined by the physician.
3.3 Contraindications
3.3.1 Absolute Contraindications
None known.
3.3.2 Relative Contraindications
The following conditions require consultation with a physician: skin diseases/injuries, inflamma­
tion, raised scars with swelling, reddening, and warming in the area where the support is fitted,
tumors, lymphatic congestion – including unclear soft tissue swelling distal to the support, and
dysesthesia in the trunk.