3. INTENDED USERS/INDICATIONS
This medical device is supplied to healthcare professionals (prosthetists/orthotists) who then instruct the patient in how to use it. The
prescription is drawn up by a doctor. The doctor works with a prosthetist/orthotist to assess whether the patient is suited to using the device.
This device should be used on ONE PATIENT ONLY. It must not be reused on other patients.
4. CLINICAL BENEFITS
The device provides optimal stability and flexibility for below-knee and above-knee amputees walking on smooth or uneven ground.
5. ACCESSORIES AND COMPATIBILITIES
The foot incorporates a male pyramid link that allows it to be used with female pyramid connectors (refer to our catalogue).
The heel height can be adjusted from 0 to 20 mm.
6. ASSEMBLY AND FITTING TO THE PATIENT
A. Assembly
Bonding the stop:
Remove the foot from the foot shell and then remove the sock.
Degrease the surfaces to be bonded, leave to dry and then apply epoxy adhesive to both faces.
Bring the stop into contact with the nut (1), then fit it by pushing upwards (2) and towards the nut (3).
Leave to dry, then refit the sock and the foot shell.
Assembly:
Place a block under the foot whose thickness corresponds to the height of the shoe's heel.
Secure the female pyramid connector to the foot, positioning its axis perpendicular to the ground.
Tighten the connector's screws to the specified tightening torque.
B. Aligning
Align the device such that the load line passes through the posterior of the foot, 1/3rd of the length from the back.
Centre of coxofemoral
joint
Centre of knee joint
Load line:
≈ 15 mm in front of the
axis of the pyramid
•
For a more dynamic alignment, increasing the plantar flexion improves the energy return at step completion.
•
If, during roll-over, the patient feels that their foot is too long, or if the heel contact is too soft, the foot should be moved in the
posterior direction with respect to the socket.
•
If, during roll-over, the patient feels that their foot is too short, or if the heel contact is too rigid, the foot should be moved in the
anterior direction with respect to the socket.
The dynamic alignment is performed in accordance with good professional practices.
INSTRUCTIONS FOR USE
This device is exclusively intended to be used as orthopaedic equipment for a below-knee or above-knee
amputee whose activity level is normal or high (3 or 4).
Maximum weight (including carried load): 125 kg
Designed to accommodate a heel height of 0 to 20 mm.
Knee fully
extended
1/3
2/3
Vertical axis passing
through the centre of the
socket at the knee and the
pyramid
Page 2 of 4
Heel H
Front view:
the axis passes between
the first and second toe