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5

INSTRUCTIONS FOR USE

INSTALLATION

When installing the Axor

™ II

 for a new patient, adhere to the following steps (each step is described in separate sec-

tions):

1. 

Connecting the prosthetic components to the Axor

™ II

2. 

Attaching the Axor

™ II

 to the Abutment (Donning)

3. 

Detaching the Axor

™ II

 from the Abutment (Doffing)

4. 

Aligning the Axor

™ II

 in the direction of walking

CONNECTING THE PROSTHETIC COMPONENTS TO THE AXOR™ II

In order to achieve the correct position of the prosthetic knee axis, the distance between the Axor

™ II

 and the pros-

thetic components must be adjusted individually depending on the length of the residual limb. If needed, use one or 
several of the OPRA

™ 

Axor

™ II

 Extension Plates (available in 5, 10 and 20 mm heights) to achieve the required height. 

Attach the prosthetic components (e.g. pyramid adaptor, prosthetic knee etc.) to the Axor

™ II

 using 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 use as long screws as possible without 
exceeding the 12mm thread depth in the Axor

™ II

.

The plug in the Axor

™ II

 front plate sits in a hole (no 4 in Figure 1) which allows for access to adjustment screws of the 

prosthetic components. Gently remove the plug from the back using a tool (e.g. screw driver).

CAUTION! 

The front plate marked with Integrum must point forward in the direction of walking to function as intended.

CAUTION! 

Check that the Axor

™ II

 does not interfere with the prosthetic components (e.g. the prosthetic knee) in 

either maximum flexion or in the fully extended position.

Содержание OPRA AXOR II

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

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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 ...

Страница 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...

Страница 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...

Страница 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...

Страница 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...

Страница 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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