PROYEOR F15 Agilix Class-III Foot Instruction Manual

PROYEOR F15 Agilix Class-III Foot

Product Information

The Agilix F15 is a prosthetic foot designed for use by individuals with lower limb amputations. It is available with a regular toe or right/left sandal toe option and comes with a set of elastomer stiffening bumpers. The foot is suitable for individuals with a foot size ranging from 22 to 31 cm. The Agilix F15 features a build height ranging from 140 mm to 173 mm and a heel height of 10 mm. The weight of the foot varies depending on the size, with the smallest size weighing 496 g and the largest size weighing 755 g. The foot is designed to provide energy storage and return during the gait cycle. This device has been tested according to ISO 10328 standards and can support a maximum patient weight of up to 166 kg for 2 million cycles. The selection of the appropriate foot category is based on the patient’s weight and activity level.

Product Usage Instructions

1. Before using the Agilix F15, read the instructions carefully.
2. Transmit points 12, 13, 14, 15, 16, 17, and 18 of the user manual to the patient.
3. Included items:
   • Agilix Foot with regular toe
   • Agilix Foot with sandal toe, right
   • Agilix Foot with sandal toe, left
   • Suitable sock
   • Stiffening bumpers
   • Foot Shell Removal Tool (sold separately)
   • Foot shell with regular toe (sold separately)
   • Foot shell with sandal toe (sold separately)
4. Ensure that the foot is aligned correctly and adjust the alignment if necessary. The alignment can be static or dynamic.
5. Install the foot on the prosthetic socket according to the mounting instructions provided.
6. Make the necessary adjustments to ensure a proper fit and alignment for the individual user.
7. Check for any malfunctioning of the foot, such as a too soft or too stiff heel or foot. Refer to point 11 of the user manual for troubleshooting.
8. Follow the recommended maintenance and cleaning procedures to keep the foot in good condition.
9. Consider the environmental conditions in which the foot will be used and ensure that it is suitable for those conditions.
10. Dispose of the foot appropriately when it is no longer usable.

INCLUDED ITEMS

catalogue)
Foot shell with sandal toe (no cap)| FTC-2M-1

DESCRIPTION

Agilix™ is an energy-return prosthetic foot consisting of:

• A carbon keel
• A carbon sole plate
• A male pyramid connection
• A Spectra® sock

Available with regular toe or right or left sandal toe and delivered with a set of elastomer stiffening bumpers.

PROPERTIES

*Based on sizes 23, 26, 29, cat. 4, with foot shell, Spectra sock and 10 mm heel height

This device has been tested according to ISO 10328 for a maximum patient weight up to 166 kg for 2 million cycles.

Selection of foot category based on patient’s weight and activity level

*Weight _)_| lbs| 100-115| 116-130| 131-150| 151-170| 171-195| 196-220| 221-255| 256-285| 286-325| 326-365
kg| 44-52| 53-59| 60-68| 69-77| 78-88| 89-100| 101-116| 117-130| 131-147| 148-166
Activity level| Low| 1| 1| 2| 3| 4| 5| 6| 7| 8| 9
Moderate**| 1| 2| 3| 4| 5| 6| 7| 8| 9| –

*) Body mass limit not to be exceeded (ISO 10328)

MECHANISM OF ACTION
During the strike phase, the sole and heel store energy, which they return in the middle of the stance phase. This property creates the impetus enabling the forefoot to accumulate energy and return it upon the step completion.

INTENDED USE/INDICATIONS

This medical device is supplied to healthcare professionals (prosthetists), who will train the patient in its use. The prescription is drawn up by a doctor who assess the patient’s ability to use the device.
This device is for multiple use on a SINGLE PATIENT. It must not be used on another patient.

This device is intended to be integrated in a custom-made external lower limb prosthesis to ensure the function of the foot in patients with unilateral or bilateral lower limb amputation and/or congenital limb deficiencies.
This device is indicated for patients with moderate activity level (K3) for walking and physical activities without excessive overload. Maximum weight (load carrying included): 166 kg / 365 lbs (See table §3)

CLINICAL BENEFITS

• Walking comfort
• Reduction of joint impacts
• Stability on variable terrain
• Possible walking on uneven ground

ACCESSORIES AND COMPATIBILITY
An appropriate foot shell must be mounted on the foot module (refer to our catalogue). The foot includes a male pyramid connection designed to be compatible with standard female pyramid connectors (see our catalogue).

ALIGNMENTS

Bench Alignment

Before installing the prosthesis on the patient:

• Align the foot module in plantar/dorsal flexion, by inserting the foot (with foot shell) into the shoe to account for the heel height
• Align the socket in adduction/abduction, to ensure an appropriate angle in the frontal plane
• Align the socket in flexion/extension, to ensure an appropriate angle in the sagittal plane
• Adjust the position of the socket so that the load line falls to the anterior dome of the pyramid (see illustration)

Dynamic Alignment
To optimize roll-over from heel to forefoot, adjust the following variables:

• Foot position in the anterior/posterior plane
• Plantar/dorsal flexion
• Heel flexibility

The dynamic alignment is performed in accordance with good professional practices.

ASSEMBLY

The Agilix is pre-assembled and consists of a foot module, a Spectra sock and a foot shell. After dynamic alignment, tighten the pyramid adjustment screws according to the specifications of the connector manufacturer. Secure pyramid adjustment screws with a thread locking adhesive (i.e., Loctite 242).

Spectra® sock
A Spectra sock is included to protect the foot shell and minimize noise. It must be placed on the foot module before mounting the foot shell.

Foot shell
To install and remove the foot shell, use the foot shell removal tool to prevent damage of the foot module. Never remove the foot from the foot shell by pulling manually. This could damage the foot.

ADJUSTMENTS

The heel stiffness at foot loading can be adjusted using the stiffening bumpers. The bumpers may be temporarily attached using the pre-applied adhesive in the location indicated in the table below. The recommended location will stiffen the heel of about 1 category. If necessary, move the bumpers anteriorly (stiffer) or posteriorly (softer) to get the desired stiffness. For permanent placement, clean off the pre-applied adhesive with acetone and adhere bumpers using cyanoacrylate glue.

Foot size (A)| Distance from the rear end of the sole (B)|
---|---|---
22-25 cm| 25 mm / 1’’
26-28 cm| 38 mm / 1,5’’
29-31 cm| 48 mm / 1,9’’

TROUBLESHOOTING

·    Toe feels excessively stiff

·    Knee hyperextension

| ·    Shift socket anteriorly in relation to the foot

·    Attach stiffening bumpers. See section 10 above for installation details

Heel too hard| ·    Rapid knee flexion, instability

·    Heel to toe progression too fast

·    Lack of energy return sensation

| ·    Shift socket posteriorly in relation to the foot

·    Verify appropriate foot module category

Foot module too stiff| ·    Flat spot in rollover motion at slow cadences| ·    Consider a lower category foot module
Foot module too soft| ·    Clicking noise at initial contact

·    Excessive toe deflection with high impact activity

| ·    Consider a higher category foot module

WARNINGS

• In case of damaged packaging, check the integrity of the device.
• Never use the foot without a foot shell.
• Never loosen the pyramid fastening screws.
• The patient must inform their prosthetist if they gain or loses significant weight.
• Always use the foot with a sock and shoe. Failure to adhere to this advice may cause product failure, as well as serious injury.
• Make sure that the foot and inside of the foot shell are free of impurities (e.g., sand). The presence of impurities causes the graphite parts to wear out. Clean the foot according to the instructions (see §16).
• After swimming, using in water or if splashed by a liquid, the foot must be cleaned (see §16).
• If the patient notices any abnormal behavior or feel any changes in the characteristics of the device (noise, play, excessive wear…), or if the device has received a severe impact, they should stop using the device and consult their prosthetist.
• Failure to follow the instructions for use is dangerous and will void the warranty.

CONTRAINDICATIONS

• Use for a patient whose maximum weight (load carrying included) may exceed 166 kg / 365 lbs
• Use for activities associated with a risk of significant impact or excessive overloading

SIDE EFFECTS
There are no known side effects directly associated with the device. Any serious incident that has occurred in relation to the device should be reported to the manufacturer and to the competent authority of the Member State in which the user is established.

MAINTENANCE AND CONTROL

The foot module must be inspected by the prosthetist at least every six months. Inspections at shorter intervals are required if the user is more active. The Spectra sock and the foot shell must be replaced by the prosthetist at regular intervals, depending on the patient’s level of activity. If these parts are damaged, it can lead to premature foot wear. The lifetime of the foot depends upon the patient’s level of activity.

CLEANING
Remove the foot shell and the Spectra sock, clean the foot with clear water and neutral soap and dry carefully. The foot shell can be cleaned with a damp cloth or sponge.

ENVIRONMENTAL CONDITIONS

Temperature range for use and storage: -29 to +49 °C [-20 to 120 °F] Relative air humidity: no restrictions Water-resistant: the device is resistant to occasional immersion and splashes.

DISPOSAL
The foot is made of carbon fiber composite, epoxy, PU polymers, titanium, and stainless steel. The device and its packaging must be disposed of in accordance with local or national environmental regulations.

DESCRIPTION OF THE SYMBOLS

REGULATORY INFORMATION
This product is a CE-marked medical device and is certified as conforming with Regulation (EU) 2017/745.

PROTEOR USA
3 Morgan
Irvine, CA 92618 – USA
+1.855.450.7300
support@proteorusa.com – www.proteorusa.com

PROTEOR SAS
6 rue de la Redoute
21850 Saint-Apollinaire – France
+33 3 80 78 42 42
cs@proteor.com – www.proteor.com

References

• Home - Proteor
• Spark Inspiration - Proteor USA

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