Product Description; Intended Use; Explanation Of Warning Symbols - Ottobock 50K30 Xeleton Instrucciones De Uso

Please read this document carefully before using the product and observe the safety
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notices.
Instruct the user in the safe use of the product.
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Please contact the manufacturer if you have questions about the product or in case of prob­
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lems.
Report each serious incident in connection with the product, in particular a worsening of the
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state of health, to the manufacturer and to the relevant authority in your country.
Please keep this document for your records.
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These instructions for use provide important information on the fitting and application of the
50K30 Xeleton knee joint orthosis.

2 Product description

Item Component (see fig. 1)
A Joint cover
B Pad retainer
C Technogel® condyle pad

3 Intended use

3.1 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.
3.2 Indications
• After ruptures of the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL),
collateral ligament injuries (MCL, LCL) or after capsular ligament surgery
• Conservative, pre-operative and post-operative joint stabilisation (e.g. after meniscal fixation
or meniscus replacement) with limited range of motion
• Conservative therapy of chronic complex knee joint instability
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 indications require consultation with a physician: skin diseases/injuries; inflamma­
tion; prominent, swollen scars; reddening and hyperthermia of the treated limb; pronounced vari­
cose veins, especially with impaired return flow; lymphatic flow disorders, including unclear soft
tissue swelling distal to the body area where the device will be applied; sensory and circulatory
disorders in the legs, e. g. associated with diabetic neuropathy.
3.4 Mechanism of Action
The brace relieves and stabilises the knee joint.
4 Safety

4.1 Explanation of warning symbols

Warning regarding possible risks of accident or injury.
CAUTION
Item Component (see fig. 1)
D Pull loop
E Tibia pad
F Screw connection
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