PROTEOR DYNASTEP Instrucciones De Uso página 6

6. ASSEMBLY AND FITTING TO THE PATIENT
A. 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).
B. 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.
C. Finishing
Comply with traditional good professional practices in terms of fitting the malleolar clip to cosmetic
elements.
7. 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.
8. WARNINGS, CONTRAINDICATIONS, SIDE EFFECTS
A. 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.
B. 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.
C. 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.
9. MAINTENANCE, STORAGE, DISPOSAL AND SERVICE LIFE
A. 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, 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.
B. Storage
Service and storage temperature: -20°C to +60°C
Relative humidity of the air: no restrictions
C. Disposal
The various components of the foot are considered as special waste: fibre glass, epoxy resin, polyurethane foam. They must be
treated in accordance with current, applicable legislation.
INSTRUCTIONS FOR USE Page 2 of 3
Centre of
coxofemoral
joint
Load line
Centre of
knee joint
Knee fully
Normal
extended
heel
height
= 10 mm