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General conditions
This medical aid is recommended for use by one patient only. Product liability pursuant to the medical Devices Act
becomes null and void if it is used for treating more than one patient.Össur products are guaranteed 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 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 marking does not release the prosthetist from his
obligation to check as well as possible 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. weight, activity, 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 precautions for individual fittings (e.g. maintenance intervals, see Instructions for Use) must be
observed.
Combination of different fittings
• The above general conditions apply in addition to:
• Only use fittings that comply with the requirements of ISO
• Only use fittings that comply with the requirements of the medical Devices Act
• The fittings must be suitable for each other and fit the standard pyramid or mm system.
USEFUL LIFE
The maximum useful life of the Össur
OP is months.
REPLACEMENT PARTS/ACCESSORIES
No. Name Article No.
Screw for tube receiver ..
Extension stop OP Knee (new version starting with serial number xxxxx) ..
Load regulating screw OP Knee ..
Spring ..
Only the listed replacement parts and accessories are available.
To have a joint inspected please send the joint to Össur for service.
We will provide you with a service joint for the duration of the repair.
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