Useful Life - Össur Balance Knee OFM1 Instrucciones Para El Uso

held liable for the failure of his own modular components. The manufacturer can only be held liable beyond this, if
it can be proved that his modular components were causally responsible for the damage to or loss of function of
modular components from other manufacturers.
CE MARK, COMPLIANCE
All the modular components have been tested in compliance with EC Directive 93/42/EEC and bear the CE mark.
General conditions
This product is for use by one patient only. If it is used for treating more than one patient, product liability
pursuant to the medical Devices Act becomes null and void.
Össur products are guaranteed to be compatible with modular components from others, if the following points are
observed:
• The modular components are used only in compliance with their intended purpose (see relevant Instructions
for Use).
• If modular components with different max. weight limits are used, the weight limit of the weakest component
applies.
• The use of tested individual
components with the CE mark does not release the prosthetist from his obligation to check, to the best of his
capabilities, the combination of fittings for their suitability, correct assembly and safety.
• Should there be any indications that a given combination of fittings may not assure the required degree of
safety, the fittings must not be combined.
• The prostheses must be manufactured in compliance with the generally acknowledged professional rules of the
orthopaedic appliances trade.
• If the patient's suitability for wearing the prosthesis changes (e.g. body weight, mobility, etc.), the prosthesis
must be checked without delay.
• If the prosthesis has been exposed to unusually high stress, e.g. a fall, it must be inspected in a prosthetic
workshop immediately for possible damage.
• Safety-relevant regulations for individual fittings (see relevant Instructions for Use) must be observed
Combination of different modular components:
• The above general conditions apply and additionally:
• Only use modular components that comply with the requirements of ISO 10328
• Only use modular components that comply with the requirements of the medical Devices Act
• The modular components must be suitable for each other and fit the standard pyramid or 30 mm system.

USEFUL LIFE

The maximum useful life of the Össur knee joint Balance Knee OFM1/KFM1 is 36 months.
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