PROTEOR 1A101 Dynastep Carbon Foot Instruction Manual

PROTEOR 1A101 Dynastep Carbon Foot

COMPONENTS INCLUDED

DESCRIPTION, PROPERTIES AND MECHANISM OF ACTION

Description
An energy-returning, prosthetic foot that offers comfort to patients active on normal or uneven terrain, consisting of:

• A polyurethane foam foot shell 1 overmoulded around two composite blades 2 and 3, with a sandal toe,
  • A split, forefoot blade made of fibre glass and epoxy resin 2,
  • A C-shaped rear blade (3),
• A malleolar clip,
• A hole through the heel for a screw used to secure an ankle base.

Properties

This device has undergone a two-million-cycle test, in accordance with standard NF EN ISO 10328 (at a P4 load level for the 80 kg version and at P5 for the 100 kg version), which corresponds to a service life of 2 to 3 years, depending on the patient’s activity level.

INTENDED USERS/INDICATIONS

This medical device is supplied to healthcare professionals (prosthetists/orthotics) who then instruct the patient in how to use it. The prescription is drawn up by a doctor. The doctor works with a prosthetist/orthotist to assess whether the patient is suited to using the device. This device should be used on ONE PATIENT ONLY. It must not be reused on other patients.

This device is exclusively intended to be used as orthopedic equipment for a below-knee or above-knee amputee whose activity level is low-medium (2). Maximum weight (including carried load):

• Sizes 22 to 25: 80 kg
• Sizes 26 to 29: 100 kg

Designed to accommodate a heel height of 5 to 15 mm.

CLINICAL BENEFITS

The device increases an amputee’s walking range thanks to the energy efficiency generated by the two foot blades that also allow the patient to walk on a range of surfaces.

ACCESSORIES AND COMPATIBILITIES

Can be connected to any A type ankle base fitted with an M10 screw (A1) (Refer to our catalogue). The heel height can be adjusted from 5 to 15 mm.

ASSEMBLY AND FITTING TO THE PATIENT

Assembly
Place a block under the foot whose thickness corresponds to the height of the shoe’s heel. For example, attach the male pyramid base to the foot. Tighten to the tightening torque specified for the M10 screw (A1).
Aligning
Align the device such that the load line passes through the posterior of the foot, 1/3rd of the length from the back.
Comments:

• For a more dynamic alignment, increasing the plantar flexion improves the energy return at step completion.
• If, during roll-over, the patient feels that their foot is too long, or if the heel contact is too soft, the foot should be moved in the posterior direction with respect to the socket.
• If, during roll-over, the patient feels that their foot is too short, or if the heel contact is too rigid, the foot should be moved in the anterior direction with respect to the socket.

The dynamic alignment is performed in accordance with good professional practices.
Finishing
Comply with traditional good professional practices in terms of fitting the malleolar clip to cosmetic elements.

DETECTING ANY MALFUNCTIONING

If you notice that the device is behaving abnormally or if its characteristics feel different, or if it has been badly knocked, consult your prosthetist/orthotist.

WARNINGS, CONTRAINDICATIONS, SIDE EFFECTS

Warnings
Using the foot in a way that goes against the advice given by your prosthetist/orthotist may damage or degrade the foot’s components (e.g. carrying heavy loads, excessive stresses, use after its service life has expired, etc.) The device is weatherproof only.
Contraindications
This foot is not intended to be used for activities associated with a risk of significant impact or excessive loading. This foot is not resistant to fresh water, salt water or chlorinated water.
Side effects
There are no side effects directly associated with the device. Any serious incident that occurs which relates to the device must be reported to the manufacturer and to the competent authority of the member state in which the incident occurred.

MAINTENANCE, STORAGE, DISPOSAL AND SERVICE LIFE

Maintenance/cleaning
Clean the foot shell with a damp cloth or sponge. All work on the foot should be performed by the prosthetist/orthotist; no other operations, such as lubrication, work on the fastenings or other work, that need to be performed.
After accidental contact with water:

• Rinse the foot with clean water
• Dry thoroughly

The malleolar clip may need to be replaced.
Storage
Service and storage temperature: -20°C to +60°C Relative humidity of the air: no restrictions
Disposal
The various components of the foot are considered as special waste: fiberglass, epoxy resin, and polyurethane foam. They must be treated in accordance with current, applicable legislation.

Service life
It is advisable to arrange for a prosthetist/orthotist to check the product once a year.

DESCRIPTION OF THE SYMBOLS

REGULATORY INFORMATION

This product is a CE-marked medical device that is certified as conforming 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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