fillauer K2 Foot Instruction Manual

: June 3, 2024
: fillauer

Table of Contents

Intended Use
Warnings and Precautions
Alignment (Specifications & Preparations Before Use)
Consumable Components: Foot Shell
Compatibility
Disposal / Waste Handling
Warranty
User Instructions
Serious Incidents

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Intended Use

The K2 prosthetic foot is intended for use in lower extremity prostheses. The K2 is engineered from the ground up for the functional level 2 patient. While other K2 designs typically fall into two categories, stiffer SACH feet and softer K3 designs, the Fillauer K2 Foot is a new design specifically for the functional level 2 patient. Patient testing shows K2 level patients walk with a more controlled gait pattern and need more stability at midstance. With this in mind, we engineered the K2 Foot with a unique flexible keel to provide better control and stability. When the patient is ready to go, so is the K2 Foot with a compliant forefoot that loads easily and provides support through toe off.

Indications

Low activity transtibial or transfemoral amputees as defined by functional K2 activity level
Unilateral or bilateral patients
Patients that would benefit from ease of gait initiation
Patients that would benefit from compliance on uneven terrain
Patients weighing up to 365 lbs. (150 kg)

Contraindications

Clearance below 3.5 in. (9 cm)
Patients weighing over 365 lbs. (150 kg)

The device is intended for single patient use only.

Performance Characteristics

Patient weight: Up to 365 lbs. (150 kg)
Foot weight (26cm): 14 oz. (395g)
Build height: 3.5 in. (9 cm)
Functional level: K2
Durable; meets ISO-22675 standard
Primary Materials: Delrin, 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 K2 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 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 patient weight. 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 (Bench) Alignment

Standard bench alignment techniques are used for initial alignment of the K2 Foot. The foot is designed with a 1 cm heel height. Place foot in shoe or use a 1 cm heel wedge to accommodate heel height. Align the center of the pyramid of the foot 10 mm anterior to the sagittal bisection of the proximal brim (Figure 2). Set the desired 5–7° flexion angle in the sagittal plane. In the coronal plane set the desired 3–5° adduction angle to accommodate for knee genu varum. The foot should also be set with 0–12 mm inset relative to the bisection of the proximal brim. Less inset is required for a shorter limb length. Rotate the foot with approximately 5° of external rotation relative to the line of progression.

Dynamic Alignment

The K2 Foot is flexible and conforms well to the ground. This characteristic may make the foot appear to be properly aligned after the static alignment. However, small adjustments in the alignment however will smooth the transition from heel to toe and optimize gait and efficiency. Patient feedback during this process is essential. In the dynamic alignment of the foot, the socket flexion angle and heel
stiffness are altered to achieve optimal alignment and patient gait.

Check for smoothness of gait and ground contact during stance phase.
If the heel is too soft, there may be delayed heel rollover from heel strike to midstance. Dorsiflexing the foot may resolve this issue.
If the heel is too firm, heel rollover may be too rapid from heel strike to midstance. Also, the patient may complain of anterior distal pressure. Plantar flexing the foot may resolve this issue.
If the anterior keel rollover progresses too quickly from midstance to toe loading, the patient may say that they are “walking down a hill.” Plantar flex the foot to provide more anterior support.
If the anterior keel rollover hesitates from midstance to toe loading, the patient may say they are “walking up a hill.” Dorsiflex the foot to increase the rate of rollover.

Changing the toe stiffness

The toe stiffness is predetermined by the foot category selected at the time of order. This stiffness can be dynamically adjusted by changing the A/P position of the foot under the socket and by changing the plantar/dorsiflexion 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.

Consumable Components: Foot Shell

The K2 uses a unique cosmetic foot shell that is flexible and durable. Use care in the installation and removal of the foot shell to maintain its appearance and durability. Never use a sharp-edged tool such as a screwdriver to install or remove the foot shell.

Installation

Apply talcum powder or similar to reduce friction during installation.
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 plantar surface of the foot should be inspected every 3-6 months by the prosthetist 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, endoskeleton 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 may be removed and recycled at the appropriate
recycling facility.

Warranty

24 months from date of patient fitting
Foot Shell — 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 K2. 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.

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2710 Amnicola Highway
Chattanooga, TN 37406
423.624.0946

3938 S. 300 W.
Salt Lake City, UT 84107
801.281.9964

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