PROTEOR FS2 Pacifica LP Class 4 Amputated Foot Prosthesis Instructions

: June 13, 2024
: PROTEOR

Table of Contents

PROTECTOR FS2 Pacifica LP Class 4 Amputated Foot Prosthesis
Product Information
Product Usage Instructions
INCLUDED ITEMS
DESCRIPTION
PROPERTIES
MECHANISM OF ACTION
INTENDED USE/INDICATIONS
CLINICAL BENEFITS
ALIGNMENTS
ASSEMBLY
ADJUSTMENTS
TROUBLESHOOTING
DESCRIPTION OF THE SYMBOLS
Documents / Resources

PROTECTOR FS2 Pacifica LP Class 4 Amputated Foot Prosthesis

Product Information

The product is a prosthetic foot called Pacifica and Pacifica LP. It is available in different variations, including regular toe and sandal toe options for both the right and left sides. The package includes the Pacifica foot, Pacifica LP foot, stiffening bumpers, foot shell removal tool, and foot shells with regular toe or sandal toe. The product is designed for use by prosthetists.

Properties

Foot Side: Right or Left Size:
- Regular Toe: 24 to 25 cm, 26 to 28 cm, 29 to 31 cm
- Sandal Toe: 22 to 25 cm, 26 to 28 cm, 29 to 31 cm
Sandal Toe Option: Yes (for regular toe variations)
Weight:
- Regular Toe: 454 g / 1.0 lbs, 545 g / 1.2 lbs, 705 g / 1.6 lbs
- Sandal Toe: 395 g / 0.9 lbs, 537 g / 1.2 lbs, 746 g / 1.6 lbs
Build Height:
- Regular Toe: 65mm, 66mm, 70mm
- Sandal Toe: 48mm, 54mm, 58mm
Heel Height: 10 mm
Weight Range (kg): 44-52, 53-59, 60-68, 69-77, 78-88, 89-100, 101-116, 117-130, 131-147, 148-166

Product Usage Instructions

Do not manually pull the foot out of the envelope to avoid damage.
To attach the stiffening bumpers, use cyanoacrylate adhesive.
For Pacifica foot (A) and Pacifica LP foot:
- Pacifica Foot with Regular Toe:
- Size: 24-25cm
- Toes: 25 mm
- Pacifica Foot with Sandal Toe (Right):
- Size: 26-28cm
- Toes: 32mm
- Pacifica Foot with Sandal Toe (Left):
- Size: 29-31cm
- Toes: 41mm
Detection of Malfunctions:
- Too Soft Heel
- Too Stiff Heel
- Too Stiff Foot
- Too Soft Foot

INCLUDED ITEMS

Part description	Part number	Included / Sold separately
Pacifica Foot with regular toe	FS2-00-0xAyy-RU*

Included

x = Category, yy = Size (see table §3), zz = Size

DESCRIPTION

Pacifica® and Pacifica® LP are energy-return prosthetic feet 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

Foot	Pacifica – FS2	Pacifica LP – FS4
Side	Right or Left
Size	24 to 25 cm	26 to 28 cm

29 to 31 cm
Sandal toe option| Yes| Yes| No| Yes| Yes| No
Weight| 454 g / 1.0 lbs| 545 g / 1.2 lbs| 705 g / 1.6 lbs| 395 g / 0.9 lbs| 537 g / 1.2 lbs| 746 g / 1.6 lbs
Build height| 65 mm / 2.6‘’| 66 mm / 2.6’’| 70 mm / 2.8‘’| 48 mm / 1.9’’| 54 mm / 2.1’’| 58 mm / 2.3’’
Heel height| 10 mm / 3⁄8”

Based on sizes 23 (Pacifica LP), 24 (Pacifica), 26, 29, cat. 4, with foot shell, Spectra sock and 10 mm heel height
These devices have 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| –| –

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

These medical devices are supplied to healthcare professionals (prosthetists), who will train the patient in their use. The prescription is drawn up by a doctor who assess the patient’s ability to use the device.
These devices are for multiple use on a SINGLE PATIENT. They must not be used on another patient.
The Pacifica 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 deficiency. The Pacifica is particularly suitable for patients with a long residual limb.
This device is indicated for patients with moderate activity levels (K3) for walking and physical activities without excessive overload.
Maximum weight (load carrying included): 166 kg / 365 lbs

CLINICAL BENEFITS

Walking comfort
Reduction of joint impacts

ACCESSORIES AND COMPATIBILITY

Stability on variable terrain
Possible walking on uneven ground
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 illustrations)

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 Pacifica 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)|
---|---|---
Pacifica
24-25 cm| 25 mm / 1’’
26-28 cm| 32 mm / 1,25’’
29-31 cm| 41 mm / 1,6’’
Pacifica LP|

22-25 cm| 32 mm / 1,25’’
26-28 cm| 38 mm / 1,5’’
29-31 cm| 41 mm / 1,6’’

TROUBLESHOOTING

CONCERN	SYMPTOM	SOLUTION

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 devices.
Any serious incident that has occurred in relation to the devices 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 feet are made of carbon fiber composite, epoxy, PU polymers, titanium, and stainless steel. The devices and their packaging must be disposed of in accordance with local or national environmental regulations.

DESCRIPTION OF THE SYMBOLS

|

Manufacturer

| | Identified risk| | CE marking and year of 1 st declaration
---|---|---|---|---|---
| Authorized representative in the European Union| | Single patient, multiple use|

PROTEOR USA

3 Morgan
Irvine, CA 92618 – USA
+1.855.450.7300
[email protected]
www.proteorusa.com
PROTEOR SAS
6 rue de la Redoute
21850 Saint-Apollinaire – France
+33 3 80 78 42 42
[email protected]
www.proteor.com

Documents / Resources

| PROTEOR FS2 Pacifica LP Class 4 Amputated Foot Prosthesis [pdf] Instructions
FS2 Pacifica LP Class 4 Amputated Foot Prosthesis, FS2 Pacifica, LP Class 4 Amputated Foot Prosthesis, 4 Amputated Foot Prosthesis, Foot Prosthesis, Prosthesis
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