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14.
SIDE EFFECTS
There are no known side effects directly associated with the device.
Any serious incident that has occurred in relation to the device should be reported to the manufacturer and to the competent
authority of the Member State in which the user is established.
15.
MAINTENANCE AND CONTROL
The foot module must be inspected by the prosthetist at least every six months. Inspections at shorter intervals are required if the
user is more active.
The Spectra sock and the foot shell must be replaced by the prosthetist at regular intervals, depending on the patient's level of
activity. If these parts are damaged, it can lead to premature foot wear.
The lifetime of the foot depends upon the patient's level of activity.
16.
CLEANING
Remove the foot shell and the Spectra sock, clean the foot with clear water and neutral soap and dry carefully.
The foot shell can be cleaned with a damp cloth or sponge.
The device is not resistant to solvents. Exposure to solvents may cause damage.
17.
ENVIRONMENTAL CONDITIONS
Temperature range for use and storage: -29 to 49°C [-20 to 120° F]
Relative air humidity: no restrictions
Water-resistant: the device is resistant to occasional immersion and splashes.
The foot shell is not resistant to ultraviolet light (UV). Do not store it under direct sunlight.
18.
DISPOSAL
The foot is made of carbon fiber composite, epoxy, titanium, stainless steel, and rubber
disposed of in accordance with local or national environmental regulations.
19.
DESCRIPTION OF THE SYMBOLS
Manufacturer
Authorized representative
in the European Union
20.
REGULATORY INFORMATION
This product is a CE-marked medical device and is certified as conforming with Regulation (EU) 2017/745.
INSTRUCTIONS FOR USE
Identified risk
Single patient, multiple
use
. T
he device and its packaging must be
CE marking and year of
st
1
declaration
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IFU-01-097
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