PROTEOR ROM-00-0xAyy-RU Lower Extremity Prostheses Instruction Manual

PROTEOR ROM-00-0xAyy-RU Lower Extremity Prostheses

Product information

size 26 to 28 cm), 961 g / 2.1 lbs (for size 29 to 31 cm)
build height*| 119 mm / 4.7” (for size 22 to 25 cm), 120 mm / 4.7” (for size
26 to 28 cm), 124 mm / 4.9” (for size 29 to 31 cm)
Heel height| 10mm / 3/8″

Based on sizes 23, 26, and 29, category 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 125 kg for 2 million cycles.

Product Usage Instructions

1. Ensure that the following items are included:
   • Kinterra foot & ankle system with regular toe (ROM-00-0xAyy-RU*)
   • Kinterra foot & ankle system with sandal toe (ROM-00-0xAyy-Sv*)
   • Black Spectra socks (S0-NPS-200yy-00*)
   • Stiffening bumpers (KIT-00-1133U-00)
   • Foot shell with regular toe (no cap) (FTC-3M-1yy-t4-Rv*) – sold separately
   • Foot shell with sandal toe (no cap) (FTC-2M-1yy-t4-Sv*) – sold separately (see catalogue)
   • 2. Select the appropriate size based on the patient’s foot measurements.
2. If the sandal toe option is available, choose whether to include it or not based on the patient’s preference.
3. Assemble the foot and ankle system according to the provided instructions.
4. Ensure that the weight and activity level of the patient falls within the recommended range for the selected foot category.
5. Follow the alignment instructions for proper alignment of the foot and ankle system.
6. If necessary, adjust the resistance of the foot and ankle system by increasing or decreasing the size of the dot.
7. Ensure that the foot shell, Spectra sock, and heel height are appropriate for the patient’s needs.
8. Clean the foot and ankle system regularly according to the provided cleaning instructions.
9. Store and dispose of the product properly, following the recommended environmental conditions and disposal guidelines.
10. Refer to the user manual for a detailed description of the symbols used on the product.

INCLUDED ITEMS

Part description| Part number| Included / Sold separately
---|---|---
Kinterra foot & ankle system with regular toe| ROM-00-0xAyy-RU| Included
Kinterra foot & ankle system with sandal toe| ROM-00-0xAyy-Sv
Black Spectra sock| S0-NPS-200yy-00| Suitable sock included
Stiffening bumpers| KIT-00-1133U-00| Included
Foot shell with regular toe (no cap)| FTC-3M-1yy-t4-Rv| Sold separately (see catalogue)
Foot shell with sandal toe (no cap)| FTC-2M-1yy-t4-Sv*

• x = Category, yy = Size (see table §3), v = Side, t = Skin Tone (light, medium, dark)

DESCRIPTION

Kinterra® is a foot-ankle system consisting of:

• A hydraulic ankle with dorsi-assist spring
• An EnduraCore® foot module
• 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 125 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| 256-275
kg| 44-52| 53-59| 60-68| 69-77| 78-88| 89-100| 101-116| 117-125
Activity level| Low| 1| 1| 2| 3| 4| 5| 6| 7
Moderate**| 1| 2| 3| 4| 5| 6| 7| –

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

MECHANISM OF ACTION

At heel strike, the EnduraCore® 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 midstance. Once full hydraulic dorsiflexion is reached, EnduraCore 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 drawn up 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 congenital limb 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): 125 kg / 275 lbs (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 of 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 catalogue).

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 low 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

  • If 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 12 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 system must have 2° dorsiflexion and 10° plantarflexion

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

Dynamic Alignment
Adjust the hydraulic valves carefully to balance the comfort provided by the hydraulic ankle and the 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. Due to the posterior placement of Kinterra’s ankle pivot point, changes to the plantar flexion 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 (PF) using a 4 mm Allen wrench (see illustration on the right):
  • 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 (DF) using a 4 mm Allen wrench:
  • If the patient feels they are walking downhill, increase dorsiflexion resistance
  • If the effort to advance over the foot (tibial progression) is challenging for the patient, decrease dorsiflexion 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 the 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 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| 22 mm / 0,9’’
26-28 cm| 30 mm / 1,2’’
29-31 cm| 38 mm / 1,5’’

TROUBLESHOOTING

• Sinking at heel strike, ‘crushing’ the heel
• Difficult to progress the step from heel strike to midstance
• The feeling of walking uphill or forefoot feels too long

|

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

Heel too hard|

• Rapid knee flexion moment, instability at heel strike

|

• Check anteroposterior alignment, ensure foot is not positioned too far posterior

 |

• Lack of energy return sensation at heel strike

|

• Reduce the plantarflexion resistance

---|---|---
Foot module is  too stiff|

• Flat spot in rollover motion at slow cadences

|

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

Foot module is  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.
• Never use the foot without a foot shell and a Spectra sock.
• Never loosen the pyramid fastening screws.
• The patient must practice driving, sitting and standing with the Kinterra in a safe place to ensure they adjust to the plantar and dorsiflexion movements provided by the ankle.
• 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 and the foot shell to wear out. Clean the foot according to the instructions (see §16).
• 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.
• 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 125 kg / 275 lbs
• 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 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 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: -28 to +50°C
• Relative air humidity: no restrictions

Avoid use in water, as prolonged exposure to moisture may damage the product. After use in water or if splashed by a liquid, the foot including its foot shell must be cleaned and dried (see §16).

DISPOSAL
The foot is made of EnduraCore® carbon fiber and fiberglass composite, aluminum, stainless steel, titanium, epoxy resin, polymers, and hydraulic fluid. 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 1 st declaration
---|---|---|---|---|---
| Authorized representative in the European Union| | Single-patient, multiple uses|

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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