PROTEOR AFLEX 2C162 Serie Notice D'utilisation page 8

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 threadlock glue during final assembly.
7. DETECTING MALFUNCTIONS
If you observe abnormal behaviour or feel modifications in the device's properties, or if it undergoes a heavy impact, please consult your
orthopaedic prosthetist.
8. WARNINGS, CONTRAINDICATIONS, SIDE EFFECTS
A. Warnings
Using the device in a way that goes against the advice given by your orthopaedic prosthetist may cause deterioration of its components
(e.g. excessive strain, using 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.
9. 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 orthopaedic 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 orthopaedic prosthetist to perform an annual check.
10. DESCRIPTION OF THE SYMBOLS
Manufacturer
11. REGULATORY INFORMATION
This product is a CE marked medical device, and certified compliant with Regulation (EU) 2017/745
USER MANUAL
Risk identified
st
CE marking and year of 1 declaration
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