PROTEOR 1A101 Dynastep Carbon Foot Instruction Manual
- June 4, 2024
- PROTEOR
Table of Contents
- PROTEOR 1A101 Dynastep Carbon Foot
- COMPONENTS INCLUDED
- DESCRIPTION, PROPERTIES AND MECHANISM OF ACTION
- INTENDED USERS/INDICATIONS
- CLINICAL BENEFITS
- ACCESSORIES AND COMPATIBILITIES
- ASSEMBLY AND FITTING TO THE PATIENT
- DETECTING ANY MALFUNCTIONING
- WARNINGS, CONTRAINDICATIONS, SIDE EFFECTS
- MAINTENANCE, STORAGE, DISPOSAL AND SERVICE LIFE
- DESCRIPTION OF THE SYMBOLS
- REGULATORY INFORMATION
- NAME AND ADDRESS OF MANUFACTURER
- References
- Read User Manual Online (PDF format)
- Download This Manual (PDF format)
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
cs@proteor.com –
www.proteor.com
References
Read User Manual Online (PDF format)
Read User Manual Online (PDF format) >>