Fillauer Element Bedienungsanleitung
Element
Product Manual
3
Contents
Intended Use...................................................4
Warnings and Precautions .......................................5
Alignment (Specications & PreparationsBefore Use)................6
Consumable Components: Foot Shell and Spectra®Sock .............8
Compatibility ...................................................9
Disposal/ Waste Handling ......................................10
Warranty .....................................................10
User Instructions ..............................................10
Serious Incidents ..............................................11
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Intended Use
The Element prosthetic foot is intended for use in lower extremity
prostheses. The Element sets itself apart from other low-prole, two-
spring prosthetic foot designs by adding an innovative 3rd Element.
Fillauer has designed the Element to support each phase of foot
function in the gait cycle—from heel strike to midstance and midstance
to toe o. The result is a foot with unsurpassed smoothness, stability
and performance throughout the gait cycle.
Lower Foot
Plate
Upper Spring
Element 3rd Element
Figure 1
Indications
• Moderate to active transtibial or transfemoral amputees as dened
by functional K3 activity levels
• Unilateral or bilateral patients
• Patients that would benet from increased exibility and smooth
rollover
• Patients weighing up to 300 lbs. (136 kg)
Contraindications
• Clearance below 3.75 in. (9.5 cm)
• Patients weighing over 300 lbs. (136 kg)
• Patients wanting to run or jog regularly on the device
The device is intended for single user/patient use only.
Performance Characteristics
• Patient weight: Up to 300 lbs. (136 kg)
• Foot weight: 12 oz. (340 g)
• Build height: 3.75 in. (9.5 cm)
• Functional level: K3
• Durable; meets ISO-22675 standard
• Primary Materials: Carbon composite, stainless steel, titanium, and
aluminum
• Waterproof: The foot unit is waterproof to 1 meter. See additional
information below.
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Storage and Handling
It is recommended that prosthetic feet be stored in a cool, clean, dry
environment away from harsh chemicals (chlorine, acids, acetone, etc.).
Warnings and Precautions
CAUTION: The Element is designed to be maintenance free
and should not be disassembled. The pyramid dome on the
foot is permanently attached to the pylon (main and top)
spring and should not be removed.
CAUTION: Fillauer has tested (ISO 10328) and recommends
the use of standard, adult, endoskeletal components from
Fillauer with all Fillauer feet. Components from other
manufacturers may or may not be compatible. Failure due
to use of other manufacturers’ products is not covered
under warranty.
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 signicant 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.
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NOTICE: The foot stiness 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 qualied prosthetist. Any adjustment or modications
should be done by the clinician and not by the user.
NOTICE: If any serious incidents occur in relation to the
usage of the device, contact your Fillauer Representative
and the appropriate authority in your country.
Alignment (Specications &
PreparationsBefore Use)
Proximal attachment
Attachment of the foot may be achieved via the proximal pyramid to any
ISO 10328 compliant, Fillauer or equal, standard adult pyramid receiver.
Torque all set screws to the setting specied by the manufacturer of
the pyramid receiver. For Fillauer components, this is 15N·m. Proper
threadlocker must be used for nal delivery per the component
manufacturer’s specications.
Figure 2
7
Static and Bench Alignment
Standard bench alignment techniques may be used for the Element
(Figure 2). Before aligning, the initial heel height should be established.
The Element is designed for a ⅜ inch or 1 cm heel height. The initial
heel height can be established with a simple spacer under the heel.
The top of the pyramid should be parallel with the work surface before
proceeding with alignment. A backward leaning pylon indicates that the
heel height is too low and will make late-stance rollover dicult.
Transtibial Bench Alignment
The socket should be set with the proper amount of inset found in
the evaluation. The plum line from the bisection of the socket at the
proximal brim in the frontal and sagittal plane should bisect the ankle
pyramid. The foot may be slightly inset, 1–12 mm, depending on the
limb length. Short limb lengths are set with very little inset of 2–3
mm and longer limb lengths may tolerate a greater varus thrust of
10–12 mm. The longitudinal axis of the foot will be externally rotated
approximately 5° by aligning the medial border of the foot with the line
of progression.
Transfemoral Bench Alignment
Alignment at the transfemoral level should be consistent with the
instructions provided by the manufacturer of the prosthetic knee in use.
Dynamic Alignment
The Element is exible and conforms well to the ground. This
characteristic may make the foot appear to be properly aligned after
the static alignment. However, small adjustments in the alignment
however will smooth the transition from heel to toe and optimize gait
and eciency. Patient feedback during this process is essential. In
the dynamic alignment of the foot, the socket exion angle, and heel
stiness are altered to achieve optimal alignment and patient gait.
• Check for smoothness of gait and ground contact during stance
phase.
• If the heel is too soft, there may be delayed heel rollover from heel
strike to midstance. Dorsiexing the foot or moving the heel bumper
anteriorly may resolve this issue.
• If the heel is too rm, heel rollover may be too rapid from heel strike
to mid stance. Also, patient may complain of anterior distal pressure.
Plantarexing the foot or moving the heel bumper posteriorly may
resolve this issue.
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• If the anterior keel rollover progresses too quickly from midstance
to toe loading, the patient may say that they are “walking up a hill.”
Plantarex the foot to provide more anterior support.
• If the anterior keel rollover hesitates from midstance to toe loading,
the patient may say that they are “walking down a hill.” Dorsiex the
foot to increase the rate of rollover.
Bumper Replacement
If the heel bumper needs to be moved or replaced, it can be removed
by application of heat and solvent being sure not to allow any solvent
to contact the Poron® pad that is between the pylon and foot
plate. The pylon should then be lightly sanded with 120 grit sandpaper
to provide a good bonding surface. The bumper is then adhered to the
carbon using cyanoacrylate instant adhesive (commonly referred to as
“super glue”). The bumper MUST NOT be placed more anteriorly than
the main foot bolt connecting the DuraShock unit. Contact Fillauer for
the proper bumper for the foot size.
If a smooth stance phase of gait cannot be achieved, contact Fillauer for
additional assistance.
Consumable Components:
Foot Shell and Spectra®Sock
The Element uses a unique cosmetic foot shell that is exible and
durable (sold separately). Use care in the installation and removal of the
foot shell to maintain its appearance and durability. Always use the shell
with an internal Spectra sock (included). Never use a sharp-edged tool
such as a screwdriver to install or remove the foot shell.
Installation
• Slide the provided Spectra sock onto the foot from toe to heel, pulling
excess material to the ankle so that it does not bunch under the heel
or toe of the foot.
• Insert the forefoot into the foot shell as far as possible. Set the heel
on a supportive surface with the toe up and push the shell onto the
foot until the toe is in position.
• Rotate the foot side to side to allow the foot shell to slide onto the
heel.
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• Push the foot shell up onto the heel or, if necessary, insert a shoehorn
into the foot shell and allow the heel to slide down a shoehorn
into the heel lock. The heel must lock (Figure 3) in place for proper
function and safety.
• The foot shell should be inspected daily by the user and replaced by
the clinician when tears or breaks are evident in the surface of the
shell.
• The Spectra sock should be inspected and replaced if needed every
3–6 months by the prosthetist. The plantar surface of the foot
should be inspected at this time and if there is excessive wear of the
protective soling, it should be replaced.
Heel Lock
Figure 3
Removal
• Place the foot on the bench so that the heel is hanging over the edge
of the bench.
• Apply downward force to the top portion of the foot shell at the heel.
The heel plate should pop out of the heel lock, allowing removal of
the foot shell by hand.
• If the foot shell is too tight, a smooth-edged shoehorn may be used to
disengage the heel lock.
Compatibility
Fillauer feet are appropriate for use with Fillauer or equal, ISO 10328
compliant, endoskeletal components. A Fillauer Spectra sock and foot
shell should be used with this device, the t of other manufacturers’
shells cannot be guaranteed.
10
Disposal/ Waste Handling
The product must be disposed of in accordance with applicable local
laws and regulations. If the product has been exposed to bacteria or
other infectious agents, it must be disposed of in accordance with
applicable laws and regulations for the handling of contaminated
material.
All metal components may be removed and recycled at the appropriate
recycling facility.
Warranty
• 36 months from date of patient tting
• Foot Shell (sold separately) — 6 months from date of patient tting.
User Instructions
The providing health care professional must review the following
information directly with the user.
Care and Maintenance
WARNING: If the foot performance changes or it begins to
make noise, the patient should immediately contact his or
her practitioner. These things may be as sign of a failure
of the foot or other part of the prosthesis that could
result in a fall or other serious injury.
CAUTION: Attachment, alignment, and delivery of the foot
must be performed by or under the direct supervision of
a qualied prosthetist. Any adjustment or modications
should be done by the clinician and not by the user.
CAUTION: 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.
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