Fillauer AllPro DM User manual

AllPro DM
Product Manual

2
Contents
Intended Use................................................................3
Warnings and Precautions ....................................................4
Alignment (Specications & PreparationsBefore Use).............................5
Consumable Components: Foot Shell and Spectra®Sock ..........................8
Compatibility ................................................................9
Disposal/ Waste Handling ....................................................9
Warranty ...................................................................9
User Instructions ...........................................................10
Serious Incidents ...........................................................11
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Intended Use
The AllPro prosthetic foot is intended for use in lower extremity prostheses. The foot
uses a carbon C-spring pylon (available in four heights) to maximize energy storage
and release during gait, similar to a “running blade” (Figure 1). It has a special wave
spring foot plate for shock absorption and terrain compliance at heel strike. This foot
is intended for patients that require competition level energy return with the ability
to stop and turn that only comes with a heel. It is also an exceptional walking foot for
moderate to strong users. The AllPro DM bridges the gap between everyday foot and
sport specic prosthesis in a single device.
12 in.
10 in.
8 in.
6 in.
Figure 1
Indications
• Moderate to very high activity transtibial or transfemoral amputees as dened by
functional K3 and K4 activity levels
• Unilateral or bilateral patients
• Patients that would benet from high energy return
• Patients that would benet from shock absorption
• Patients weighing up to 330 lbs. (150 kg)
Contraindications
• Patients weighing over 330 lbs. (150 kg)
The device is intended for single user/patient use only.
Performance Characteristics
• Patient weight: Up to 330 lbs. (150 kg)
• Foot weight: 15.9 oz. (450 g)
• Build height: 6, 8, 10, or 12in. (15.2, 20.3, 25.4, or 30.5cm)
• Functional level: K3–K4
• Durable: meets ISO-22675 standard

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• Primary Materials: Carbon composite and stainless steel.
• Waterproof: The foot unit is waterproof to 1 meter. See additional information
below
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 AllPro 6inch 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: The AllPro 8, 10, and 12inch is designed with a Reversible
Pyramid Insert that arrives unbonded to allow the prosthetist to adjust
the dynamics of the foot. This insert MUST be bonded following the
instructions below BEFORE nal delivery to allow for safe use of the device.
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 signicant deterioration if not allowed to fully dry
before return to normal use and are not covered under warranty for this
failure.

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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 stiness 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 qualied prosthetist.
Any adjustment or modications 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 (Specications &
PreparationsBefore 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 specied by the manufacturer of the
pyramid receiver. For Fillauer components,
this is 15N·m. Proper thread locker must be
used for nal delivery per the component
manufacturer’s specications.
Reversible Pyramid Insert (RPI)
AllPro 8, 10, and 12 inch pylons are equipped
with a reversible pyramid insert (RPI). The
6inch pylon is permanently mounted in the
centered 32.5% weight-line position.
Pyramid
Dome
Pyramid
Insert
Bolt
Bushing
30% Position
(Increased
Dynamics)
Pyramid
Dome
Pyramid
Insert
Bolt
Bushing
35% Position
(Standard)

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The RPI is set at 35% of foot length. If the user would benet from more dynamic
response, the RPI adapter can be ipped 180°. See instructions below for nal
assembly.
1. Walk patient in both positions to determine the desired pyramid position.
2. Before nal delivery of the prosthesis, use the epoxy adhesive provided or
equivalent to secure the pyramid assembly. Fabtech systems +PLUSeries®
Composite 1 Minute Adhesive or equivalent is acceptable.
3. Apply adhesive to the exterior faces of the RPI adapter and push into desired
position.
4. Apply adhesive to the bushing shaft and insert into hole of RPI adapter.
5. Apply adhesive to the top surface of RPI insert and bushing shaft. Then install
pyramid dome and ensure pin location lines up with the insert pin hole.
6. Apply adhesive to the top of the bolt threads and insert bolt through bushing.
7. Use 6 mm hex wrench to torque bolt to 30 N·m.
8. Wipe away any excess adhesive with towel wetted with alcohol.
Heel Bumper Installation
The foot is supplied with two heel bumpers: 40A durometer is standard and pre-
installed. If desired, the “Firm” bumper (60A) can be installed to stien the heel
performance.
Apply Glue
Pin Lock
Heel Lock
Heel
Bumper
1. Pull the pylon and foot plate apart. Insert a piece of plastic to hold parts open.
2. Remove the Heel Bumper by pulling it up and away from the heel lock.
3. Install the new bumper and ensure the Lock Pins engage the Heel Bumper
properly.
4. When the desired bumper density is determined, remove the bumper and apply
Superglue to the Heel lock and reinstall the bumper.
Static Alignment—Sagittal Plane
Before aligning, the initial heel height should be established. Using the adapter surface
for reference, the AllPro employs a 2° posterior lean (Figure 1) with a ⅜ inch (10 mm)
heel block to preload the anterior keel. When the patient is weight bearing, the adapter
surface should settle to a neutral or level position.

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Transtibial Frontal Plane Alignment
A plum line from the bisection of the socket at
the proximal brim in the frontal and sagittal plane
should bisect the ankle pyramid (Figure 2). The
foot may be slightly inset, 1–12 mm, depending
on the limb length. Most runners prefer a wider
base of support with the foot slightly lateral to the
distal bisection 7–13 mm. The longitudinal axis of
the foot will be externally rotated approximately
5–8° by aligning the medial border of the foot with
the line of progression.
Transfemoral Static 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
It is important to align the prosthesis so that the anterior keel is loaded suciently
to provide dynamic response late in stance. Some compression of the C-spring is
desirable for optimal performance and foot deection may be more noticeable during
dynamic alignment. Patient feedback during this process is essential. Adjustments of
the plantar/dorsiexion angles will help the patient achieve a smooth transition from
heel to toe.
1. Check for smoothness of gait and ground contact throughout the stance phase
of gait.
2. If the heel rollover is delayed from heel strike to midstance, or the heel
compression is too great, dorsiexion of foot may correct this problem. It is also
possible to replace the heel bumper with the rmer, 60A bumper supplied with
the foot. See bumper installation instructions.
3. If the heel rollover is too rapid from heel strike to midstance, or the heel is too
hard, plantarexion of the foot may solve this problem. Ensure that the softer
bumper is installed before making any angular adjustments.
4. If the rollover is too rapid from midstance to toe loading, increased
plantarexion may be required.
5. If the rollover from midstance to toe loading is delayed, dorsiexion may be
indicated.
6. Check to make sure pylon is vertical in the frontal plane at midstance. This
angulation will be done by moving the bracket, so extra time spent in bench
alignment to properly match the patient’s current angulation is advised.
If a smooth stance phase of gait cannot be achieved, contact Fillauer for additional
assistance.
Figure 2
2°

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Consumable Components:
Foot Shell and Spectra®Sock
The AllPro 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.
Figure 3
Heel Lock
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.
• 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.
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.

9
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.
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
• 24 months from date of patient tting
• Foot Shell (sold separately) - 6 months from date of patient tting

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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 qualied prosthetist.
Any adjustment or modications 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.
CAUTION: The foot 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.
CAUTION: The foot shell is designed to provide realistic appearance and
maximum performance of the AllPro. The life of the foot shell will depend
on level of activity and degree to which it is protected from wear and
damage with socks and shoes. Socks and shoes should be worn at all
times and should be allowed to dry fully after exposure to water to prevent
damage to the shell.
CAUTION: Patients should inspect the shell daily for signs of cracks or
holes and for the presence of sand or other debris. If the foot shell shows
signs of failure, it should be replaced as soon as possible to prevent
damage to the carbon ber and soling materials. If debris is present, the
foot and shell should be rinsed and allowed to fully dry.
CAUTION: The foot shell may also be cleaned with a soft cloth and a soap
and water solution or with rubbing alcohol (70%). Do not use acetone. It
will damage the foot shell.

Serious Incidents
In the unlikely event of a failure resulting in a fall and/or injury, seek immediate
medical help and contact your prosthetist at the earliest possible convenience.

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Fillauer LLC
2710 Amnicola Highway
Chattanooga, TN 37406
423.624.0946
3938 S. 300 W.
Salt Lake City, UT 84107
801.281.9964
Fillauer Europe
Kung Hans väg 2
192 68 Sollentuna, Sweden
[phone]
EC REP
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M065/01-21-15/10-04-21/Rev.1