INSTRUCTIONS FOR USE
10
WARNINGS
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In configurations where short extension components are used between the Axor™ II and the prosthetic knee, the
battery charger of certain prosthetic knee models (e.g. Otto Bock C-leg) may interfere with the Axor™ II when
the knee is in the straight position. In these cases, please advise the patient to bend the knee to connect the
charger.
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If the Axor™ II does not release as intended, e.g. during overload, or releases unexpectedly, the responsible pros-
thetist must be contacted and the Axor™ II must be checked.
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If the Axor™II is not detachable from the Abutment or locked in a resting position, the responsible prosthetist
must be contacted and the Axor™ II must be checked.
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The use of stiff cosmetic covers may interfere with the function of the Axor™ II.
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Prosthetic components with internal power supply attached to the Axor™ II must comply with the standard
IEC60601 for medical electrical equipment.
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Poor cleaning can cause the Axor™ II to fall off the Abutment or damage the release function. It could also cause
infection or cross contamination between patient and personnel.
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If you are having an MRI scan, you must always remove the Axor™ II. Failure to do so may result in serious injury.
PATIENT EDUCATION
The patient must receive the leaflet OPRA™ Axor™ II - Patient Information.
The following information must be emphasised to the patient:
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How to recognise when the Axor™ II has released in bending/flexion or rotation.
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How to reset the Axor™ II following its release in bending/flexion or rotation.
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The Axor™ II is not intended for use with the following physical activities:
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Do not run, jump or climb.
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It is recommended to use a cane or crutches for long walks.
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Do not lift or carry heavy items.
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Avoid subjecting the OPRA™ Implant System to high torque (twisting motion or bending).
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While riding a bike, your knee joint might lock in the fully stretched position. This can seriously damage the
Fixture. Always position the bike seat low enough that your knee cannot fully extend while cycling. Never
stand up while you are cycling. Consult with your treating team before riding a bike for the first time.
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Handrails and/or other supports should be used when walking downstairs.
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If the Axor™ II does not release as intended, e.g. during overload, or releases unexpectedly, the responsible pros-
thetist must be contacted and the Axor™ II must be checked.
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Cleaning of the Axor™ II must be carried out according to the instructions.
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If the Axor™ II has been submerged in water, the patient should contact the prosthetist who should verify the
function of the Axor™ II.
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The Axor™ II must be checked in the event of any damage.
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If any sound, vibration or feeling of movement occurs between the Axor™ II and the Abutment, the responsible
prosthetist must be contacted.
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The patient should never try to open the Axor™ II or release any of the screws.
