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5.
INTENDED USE/INDICATIONS
These medical devices are supplied to healthcare professionals (prosthetists), who will train the patient in their use.
The prescription is drawn up by a doctor who assess the patient's ability to use the device.
These devices are for multiple use on a SINGLE PATIENT. They must not be used on another patient.
6.
CLINICAL BENEFITS
• Walking comfort
• Reduction of joint impacts
7.
ACCESSORIES AND COMPATIBILITY
An appropriate foot shell must be mounted on the foot module (refer to our catalogue).
The foot includes a male pyramid connection designed to be compatible with standard female pyramid connectors (see our
catalogue).
8.
ALIGNMENTS
Bench alignment
Before installing the prosthesis on the patient:
•
Align the foot module in plantar/dorsal flexion, by inserting
the foot (with foot shell) into the shoe to account for the
heel height
•
Align the socket in adduction/abduction, to ensure an
appropriate angle in the frontal plane
•
Align the socket in flexion/extension, to ensure an appropriate
angle in the sagittal plane
•
Adjust the position of the socket so that the load line falls to
the anterior dome of the pyramid (see illustrations)
Dynamic alignment
To optimize roll-over from heel to forefoot, adjust the following variables:
•
Foot position in the anterior/posterior plane
•
Plantar/dorsal flexion
•
Heel flexibility
The dynamic alignment is performed in accordance with good professional practices.
9.
ASSEMBLY
The Pacifica is pre-assembled and consists of a foot module, a Spectra sock, and a foot shell. After dynamic alignment, tighten the
pyramid adjustment screws according to the specifications of the connector manufacturer. Secure pyramid adjustment screws
with a thread locking adhesive (i.e., Loctite 242).
Spectra® sock
A Spectra sock is included to protect the foot shell and minimize noise. It must be placed on the foot module before mounting the
foot shell.
Foot shell
To install and remove the foot shell, use the foot shell removal tool to prevent damage of the foot module.
Never remove the foot from the foot shell by pulling manually. This could damage the foot.
The Pacifica is intended to be integrated in a custom-made external lower limb prosthesis to ensure
the function of the foot in patients with unilateral or bilateral lower limb amputation and/or congenital
limb deficiency. The Pacifica is particularly suitable for patients with a long residual limb.
This device is indicated for patients with moderate activity level (K3) for walking and physical activities
without excessive overload.
Maximum weight (load carrying included): 166 kg / 365 lbs (See table §3)
INSTRUCTIONS FOR USE
• Stability on variable terrain
• Possible walking on uneven ground
Load line
Load line
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IFU-01-011
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