Allard Meracus 29000 Mode D'emploi page 7

Information
Any serious incident that may occur in relation to the
device should be reported to the manufacturer and the
competent authority of the Member State in which the
user and / or patient is established.
Disposal
To be disposed in accordance with local legislations.
Warnings
The prosthetist or equivalent medical professional must
review the following information directly with the user:
• Meracus is tested and approved according to ISO 22675
and should be used together with standardized adult-
size components. It is the fitter's responsibility to ensure
safe combinations of componentry in the final prosthetic
device.
• Do not allow debris or liquid remain inside the foot shell.
If the prosthesis is exposed to such, remove the foot
shell and the protective sock and rinse immediately with
fresh water and dry properly.
• The prosthetic foot should be inspected by clinicians
every six months to detect any signs of abnormal wear
and to check that the screws are secured.
• If any changes or modifications are made to the product
that are not described in the Professional Instructions,
the product responsibility passes entirely to the person
making the changes.
• The product should not be used for activities where
there is a risk of being exposed to exceptional loads. Not
suitable for high impact sports.
Meracus Prosthetic Foot
• Evaluate the ability to drive or operate heavy machinery.
It is important to consider that a prosthetic device may
create hazards not present with an intact limb.
• The prosthetic foot must always be used with a Spectra
sock and a foot shell. The Spectra sock protects the foot
shell and composite from wear.
• The prosthetic foot can be slippery when used without a
shoe, such as when showering/ bathing.
• If the properties of the prosthetic foot suddenly change,
or if an abnormal noise is heard from the prosthetic foot,
the fitter must be contacted immediately, and the foot
must not be used.
EN
7