Össur OP4 KNEE Instructions For Use Manual

Contents

10General conditionsThis medical aid is recommended for use by one patient only. Product liability pursuant to the medical Devices Actbecomes null and void if it is used for treating more than one patient.Össur products are guaranteed compatiblewith 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 componentapplies.• The use of tested individual components with the CE marking does not release the prosthetist from hisobligation to check as well as possible the combination of fittings for their suitability, correct assembly andsafety.• Should there be any indications that a given combination of fittings may not assure the required degree ofsafety, the fittings must not be combined.• The prostheses must be manufactured in compliance with the generally acknowledged professional rules of theorthopaedic appliances trade.• If the patient’s suitability for wearing the prosthesis changes (e.g. weight, activity, etc.) the prosthesis must bechecked without delay.• If the prosthesis has been exposed to unusually high stress, e.g. a fall, it must be inspected in a prostheticworkshop immediately for possible damage.• Safety-relevant precautions for individual fittings (e.g. maintenance intervals, see Instructions for Use) must beobserved.Combination of different f ittings• The above general conditions apply in addition to:• Only use fittings that comply with the requirements of ISO 10328• 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 30 mm system.USEFUL LIFEThe maximum useful life of the ÖssurOP4 is 36 months.REPLACEMENT PARTS/ACCESSORIESNo. Name Article No.7 Screw for tube receiver 1.970.95212 Extension stop OP4 Knee (new version starting with serial number 0712xxxxx) 1.970.95413 Load regulating screw OP4 Knee 1.970.95314 Spring 1.970.951Only 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.