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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 delivers optimal comfort and safety for below-knee and above-knee amputees walking on uneven ground, slopes and stairs.
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
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:
≈ 12 mm in front of the
axis of the pyramid, ± 5
mm
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 strike 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 strike 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.
C. Adjustment
The foot's response at heel strike may be modified using the elastomer wedges supplied with the device.
Depending on the stiffness of the wedge selected, the firmness of the support can be customised to the patient's requirements:
•
red= moderately stiff
•
yellow = very stiff.
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 to intense (3 or 4).
Maximum weight (including carried load): 150 kg
Designed to accommodate a heel height of 0 to 20 mm.
1/3
2/3
Heel H
from 0 to
20 mm
Knee fully
extended
Front view:
the axis passes between
the first and second toe
Axis of the connector
Vertical axis passing through
the centre of the socket at
the knee and the pyramid
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