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OPRA™ AXOR™ II

Instructions For Use

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Summary of Contents for OPRA AXOR II

Page 1: ...OPRA AXOR II Instructions For Use ...

Page 2: ...MPONENTS TO THE AXOR II 5 ATTACHING THE AXOR II TO THE ABUTMENT DONNING 6 DETACHING THE AXOR II FROM THE ABUTMENT DOFFING 7 ALIGNING THE AXOR II IN THE DIRECTION OF WALKING 7 RELEASE FEATURES 7 RESETTING THE AXOR II AFTER RELEASE IN BENDING FLEXION 8 RESETTING THE AXOR II AFTER RELEASE IN ROTATION 8 CLEANING AND HYGIENE INSTRUCTIONS 9 MAINTENANCE 9 PATIENT EDUCATION 10 WARNINGS 10 APPENDIX 1 LABEL...

Page 3: ...European 4 hole male female mounting system is utilized in the external prosthetic device This allows the OPRA system to be connected to all prosthetic systems that utilize this standardized connection method The OPRA System is recommended for use with commercially available non micro processor controlled prosthetic knees and microprocessor controlled prosthetic knees that do not include powered a...

Page 4: ...nt 3 Alignment nuts 4 Plug for adjustment screw access 5 Prosthetic connection area with the 4 hole configuration For label specification please see Appendix 1 Figure 1 Product description Factory setting of torque release level 15 2 Nm Factory setting of bend release level 70 5 Nm Building height marked in Figure 1 52 mm Total height marked in Figure 1 76 mm Weight of the device 0 8 kg ...

Page 5: ...tic components e g pyramid adaptor prosthetic knee etc to the Axor IIusing standard techniques and in accordance with the manufacturer s instructions for the prosthetic component s Use M6 screws to connect the prosthetic components to the 4 hole configuration at the bottom of the Axor II no 5 in Figure 1 The length of the screws depends on the prosthetic components used but it is recommended to us...

Page 6: ...the Abutment can enter the Axor II see Figure 2 3 Insert the Abutment while keeping the Axor II open Make sure that the Abutment contacts the bottom of the jaws see Figure 3 4 Release the grip and let it rotate freely Tighten the grip clockwise by hand 5 Move the leg side to side and tighten the grip further by hand to make sure it is firmly attached to the Abutment 6 Try to pull off the Axor II t...

Page 7: ...ection of walking according to the following steps 1 Untighten the two alignment nuts no 3 in Figure 1 maximum half a turn CAUTION Untightening the alignment nuts more than half a turn may damage the Axor II 2 Rotate the Axor II until it is aligned in the direction of walking 3 Tighten the two alignment nuts with a torque of 5 Nm to lock the position of the prosthesis RELEASE FEATURES The Axor II ...

Page 8: ...y pain during the reset procedure In case of pain please contact your physician immediately Please also contact your prosthetist for reset of the Axor II CAUTION Try to keep fingers away from the bend release mechanism during reset to avoid pinching the fingers RESETTING THE AXOR II AFTER RE LEASE IN ROTATION When the Axor II has released in rotation it is reset by turning the Axor II until the pr...

Page 9: ...I can cause the Axor II to fall off the Abutment or damage the release function CAUTION If the device is not clean the risk for infection is increased Body fluids from the skin penetration area should not reach the Axor II A protective tissue tied around the Abutment should preferably be used Patient usage and cleaning recommendation can also be found in our instructional video on Integrum s websi...

Page 10: ... information must be emphasised to the patient How to recognise when the Axor II has released in bending flexion or rotation How to reset the Axor II following its release in bending flexion or rotation The Axor II is not intended for use with the following physical activities Do not run jump or climb It is recommended to use a cane or crutches for long walks Do not lift or carry heavy items Avoid...

Page 11: ... must not be copied shown or passed on to third parties without the company s written consent Prosthetic components with internal power supply attached to the Axor must comply with the standard IEC60601 for medical electrical equipment Poor cleaning can cause the Axor to fall off or damage the release function It could also cause infection or cross contamination between patient and personnel Appen...

Page 12: ...21 10 Krokslätts Fabriker 50 SE 431 37 Mölndal Sweden PHONE 46 0 31 760 10 60 EMAIL info integrum se WEBSITE www integrum se 100 Montgomery Street Suite 1780 San Francisco CA 94104 USA PHONE 1 800 805 8073 EMAIL info US integrum se WEBSITE www integrum se ...

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