PROTEOR RM3 Kinterra Foot Instruction Manual

PROTEOR RM3 Kinterra Foot

INCLUDED ITEMS

Catalogue)

• x = Category, yy = Size, z = Side, t = Skin Tone (light, medium, dark)

DESCRIPTION

Kinterra is a foot-ankle system consisting of:

• A hydraulic ankle with dorsi-assist spring
• An Endura Core® foot module
• A male pyramid connection
• A black spectra sock

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

PROPERTIES

• Based on a 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 150 kg for 2 million cycles.

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

*Weight _)_| lb| 100-115| 116-130| 131-150| 151-170| 171-195| 196-220| 221-255| 256-290| 291-330
kg| 44-52| 53-59| 60-68| 69-77| 78-88| 89-100| 101-116| 117-132| 133-150
Impact Level| Low| 1| 1| 2| 3| 4| 5| 6| 7| 8
Moderate**| 1| 2| 3| 4| 5| 6| 7| 8| –

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

MECHANISM OF ACTION

At heel strike, the Endura Core heel compresses to store energy, and the hydraulic ankle plantarflexes to reach foot flat depending on the angle of the terrain. Once foot flat is reached, the hydraulic ankle allows tibial progression to 2° of dorsiflexion and the heel compression energy is returned mid stance. Once full hydraulic dorsiflexion is reached, Endura Core foot module deflection begins to store energy. This energy is then returned at toe off.

INTENDED USE/INDICATIONS

 This medical device is supplied to healthcare professionals (prosthetists), who will train the patient in its use. The prescription is provided by a doctor who assesses 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 and ankle in patients with unilateral or bilateral lower limb amputation and/or deficiencies (transtibial/transfemoral amputation, knee/hip disarticulation, congenital limb deficiencies).
Caution should be used when fitting bilateral patients due to added movement of the ankle.
This device is indicated for patients with moderate activity level (K3) for walking and low to moderate impact activities.
Maximum weight (load carrying included): 150 kg / 330 lb (See table §3)

CLINICAL BENEFITS

• Increased step length and gait symmetry
• Increased swing phase toe clearance
• Improved sitting comfort
• Improved comfort and safety on uneven terrain
• Improved comfort and control descending ramps
• Improved knee stability

ACCESSORIES AND COMPATIBILITY

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

ALIGNMENTS

Bench Alignment

Before fitting the prosthesis on the patient, with the foot shell installed and a 3/8” (10 mm) lift under the heel, or preferably placed in the desired shoe, use a plumb line or laser level to confirm that the load line falls along the anterior edge of the pylon and pyramid (see illustration).

Static Alignment

• Set the hydraulic valves to highest resistance.

• Ask the patient to stand between parallel bars with weight evenly distributed. The patient should be able to stand comfortably without feeling as if the knee is flexing or hyperextending. The weight line should fall along the anterior edge of the pylon and pyramid.

  •  the knee is flexing, shift the foot anteriorly.
  • If the knee is hyperextending, shift the foot posteriorly.
    Angular adjustment of the pyramid will impact the ratio of the 17 degrees range of motion. Plantarflexing at the pyramid will decrease the dorsiflexion range of motion and dorsiflexing at the pyramid will increase the plantarflexion range of motion.
    Ensure that the range of dorsiflexion and plantarflexion motion is maintained when flexion is properly accommodated. The ankle is intended to have 2° dorsiflexion and 15° plantarflexion.

• After at least a 10 minute acclimation period, proceed to valve resistance adjustments.

Dynamic Alignment

Adjust the hydraulic valves carefully to balance the comfort provided by the hydraulic ankle and energy return provided by the foot module. Higher resistance will allow the carbon fiber to be loaded more and provide more energy return. Lower resistance will allow more ankle motion and comfort while sitting and ambulating on slopes and uneven terrain.
Changes to the plantarflexion and dorsiflexion resistance settings will be most noticeable to the patient when they are walking on slopes. Adjustments of the resistances are best done on a gradual slope as a final step in dynamic alignment.

• Observe the patient walking between parallel bars.

• Adjust plantarflexion resistance (P) using a 4 mm Allen wrench (see illustration below):

  • If there is foot slap or heel strike is too abrupt, increase plantarflexion resistance.
  • If the heel is too firm or the knee is buckling at heel strike, decrease plantarflexion resistance.

• In the same way, adjust dorsiflexion resistance (D) using a 4 mm Allen wrench:

  • If the patient feels they are walking downhill, increase dorsiflexion resistance.
    INSTRUCTIONS FOR USE

  • If the effort to advance over the foot (tibial progression) is challenging for the patient, decrease dorsiflexion resistance.
    
    Smaller Dot = Lower Resistance   |    Larger Dot = Higher Resistance
    

ASSEMBLY

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 EnduraCore foot module before mounting the foot shell.

Foot shell

To install and remove the foot shell, use a foot shell removal tool to prevent damage of the foot module.

 Never remove the foot from the foot shell by pulling manually. Never use a screwdriver or any other inappropriate instrument to remove it. This could damage the foot.

ADJUSTMENTS

The heel stiffness at heel strike 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 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)|
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22-25 cm| 32 mm / 1.25’’
26-28 cm| 38 mm / 1.5’’
29-30 cm| 48 mm / 1.9’’

TROUBLESHOOTING

• Sinking at heel strike, ‘crushing’ the heel.
• Difficult to progress the step from heel strike to midstance.

|

• Check anteroposterior alignment, ensure foot is not positioned too far anterior.
• Increase plantar flexion resistance.
• Attach heel stiffening bumpers. See section 10 above for installation details

Heel too hard|

• Rapid knee flexion moment, instability at heel strike.
• Lack of energy return sensation at heel strike.

|

• Check anteroposterior alignment, ensure foot is not positioned too far posterior.
• Reduce plantar flexion resistance.

Foot module too stiff|

• Flat spot in rollover motion.
• Difficult to progress over toe.

|

• Assess true impact level (low or moderate).
• Consider a lower category foot module.

Foot module too soft|

• Clicking noise at initial contact.
• Excessive toe deflection.

|

• Assess true impact level (low or moderate).
• Consider a higher category foot module.

WARNINGS

 In case of damaged packaging, check the integrity of the device.
 Failure to follow the instructions for use is dangerous and will void the warranty.
 Advise users to practice driving, sitting, and standing with the Kinterra in a safe place to ensure they adjust to the plantar and dorsiflexion movement provided by the ankle.
 Never use the foot module without a foot shell and a spectra sock. Failure to comply may cause premature wear, loss of function, and/or product failure.
 Always use the foot module with a shoe. Failure to comply may cause premature wear, loss of function, and/or product failure.
 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 and the foot shell to wear out. Clean the foot according to the instructions (see §16).
 Never attempt to loosen the bolts affixing the ankle to foot.
If the patient notices any abnormal behavior or feels 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.
 The patient must inform their prosthetist if they lose or gain weight.
 Avoid prolonged use in water. Extended exposure to moisture may have a negative impact on the life of the product.
 After use in water, completely dry the foot, including its foot shell.
 Avoid prolonged use in salt or chlorinated water. Extended exposure to these environments may have a negative impact on the life of the product. After use in these environments, the foot including its foot shell must be cleaned and dried (see §16).

CONTRAINDICATIONS

 Use for a patient whose maximum weight (load carrying included) may exceed 150 kg / 330 lb.
 Use for K4 patient or 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 wear of the foot module. 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 soap and clear water and dry carefully. The foot shell can be cleaned with a damp cloth or sponge. It must be dried before reuse.
 The device is not resistant to solvents. Exposure to solvents may cause damage.

ENVIRONMENTAL CONDITIONS

Temperature range for use and storage: -29°C to +49°C [-20°F to 120°F] Relative air humidity: no restrictions
Water-resistance: Occasional submersion in fresh water for maximum 30 minutes in 1 m of water. Not recommended for a shower prosthesis.

DISPOSAL

The device is made of carbon fiber and other composite fibers, aluminum, titanium, stainless steel, hydraulic fluid, rubber, and epoxy. The foot shell is made of thermosetting polymer material. The device and its 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 1st declaration
---|---|---|---|---|---
| Authorized representative in the European Union| | Single patient, multiple us e|

REGULATORY INFORMATION

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

| Kinterra® – RM3 Instructions for use for prosthetists Read before use| IFU-02-005 Rev. A 2023-05
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Pass on § 12, 13, 14, 15, 16, 17, and 18 of these instructions to the patient.

Customer Support

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

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