Fillauer AerisPerformance 2 User manual

Aeris
Performance
Product Manual

3
Contents
Intended Use................................................................4
Warnings and Precautions ....................................................5
Alignment (Specications & PreparationsBefore Use).............................6
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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4
Intended Use
The Aeris Performance 2 (AP2) prosthetic foot is intended for use in lower extremity
prostheses. The foot uses three carbon composite elements (Figure 1) that conform to
terrain while storing and releasing energy during gait. The two upper carbon springs in
the AP2 combine to provide a high rate of energy return while the separation between
those springs reduces stiness in all three planes. Patients will experience signicantly
improved range of motion when walking up and down slopes compared to similar
devices as well as greater compliance on uneven terrain.
Lower Foot
Plate
Split Toe
Design
Pylon Main
Spring Pylon Top Spring
Figure 1
Indications
• Moderate to active transtibial or transfemoral amputees as dened by functional K3
and K4 levels
• Unilateral or bilateral patients
• Patients that would benet from greater energy return and multi-axial function
• Patients weighing up to 330 lbs. (150 kg)
Contraindications
• Build height below 6.75 in. (17 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: 18.35 oz. (520 g)
• Build height: 6.75 in. (17 cm)
• Functional level: K3–K4
• Durability: 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.

5
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 AP2 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 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 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.

6
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.
5°
Figure 2
Static and Bench Alignment
Standard bench alignment techniques may be used for the Aeris Performance 2 foot
(Figure 2). Before aligning, the initial heel height should be established. The Aeris
Performance 2 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
dicult.

7
Transtibial Bench Alignment
The socket should be set with the proper amount of inset found in the evaluation.
A 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 outset 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 Aeris Performance 2 foot is exible and conforms to uneven terrain. This
characteristic may mask forefoot loading anomalies during static alignment that may
then become more noticeable during dynamic alignment. Small alignment changes will
smooth the transition from heel to toe and optimize gait. Patient feedback during this
process is essential. Adjustments of the plantar and dorsiexion angles will help the
patient achieve a smooth transition from heel to toe. The pylon should remain vertical
in the frontal plane throughout gait.
Procedure
• Check for smoothness of gait and ground contact throughout the stance phase of
gait.
• If the tibial progression is slowed from heel strike to midstance, or the heel
compression is too great, moving the socket anteriorly or dorsiexion of foot may
correct this problem.
• If the socket progresses rapidly forward from heel strike to midstance or the heel
seems too hard, moving the socket posteriorly or plantarexion of the foot may
solve this problem.
• If the foot progresses too quickly from midstance to toe loading, moving the socket
posteriorly or increased plantarexion may resolve this issue.
• If the foot hesitates from midstance to toe loading, moving the socket anteriorly or
dorsiexion may be indicated.
• Check to make sure the pylon is vertical throughout gait. If there is a medial lean,
tighten the proximal medial screw; if there is a lateral lean, tighten the proximal
lateral screw.
If a smooth stance phase of gait cannot be achieved, contact Fillauer for additional
assistance.

8
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”). Contact Fillauer for the proper bumper for the foot size.
Consumable Components:
Foot Shell and Spectra®Sock
The AP2 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.
• 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.
Figure 4
Heel Lock

9
• 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. 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 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 can 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

10
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 Aeris Performance 2. 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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423.624.0946
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[phone]
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M058/06-29-12/10-04-21/Rev.1