PROTEOR AFLEX 2C130 Orthopaedic Prosthetists User Manual

AFLEX 2C130 Orthopaedic Prosthetists
User Manual AFLEX
2C130/2C131(-P)/ 2C16x

COMPONENTS INCLUDED

Designation| Reference| Included/Sold separately|
---|---|---|---
Flexible joints| 2C130 / 2C131 or 2C131-P| Included with assembly kit|
Reinforced joints| 2C160/2C161| Included with assembly kit|
Reinforced and arched
joints| 2C162-XX/2C163-XX
XX = hardness| Included with assembly kit|

DESCRIPTION, PROPERTIES, AND ACTION MECHANISM

A. Description
Complete range of strong, lightweight polyurethane ankle joints, in 3 versions

• Flexible
• Reinforced
• Reinforced and arched, in 3 hardnesses (70, 80, and 90 ShA)

B. Properties

x 14
Centre thickness| 8 mm| 6.5 mm| 5 mm| 9 mm| 9 mm

This device has been tested according to an internal protocol, for 1 million cycles, corresponding to a service life of 1 to 1.5 years, depending on the patient’s mobility.

C. Action mechanism
Their role is to enable:

• Bending of the joint, and connecting the various orthosis shells, in the flexible version
• Bending of the joint, in the reinforced straight version
• Dorsal bending while enabling bending, in the reinforced and arched version, in order to free space for the step.

INTENDED USERS/INDICATIONS

This medical device is supplied to health professionals (orthopedic prosthetists), who will train the patient in their use. The prescription is drawn up by a doctor, alongside the orthopedic 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 part of the thermoformed lower and upper limb external orthosis range.

CLINICAL BENEFITS

The device is recommended for:

• Flexible version: easier-to-wear night-time orthoses, thanks to ankle mobility. These flexible devices improve the comfort of severely spastic patients.

• Reinforced version: walking orthoses, preventing plantar bending of the dropped or spastic foot. Limits varus/valgus movements.
  Counteracts low resistance to dorsal bending movements. Excellent torsion and tensile strength, thanks to their Kevlar reinforcement.

• Reinforced and arched version: At rest, the orthosis is positioned with slight dorsiflexion. In the swing phase of walking, the natural elasticity of the joints forces it back to dorsiflexion, freeing more space for the step. Excellent torsion and tensile strength, thanks to their Kevlar reinforcement.

ACCESSORIES AND COMPATIBILITIES

The device is compatible with thermoformed polypropylene or polyethylene orthoses.
These joints are sold in the form of kits containing: 2 joints, 2 thermoforming tools, 4 screws, 4 nails, 1 washer, and 2 shock-absorbing stops.

MOUNTING AND FITTING ON THE PATIENT

Position the first forming tool on the outer malleolus, and fasten it with nails.
The second tool is positioned and fastened opposite the positive face, with nails.
Plug any spaces between the tool and the positive with plaster filler.
To create the extension shock absorbing stop mount:
Make a block measuring 60 mm x 30 mm x 6 or 8 mm, from the same material as the orthosis. Mark out its position on the plaster.
Position the clean and hot block (170 – 190°C) on the positive, in order to obtain a total thickness and width of more than 10 mm, to accommodate the stop drill holes and chamfer.
Ensure that the block height provides an excess thickness after cutting between 20 and 25 mm.

For thermoforming, use polypropylene or polyethylene.
When thermoforming, mark (without drilling) the screw insertion points.
If thermoforming on Plastazote (PE foam), have the tool raised. Perform thermoforming under vacuum.
Leave to cool down.

Reinforced and arched version:
Before taking the orthosis out of the mold, drill a Ø16 hole (2C162-XX) or Ø13 hole (2C163-XX) to leave a U-shaped anterior countersink.

Mark out the cutting lines on the orthosis, and cut the plastic, leaving the forming tools in place.
Cut the forming tools in their center with a fine blade.
Remove the orthosis from the mold, and take off the leftover parts of the tool.

Reinforced and arched version:
Reduce the posterior part according to the amplitude of the desired plantar bending α.
Polish the edges, adhering to the cutting instructions.
Clear the anterior bending zone of the joint (L=16 for 2C162-XX; L= 13 for 2C163-XX).
Round the edges, to prevent damage to the joint.

Other versions:
Polish the edges, adhering to the cutting instructions.
Grip the lower part of the orthosis.
Drill a Ø D mm hole into the excess thickness, over L mm.
Chamfer using a Ø D’ bit.

Insert the stops, and glue them with cyanoacrylate glue.
Drill the screw insertion holes (Ø V mm) at the depression points left by the forming tool.
Flexible version: Mount the nuts.
Remove the burrs.
Position the joint.

Mount the screws, and tighten them using an Allen key, while holding the nut using the washer provided.
Glue the screws using thread lock glue during final assembly.

DETECTING MALFUNCTIONS

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

WARNINGS, CONTRAINDICATIONS, SIDE EFFECTS

A. Warnings
Using the device in a way that goes against the advice given by your orthopedic prosthetist may cause deterioration of its components (e.g. excessive strain, use beyond the service life, etc.).
B. Contraindications
This device is not intended to be used for activities associated with a risk of significant impact.
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 with a damp cloth or sponge.
No greasing, adjustments to the fasteners or any other operation is required for this device, except by the orthopedic prosthetist.
B. Storage
Usage and storage temperature: -20°C to +60°C
Relative air humidity: no restrictions
C. Disposal
The various components of the device are considered as special waste: stainless steel, polyurethane, polypropylene, polyethylene,
Kevlar. They must be treated in accordance with current, applicable legislation.
D. Service life
It is advisable to arrange for an orthopedic prosthetist to perform an annual check.

DESCRIPTION OF THE SYMBOLS

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

REGULATORY INFORMATION

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

NAME AND ADDRESS OF MANUFACTURER

PROTECTOR 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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