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Report Of Serious Incident - Össur PRO-FLEX ST Gebruiksaanwijzing

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  • DUTCH, pagina 54
USAGE
Cleaning and care
Clean with a damp cloth and a mild soap. Dry with a cloth after cleaning.
Environmental Conditions
The device is Waterproof.
A Waterproof device can be used in a wet or humid environment and
submerged in up to 3-meter-deep water for a maximum of 1 hour.
It can tolerate contact with: Salt water, chlorinated water, perspiration,
urine, and mild soaps.
It can also tolerate occasional exposure to sand, dust, and dirt.
Continuous exposure is not allowed.
Dry with a cloth after contact with fresh water or humidity.
Clean with fresh water and dry with a cloth after exposure to other liquids
and chemicals or in case of accidental exposure to sand, dust, or dirt.
MAINTENANCE
The device and the overall prosthesis should be examined by a healthcare
professional. Interval should be determined based on patient activity.
Noise from Foot
Noise may occur if sand or debris is present in device. In that case, the
healthcare professional should doff the foot, clean it with the help of
compressed air and replace the Spectra sock if it is damaged.

REPORT OF SERIOUS INCIDENT

Any serious incident in relation to the device must be reported to the
manufacturer and relevant authorities.
DISPOSAL
The device and packaging must be disposed of in accordance with
respective local or national environmental regulations.
LIABILITY
Össur does not assume liability for the following:
• Device not maintained as instructed by the instructions for use.
• Device assembled with components from other manufacturers.
• Device used outside of recommended use condition, application, or
environment.
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