fillauer AllPro XTS Bumper Instruction Manual

: June 3, 2024
: fillauer

AllPro XTS Bumper

AllPro XTS

Product Manual

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Intended Use

The AllPro XTS prosthetic foot is intended for use in lower extremity prostheses. The
foot uses a carbon C-spring pylon (available in two heights) to maximize energy storage
and release during gait, similar to a “running blade”. It has a special wave spring foot
plate for shock absorption and terrain compliance at heel strike. This foot is intended
for patients throughout the K3 and K4 spectrum with performance that accommodates
daily living to 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
and provides vertical shock and torsion features. The shock and torsion reducing XTS
module’s elastomer bumper provides adjustability to tune the device to the patient’s
preference. Each of the different stiffness bumpers can be replaced or exchanged
in the field to fine tune the amputee’s experience. The AllPro XTS bridges the gap
between everyday foot and sport specific prosthesis in a single device.

Indications

• Moderate to very high activity transtibial or transfemoral amputees as defined by
functional K3 and K4 activity levels
• Unilateral or bilateral patients
• Patients that would benefit from high energy return
• Patients that would benefit from shock absorption
• Patients weighing up to 275 lbs. (125 kg)

Contraindications

• Patients weighing over 275 lbs. (125 kg)
• Build height below 6.4 inches (15.2 cm)

The device is intended for single patient use only.

Performance Characteristics

Patient weight: Up to 275 lbs. (125 kg)
Foot build height and weight (26 cm, Category C):
6.4-inch model: 1.6 lbs. (728 g)
8.4-inch model: 1.7 lbs. (789 g)
Functional level: K3 – K4
Primary Materials: Carbon Composite, Aluminum, Polyurethane, and Stainless Steel
Durable: meets ISO-22675 standard
Waterproof: The foot unit is waterproof to 1 meter. See additional information
below.

Parts and Accessories

Description Part Number
Sealing Boot 229-40-0008
Lower Perch with Pins and Lower Bearing 229-10-0003
Upper O-ring with Silicone Super Lube 229-10-0005
Lower O-ring with Silicon Super Lube 229-10-0006
Closure Nut 229-30-0007

Pre-installed Bumpers

23-A3

|

24-A3

|

25-B4

|

26-B4

|

27-C6

|

28-C6

|

---|---|---|---|---|---|---

23-B4

|

24-B4

|

25-B4

|

26-B4

|

27-C6

|

28-C6

|

29-D7

23-B4

|

24-B4

|

25-C5

|

26-C5

|

27-C6

|

28-C6

|

29-D7

23-C5

|

24-C5

|

25-C5

|

26-C5

|

27-D7

|

28-D7

|

29-D7

23-C5

|

24-C5

|

25-D6

|

26-D6

|

27-D7

|

28-D7

|

29-E8

|

25-D6

|

26-D6

|

27-E8

|

28-E8

|

29-E8

Storage and Handling

It is recommended that prosthetic feet are stored between –5° and 50°C in a clean, dry
environment away from harsh chemicals (chlorine, acids, acetone, etc.).

Warnings and Precautions

CAUTION: Fillauer has tested (ISO 10328) and recommends the use
of standard, adult, endoskeleton components from Fillauer with all
Fillauer feet. Components from other manufacturers may or may not be
compatible. Failure due to use of other manufacturer’s 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 significant deterioration if not allowed to fully dry
before return to normal use and are not covered under warranty for this
failure.

CAUTION: The closure nut must be torqued to 44 ft.-lbs. (60 N·m) prior to
use if removed for any reason during the fitting. Under no circumstances
apply any Loctite.

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.
Any adjustment or modifications 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 (Specifications & 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 specified by the manufacturer of the pyramid receiver. For Fillauer
components, this is 15 N·m. Proper thread locker must be used for final delivery per
the component manufacturers specifications.

Static Alignment—Sagittal Plane
Before aligning, the initial heel height should be established. Using the adapter surface
for reference, the All Pro employs a 2° posterior lean (Figure 2) 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.

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 sufficiently
to provide dynamic response late in stance. Some compression of the C-spring is
desirable for optimal performance and foot deflection may be more noticeable during
dynamic alignment. Patient feedback during this process is essential. Adjustments of
the plantar/dorsiflexion angles will help the patient achieve a smooth transition from
heel to toe.

Check for smoothness of gait and ground contact throughout the stance phase
of gait.
If the heel rollover is delayed from heel strike to midstance, or the heel
compression is too great, dorsiflexion of foot may correct this problem. It is also
possible to replace the heel bumper with the firmer, 60A bumper supplied with
the foot. See bumper installation instructions.
If the heel rollover is too rapid from heel strike to midstance, or the heel is too
hard, plantarflexion of the foot may solve this problem. Ensure that the softer
bumper is installed before making any angular adjustments.
If the rollover is too rapid from midstance to toe loading, increased
plantarflexion may be required.
If the rollover from midstance to toe loading is delayed, dorsiflexion may be
indicated.
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.
Torsional resistance, range of motion and vertical shock can be adjusted at this
time or later to meet the individual user’s preferences for performance (softer
or firmer).

If a smooth stance phase of gait cannot be achieved, contact Fillauer for additional
assistance

Heel Bumper Installation
The foot is supplied with two heel bumpers: 40A durometer is standard and preinstalled.
If desired, the “Firm” bumper (60A) can be installed to stiffen the heel
performance.

Pull the pylon and foot plate apart. Insert a piece of plastic to hold parts open.
Remove the Heel Bumper by pulling it up and away from the heel lock.
Install the new bumper and ensure the Lock Pins engage the Heel Bumper
properly.
When the desired bumper density is determined, remove the bumper, and apply
Superglue to the Heel lock and reinstall the bumper.

Changing the Toe Stiffness
The toe stiffness is pre-determined by the load category of the anterior spring
members. This stiffness can be dynamically adjusted by changing the amount of
plantar/dorsi-flexion of the foot. This adjustment increases or decreases the amount of
anterior support during gait.
If a smooth stance phase of gait cannot be achieved, contact Fillauer for additional
assistance.

Bumper Replacement Procedure

NOTICE: The bumper replacement procedure requires the closure
nut to be torqued to 44 ft-lbs. (60 N·m). Be sure that a torque wrench
capable of 44 ft-lbs. (60 N·m) is available before beginning the bumper
replacement procedure.

1. Bumper Engagement: Note the holes in the bumper match and slide over the
pins in the end cap. The bumper should be fully seated in the bottom of the
end cap.

2. Fix the AllPro XTS in a vice as shown being sure to use soft jaws, a leather shim
or other material to protect the foot from the jaws of the vice.

3. Insert the spanner wrench making sure the 6 pins seat fully in the closure nut.
Use a ⅜ in. drive ratchet wrench to loosen the closure nut. Make sure not to
rotate the pyramid during assembly or disassembly.

4. Once the closure nut is removed, slide off the distal cap to have access to the
elastomer bumper. Remove the elastomer bumper then replace as desired for
performance.

5. Replace with the desired elastomer bumper, note that it must slide over all
three pins and be fully seated in the end cap. Then, slide the end cap/bumper
assembly back in the housing.
6. It is very important that the teeth or spline features on the distal cap mate and
slide into the groove for them on the housing. There are 3 clearly identifiable
spline features that are taller than the rest on the end cap and will be aligned
with the housing before the rest engage. For reference, one of the 3 splines
also has a small notch that will align with a notch on the housing. This
engagement feature ensures that when assembled, it can only be done in the
correct alignment.
7. Tighten the closure nut around the housing by hand as tight as possible. Use a
torque wrench at a 90-degree orientation to the spanner wrench and torque to
the mandatory 44 ft.-lb. (60 N·m). Under no circumstance should you use Loctite
on these threads.

Foot Shell and Spectra Sock

(Consumable Components)

The AllPro XTS uses a unique cosmetic foot shell that is flexible 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.
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.

Compatibility

Fillauer feet are appropriate for use with Fillauer or equal, ISO 10328 compliant,
Endo skeletal components. A Fillauer spectra sock and foot shell should be used with
this device, the fit 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

36 months from date of patient fitting
Foot Shell (sold separately): 6 months from date of patient fitting

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 qualified prosthetist.
Any adjustment or modifications 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 fiber and soling materials. If debris is present, the
foot and shell should be rinsed and allowed too 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 a serious incident occurs in relation to the use of the device, users
should seek immediate medical help and contact their prosthetist, local competent
authority and Fillauer at the earliest possible convenience. Clinicians should at
any time contact their local Fillauer representative and local competent authority
immediately in the event of any device failure.

Fillauer LLC
2710 Amnicola Highway
Chattanooga, TN 37406
423.624.0946

Fillauer Europe
Kung Hans väg 2
192 68 Sollentuna, Sweden
+46 (0)8 505 332 00

EC REP
© 2022 Fillauer LLC
M094/03-21-22/Rev.1

www.fillauer.com