Fillauer AllPro PM User manual

AllPro PM
Product Manual

2
Contents
Intended Use................................................................3
Warnings and Precautions ....................................................4
Alignment (Specications & PreparationsBefore Use).............................5
Foot Shell and Spectra Sock (ConsumableComponents)...........................8
Compatibility ................................................................9
Disposal/ Waste Handling ....................................................9
Warranty ...................................................................9
User Instructions ...........................................................10
Serious incidents ...........................................................10
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3
Intended Use
The AllPro PM posterior-mounted, prosthetic foot is intended for use in lower
extremity prostheses. The foot uses a long carbon pylon (Figure 1) to maximize
energy storage and release during gait, similar to a “running blade”. It has a special
wave spring footplate 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 strong users and especially those with longer residual limbs and the height
requirements that come with those limbs. The AllPro PM bridges the gap between
everyday foot and sport specic prosthesis in a single device.
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 low build height
• Patients weighing up to 330 lbs. (150 kg)
Contraindications
• Clearance below 4 in. (10 cm)
• Patients weighing over 330 lbs. (150 kg)
The device is intended for single patient use only.
Performance Characteristics
• Patient weight: Up to 330 lbs. (150 kg)
• Foot weight: 21 oz. (600 g)
• Build height: 4 in. (10 cm)
• Functional level: K3 – K4
• Durable: meets ISO-22675 standard
• 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 are stored in a cool, clean, dry environment
away from harsh chemicals (chlorine, acids, acetone, etc.).

4
Warnings and Precautions
CAUTION: The AllPro PM is designed to be maintenance free and should
not be disassembled.
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 signicant 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 6 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 competent authority
in your country.

5
Alignment (Specications &
PreparationsBefore Use)
Proximal attachment
The Adjustable Alignment Bracket (PN 180-10-4000) may be used for temporary,
adjustable attachment during alignment. The Posterior Mounting Bracket (PN 180-
10-2010), typically used for permanent attachment, may also be used in a temporary
setting but only allows angular adjustments. Permanent attachment of the foot may be
achieved via direct lamination or use of the Posterior Mounting Bracket. See Posterior
Mounting Bracket or Adjustable Alignment Bracket instructions for more information
or request assistance from Fillauer for further instruction in this process.
5°
Figure 1
Static Alignment—Sagittal Plane
Before aligning, the initial heel height should be established. The AllPro PM employs a
5° posterior lean (Figure 1) with a 10 mm (⅜ in.) heel block to preload the anterior keel.
When the patient is weight bearing, the socket bisection should settle to a vertical to
slightly exed position.
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 keel of the foot (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.

6
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. Attachment to the
prosthesis will be challenging with transfemoral amputees and the method of doing so
is at the discretion of the treating clinician.
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 bending of the carbon pylon is
desirable for optimal performance and foot deection may be more noticeable
during dynamic alignment. Up to ½ in. (12 mm) additional height may be needed to
accommodate for spring deection. Patient feedback during this process is essential.
Use the Adjustable Alignment Bracket Kit for easier alignment of any Fillauer posterior
mounted foot. If using the Posterior Mounting Bracket alone, adjustment of plantar/
dorsiexion angles using the alignment wedges will help achieve a smooth transition
from heel to toe and provide adjustment of transverse plane foot rotation.
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.

7
Heel Bumper Installation
The foot is supplied with two heel bumpers: the PU Foam bumper (40A) is standard
and pre-installed. If desired, the rmer bumper (Solid Rubber 60A) can be installed to
make the heel rmer (Figure 2).
Figure 2
ApplyGlue
PinLock
HeelLock
Heel
Bumper
1. Pull the pylon and foot plate apart. Insert a piece of plastic to keep the gap 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
If a smooth stance phase of gait cannot be achieved, contact Fillauer for additional
assistance.

8
Foot Shell and Spectra Sock
(ConsumableComponents)
The AllPro PM 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
• Pull the Spectra Sock provided 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 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.
• 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.
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 and 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’s adult posterior mounting feet are appropriate for use with the adult sized,
Fillauer Posterior Mounting Bracket and Adjustable Alignment Bracket. A Fillauer
spectra sock and foot shell (not included) 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

10
User Instructions
The providing health care professional must review the following information directly
with the user.
Care and Maintenance
• 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.
• The foot shell is designed to provide realistic appearance and maximum
performance of the AllPro PM. 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.
• 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.
• 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.
• If the foot performance changes or if it makes noise, the patient should immediately
contact his or her practitioner.
• The foot should be inspected by the clinician every 6 months for signs of abnormal
wear and to assure that the attachment/alignment screws are secure.
• 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.
Serious incidents
In the unlikely event of a serious incident, seek immediate medical help and contact
your prosthetist at the earliest possible convenience.

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Fillauer LLC
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Chattanooga, TN 37406
423.624.0946
3938 S. 300 W.
Salt Lake City, UT 84107
801.281.9964
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Kung Hans väg 2
192 68 Sollentuna, Sweden
[phone]
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M071/11-03-16/06-28-21/Rev.1