Intended Use; Mechanism Of Action; Explanation Of Warning Symbols; General Safety Instructions - Ottobock 8353 Genu Direxa wraparound Instrucciones De Uso

2 Intended use

2.1 Indications for use
The brace is intended exclusively for orthotic fittings of the lower limbs and exclusively for con­
tact with intact skin.
The brace must be used in accordance with the indications.
2.2 Indications
• Knee pain with mild to moderate ligament laxity and/or mild to moderate feeling of instability
• Posttraumatic and postoperative instability and/or feeling of instability
• Gonarthrosis with initial to moderate degenerative ligament instability and/or slight to moder­
ate feeling of instability (mainly involving the cruciate ligament)
• Rheumatoid arthritis
• Patellofemoral pain syndrome (e.g. chondromalacia patellae, chondropathia patellae,
retropatellar osteoarthritis)
The indication must be determined by the physician.
2.3 Contraindications
2.3.1 Absolute Contraindications
None known.
2.3.2 Relative Contraindications
The following indications require consultation with a physician: skin diseases/injuries, inflamma­
tion, prominent scars that are swollen, reddening and hyperthermia of the fitted limb/body area;
lymphatic flow disorders, including unclear soft tissue swelling distant to the body area to which
the medical device will be applied; sensory and circulatory disorders in the leg area.

2.4 Mechanism of Action

The brace improves neuromuscular function, proprioreception and circulation. It supports senso­
rimotor functions and circulation, promotes the resorption of edemas and can relieve pain.
3 Safety

3.1 Explanation of warning symbols

Warning regarding possible risks of accident or injury.
CAUTION
NOTICE Warning regarding possible technical damage.

3.2 General safety instructions

CAUTION
Contact with heat, embers or fire
Risk of injury (such as burns) and risk of product damage.
Keep the product away from open flames, embers and other sources of heat.
►
CAUTION
Reuse on other persons and improper cleaning
Skin irritation, formation of eczema or infections due to contamination with germs
► The product may be used by one person only.
► Clean the product regularly.
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