This device is intended to be integrated in a custom-made external lower limb prosthesis to ensure the
function of the foot and ankle in patients with unilateral or bilateral lower limb amputation and/or
deficiencies (transtibial/transfemoral amputation, knee/hip disarticulation, congenital limb deficiencies).
This device is indicated for patients with moderate activity level (K3) for walking and low to moderate
impact activities.
Maximum weight (load carrying included): 150 kg / 330 lb (See table §3)
6.
CLINICAL BENEFITS
• Increased step length and gait symmetry
• Increased swing phase toe clearance
• Improved sitting comfort
7.
ACCESSORIES AND COMPATIBILITY
An appropriate foot shell must be installed on the foot module (refer to our catalog).
The foot includes a male pyramid connection designed to be compatible with standard female pyramid connectors (see our
catalog).
8.
ALIGNMENTS
Bench Alignment
Before fitting the prosthesis on the patient, with the foot shell
installed and a 3/8" (10 mm) lift under the heel, or preferably placed
in the desired shoe, use a plumb line or laser level to confirm that
the load line falls along the anterior edge of the pylon and pyramid
(see illustration).
Static Alignment
•
Set the hydraulic valves to highest resistance.
•
Ask the patient to stand between parallel bars with weight
evenly distributed. The patient should be able to stand
comfortably without feeling as if the knee is flexing or hyperextending. The weight line should fall along the anterior edge of
the pylon and pyramid.
If the knee is flexing, shift the foot anteriorly.
o
If the knee is hyperextending, shift the foot posteriorly.
o
Angular adjustment of the pyramid will impact the ratio of the 17 degrees range of motion. Plantarflexing at the pyramid will
decrease the dorsiflexion range of motion and dorsiflexing at the pyramid will increase the plantarflexion range of motion.
Ensure that the range of dorsiflexion and plantarflexion motion is maintained when flexion is properly accommodated. The
ankle is intended to have 2° dorsiflexion and 15° plantarflexion.
•
After at least a 10 minute acclimation period, proceed to valve resistance adjustments.
Dynamic Alignment
Adjust the hydraulic valves carefully to balance the comfort provided by the hydraulic ankle and energy return provided by the
foot module. Higher resistance will allow the carbon fiber to be loaded more and provide more energy return. Lower resistance
will allow more ankle motion and comfort while sitting and ambulating on slopes and uneven terrain.
Changes to the plantarflexion and dorsiflexion resistance settings will be most noticeable to the patient when they are walking on
slopes. Adjustments of the resistances are best done on a gradual slope as a final step in dynamic alignment.
•
Observe the patient walking between parallel bars.
•
Adjust plantarflexion resistance (P) using a 4 mm Allen wrench (see illustration below):
If there is foot slap or heel strike is too abrupt, increase plantarflexion resistance.
o
If the heel is too firm or the knee is buckling at heel strike, decrease plantarflexion resistance.
o
•
In the same way, adjust dorsiflexion resistance (D) using a 4 mm Allen wrench:
If the patient feels they are walking downhill, increase dorsiflexion resistance.
o
INSTRUCTIONS FOR USE
Caution should be used when fitting bilateral patients due to added movement of the ankle.
• Improved comfort and safety on uneven terrain
• Improved comfort and control descending ramps
• Improved knee stability
3/8''
(10 mm)
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IFU-02-005