4
Warnings and Precautions
WARNING: The distal end of the socket must be NO MORE THAN ⅜ in.
(9 mm) from the upper carbon plate. The socket may be built up (through
lamination or addition of firm crepe) to achieve this distance, but failure
to do so will result in a fracture of the prosthetic foot. The distal end of
the socket must also be built sufficiently strong to resist impact of the foot
(through the Poron® pad) on the distal end. Failure to failure to follow
these instructions will cause the foot to fail and lead to falls or other
patient injuries .
CAUTION: For patient safety and device compatibility, only the appropriate
Fillauer Posterior Mounting Bracket should be used with any Fillauer
Posterior Mounted Foot .
CAUTION: Abnormal or improper environmental conditions will lead to
malfunctioning and damage of the prosthesis and is not covered under
the warranty of the device. This prosthetic/orthotic component must not
be subjected to dust/debris, liquids other than fresh water, abrasives,
vibration, activities which would damage the biological limb, or prolonged,
extreme temperatures (<-5 °C or > 50 °C). Do not allow debris or liquids
to remain in the prosthesis and its components during use. Rinse the foot
with fresh water and dry immediately after exposure.
CAUTION: The foot unit is waterproof to 1 meter. However, if the foot is
submerged, the foot and foot shell should be rinsed with fresh water and
dried immediately to remove salt, chlorine, or debris. The foot shell and
sock will experience significant deterioration if not allowed to fully dry
before return to normal use and are not covered under warranty for this
failure.
NOTICE: The foot should be inspected by the clinician every six months
for signs of abnormal wear and to assure that the attachment/alignment
screws are secure.
NOTICE: The foot stiffness is based on weight and activity level. Please
provide accurate patient information so that the appropriate foot may be
selected .
NOTICE: Attachment, alignment, and delivery of the foot must be
performed by or under the direct supervision of a qualified prosthetist.