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

2 Application
2.1 Intended Use
The orthosis is intended exclusively for orthotic fittings of the lower limbs and exclusively for
contact with intact skin.
The orthosis 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, retropa­
tellar osteoarthritis)
Indications must be determined by the physician.
2.3 Contraindications
2.3.1 Absolute Contraindications
Not 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 Effects
The orthosis improves neuromuscular function, proprioreception and circulation. It supports sen­
sorimotor functions and circulation, promotes the resorption of oedemas and can relieve pain.
3 Safety

3.1 Explanation of Warning Symbols

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

3.2 General Safety Instructions

CAUTION
Using the product without following the instructions for use
Deteriorating health condition and damage to the product because of failure to follow the safety
information
► Observe the safety information in these instructions for use.
Make the patient aware of all safety instructions marked with "Inform the patient".
►
CAUTION
Contact with heat, embers or fire
Injuries (e.g. burns) caused by melting of the material
► Keep the product away from open flame, embers and other sources of heat.
Inform the patient.
►
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