PROTEOR Sierra FS1 Prosthetic Feet Instruction Manual

Sierra FS1 Prosthetic Feet

Product Information

Product Usage Instructions

1. Read the user manual/instructions carefully before using the product.
2. Transmit points 12, 13, 14, 15, 16, 17, and 18 of the user manual to the patient.
3. Check the included items:
   • – Sierra Foot with regular toe (FS1-00-0xAyy-RU*)
   • – Sierra Foot with sandal toe, right (FS1-00-0xAyy-SR*)
   • – Sierra Foot with sandal toe, left (FS1-00-0xAyy-SL*)
   • – Stiffening bumpers (KIT-00-1135U-00)
   • – Foot Shell Removal Tool (ACC-00-10300-00)
   • – Foot shell with regular toe (no cap) (FTC-3M-1)
   • – Foot shell with sandal toe (no cap) (FTC-2M-1)
4. Select the appropriate part based on the user’s requirements:
   • Sierra Foot with regular toe for standard use (FS1-00-0xAyy-RU*)
   • Sierra Foot with sandal toe, right or left, based on user preference (FS1-00-0xAyy-SR / FS1-00-0xAyy-SL)
5. Attach the selected part to the user’s prosthetic leg.
6. If necessary, use the stiffening bumpers to adjust the rigidity of the foot.
7. Ensure proper alignment of the foot:
   • – Static alignment
   • – Line of load
   • – Dynamic alignment
8. Adjust the foot size based on the user’s foot measurements:
   • – 22 to 25 cm foot size with 29 mm amplitude
   • – 26 to 28 cm foot size with 35 mm amplitude
   • – 29 to 31 cm foot size with 48 mm amplitude
9. Check for any malfunctions:
   • – Too soft heel
   • – Too stiff heel
   • – Too stiff foot
   • – Too soft foot
10. Follow the provided warnings and contraindications for safe usage.
11. Refer to the user manual for information on possible side effects, maintenance and inspection, cleaning, environmental conditions, and disposal.
12. Refer to the user manual for a description of symbols used.
13. The product is manufactured by [Manufacturer Name].
14. The product is intended for single-patient, multiple-use.
15. Refer to the user manual for regulatory information.

INCLUDED ITEMS

Included

Sierra Foot with sandal toe, right| FS1-00-0xAyy-SR
Sierra Foot with sandal toe, left| FS1-00-0xAyy-SL
Black Spectra® sock| S0-NPS-200zz-00*| Suitable sock included
Stiffening bumpers| KIT-00-1135U-00| Included
Foot Shell Removal Tool| ACC-00-10300-00| Sold separately
Foot shell with regular toe (no cap)| FTC-3M-1| Sold separately (see catalogue)
Foot shell with sandal toe (no cap)| FTC-2M-1

DESCRIPTION

• Sierra® 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| –
High**| 2| 3| 4| 5| 6| 7| 8| 9| –| –

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 activity 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 Sierra 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

|

29 mm / 1,14’’

26-28 cm

|

35 mm / 1,4’’

29-31 cm

|

48 mm / 1,9’’

TROUBLESHOOTING

Heel too soft

| ·    Foot flat occurs too rapidly

·    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 lose 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 : -20 to 60°C
• 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.

ABOUT COMPANY

• 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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