PROTEOR 1A920 Lame Easy Run Module Instruction Manual

PROTEOR 1A920 Lame Easy Run Module

COMPONENTS INCLUDED

DESCRIPTION, PROPERTIES AND ACTION MECHANISM

A. Description
Blade comprising the following components:

• C-blade able to store and return energy
• Strip with radius of curvature optimised for running
• Sole for good ground contact and wear resistance
• Rotatable male pyramid connector

B. Properties

Maximum patient weight

(Including load borne)

| ****

110 kg

Category selection guide

 | Patient weight (kg)
Activity| 40- 49| 50- 59| 60- 69| 70- 79| 80- 89| 90- 99| 100- 110
Moderate impact: Jogging| –| 1| 2| 3| 4| 5| 6
High impact: Running| 1| 2| 3| 4| 5| 6| –

Design height: 220 mm.

INTENDED USERS/INDICATIONS

This medical device is supplied to health professionals (orthopaedic prosthetists), who will train the patient in their use. The prescription is drawn up by a doctor, alongside the orthopaedic prosthetist, to assess whether the patient is suited to using it.
This device is for SINGLE-PATIENT use. It must not be reused on another patient.

This device is designed to be mounted preferably on the tibial socket or agenesis, but can still be mounted on the femoral socket for individuals with a high activity level (4).

Maximum weight (including load borne): 110 kg

CLINICAL BENEFITS
The device will enable an amputee to exercise (jogging or running), thanks to its shock absorption and energy return functions.

ACCESSORIES AND COMPATIBILITY

MOUNTING AND FITTING ON THE PATIENT

A. Alignments

Preparation:
Trace the load lines and knee joint centre on the socket.

Alignment in sagittal plane:
The load line must run through the knee joint centre marked on the socket, and 60 to 70 mm back from the blade contact point with the ground.
The knee-ground mounting height must be 30 to 50 mm more than the height on the patient (including shoe).
No flexum. If the patient has genuine flexum, this must be respected.

Alignment in frontal plane:
The construction line must run via the middle of the socket and the middle of the blade (the blade must have a few degrees’ external rotation).

Finishing:
After setting and alignment, glue the screws (XC047 medium threadlock), and torque tighten to 6 Nm.

B. Alignments (with the patient)

1. Jumping from one foot to the other: the blade must press flat on the ground (frontal view).

2. Hopping: the blade must drive upwards (not to the front or rear). If necessary, modify the blade angle. In every case, the patient must feel that their knee is free-moving and easy to control (no hyperextension caused when the blade is pressed on the ground).

3. Running tests: the objective is to limit muscle and ligament stress, and reduce the patient’s energy consumption. To do so, you can adjust the height, and the frontal and sagittal angles, according to how the patient feels. The aim is to obtain stride symmetry at the patient’s running speed.

   • Feeling of sinking, too much give: the blade module is probably too flexible. Check when the patient is running with small strides on an upward slope; if there is no reaction force, the blade is too flexible.
     Action: replace the module. For a fine adjustment, you can move the blade forward in relation to the socket.

   • Patient feeling impacts, discomfort: the blade module is probably too stiff.
     Action: replace the module. To fine-tune, you can move the blade backward in relation to the prothesis.

   • Patient feeling outward or inward tilting of the prothesis: the blade is probably too far inward or outward.
     Action: incline it in the direction of the valgum/varum, or shift it across.

   • Patient experiences falling sensation before contact (shoulder dropping): The prothesis is probably too short.
     Action: increase the height of the prothesis.

   • Patient feeling difficulty striding: the prothesis is probably too long.
     Action: decrease the height of the prothesis.

C. Setting the pyramidal connector
Modifying the orientation of the pyramid, or replacing the connector:

• Loosen or remove the connector.
• Adjust the orientation, and then refit or retighten, applying some threadlock glue on the taps of the lower connector.
• Torque tighten to 6 Nm.

DETECTING MALFUNCTIONS
If you observe abnormal behaviour or feel modifications in the device’s properties, or if it undergoes a heavy impact, please consult your orthopaedic prosthetist.

WARNINGS, CONTRAINDICATIONS, SIDE EFFECTS

A. Warnings

• Using the device in a way that goes against the advice given by your orthopaedic prosthetist may cause deterioration of its components (e.g. bearing heavy loads, excessive strain, using beyond the service life, etc.).
• No greasing, adjustments to the fasteners or any other operation is required, except by the orthopaedic prosthetist.
• There are specific risks due to lower limb amputation (falls, trophic disorders of the residual limb through conflict with the prothesis socket, etc.). Running training with an orthopaedic prosthetist, physiotherapist or parasports club is essential.
• Running on a conveyor belt may is only permissible with in-person monitoring, and not as part of solo training.
• Check the whole prothesis whenever it has been used (screwed joint, no perceptible gap).
• Do not modify the product (trimming or drilling, etc.)
• Do not heat up the blade with a hot air gun, do not machine the blade to reduce its cross-section, and do not sand the blade too heavily when replacing the sole (risk of removing the upper carbon layer).
• Do not expose the prothesis to a flame or powerful heat source (radiator, etc.)
• The device is resistant to soft, salty and chlorinated water, provided that the care instructions are followed (§9.A).

B. Contraindications

• This device is not designed for activities with an excessive overload risk or jumps from significant heights, for example.
• Adhere to the exercise instructions (running, jogging) when using the product
• Do not use the product without the sole provided, or if it is detached or damaged.

C. Side effects
There are no side effects directly linked to the device.
Any serious incident arising in relation to the device must be reported to the manufacturer and to the competent authority of the Member State.

CARE, STORAGE, DISPOSAL AND SERVICE LIFE

A. Care/ cleaning
Clean the envelope with a damp cloth or sponge.
No greasing, adjustments to the fasteners or any other operation is required for this blade, except by the orthopaedic prosthetist.

• After use in water:

• Rinse the blade in clear water

• Dry thoroughly
  The presence of sand, particles or foreign bodies inside the foot could modify its behaviour and damage it. After use in a very dirty environment:

• Rinse the blade and other parts in clean water, in order to eliminate the particles.

• Dry the various components.
  The sole and under-layer may require replacement by the orthopaedic prosthetist: green kit (1A92013-1) or black kit (1A92013-2)
  Detach the sole, and clean the glued surface (do not use any solvent, to avoid ruining the aesthetics of the strip).
  Manually sand the surfaces before gluing the under-layer onto the strip, and do the same to glue the sole on the under-layer (XC090 neoprene glue).

B. Storage
Usage and storage temperature: -10°C to +40°C
Relative air humidity: no restrictions

C. Disposal
The various components of the blade are special waste: Elastomer, epoxy resin- based composite, titanium, stainless steel. They must be treated in accordance with the locally applicable legislation.

D. Service life
It is advisable to arrange for an orthopaedic prosthetist to perform an annual check.

DESCRIPTION OF THE SYMBOLS

**| Manufacturer| **| Risk identified| **| CE marking and year of 1 st   declaration**
---|---|---|---|---|---

REGULATORY INFORMATION
This product is a CE marked medical device, and certified compliant with Regulation (EU) 2017/745

NAME AND ADDRESS OF MANUFACTURER PROTEOR SAS
6 rue de la Redoute – 21850 Saint-Apollinaire – France
Tel.: +33 3 80 78 42 42 – Fax: +33 3 80 78 42 15
[email protected] – www.proteor.com

References

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