fillauer Aeris Performance LP Instruction Manual

fillauer Aeris Performance LP

Intended Use

The Aeris Performance LP (APLP) 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 APLP combine to provide a high rate of energy return while the separation between those springs reduces stiffness in all three planes. Patients will experience significantly improved range of motion when walking up and down slopes compared to similar devices as well as greater compliance on uneven terrain.

Indications

• Low to moderate activity transtibial or transfemoral amputees as defined by functional K3 activity levels
• Unilateral or bilateral patients
• Patients that would benefit from moderate energy return
• Patients weighing up to 275 lbs. (125 kg)

Contraindications

• Clearance below 5 in. (13 cm)
• Patients weighing over 275 lbs. (125 kg)

The device is intended for single patient use only.

Performance Characteristics

• Patient weight: Up to 275 lbs. (125 kg)
• Foot weight: 15.87 oz. (450 g) for size 27cm
• Build height: 5 in. (13 cm)
• Functional level: K3
• 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.

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 APLP 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 prolongedextreme temperatures (< -15 °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.
• 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 manufacturer’s specifications.

Static and Bench Alignment
Standard bench alignment techniques may be used for the Aeris Performance LP foot (Figure 2). Before aligning, the initial heel height should be established. The Aeris Performance LP 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 difficult.

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 LP foot is flexible 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 dorsiflexion 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 dorsiflexion 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 plantarflexion of the foot may solve this problem.
• If the foot progresses too quickly from midstance to toe loading, moving the socket posteriorly or increased plantarflexion may resolve this issue.
• If the foot hesitates from midstance to toe loading, moving the socket anteriorly or dorsiflexion 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

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

Consumable Components

Foot Shell and Spectra® Sock
The APLP 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, endoskeletal components. A Fillauer 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 can 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 Aeris Performance LP. 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 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.

www.fillauer.com

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+46 (0)8 505 332 00
© 2021 Fillauer LLC
M059/07-09-12 /10-04-21/Rev.1

References

• Home | Fillauer LLC | Orthotics and Prosthetics Manufacturer
• Home | Fillauer LLC | Orthotics and Prosthetics Manufacturer

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