Instructions For Use For Orthotists Or Qualified/Trained Experts System Ankle Joint; Information; Safety Instructions; Classification Of The Safety Instructions - FIOR & GENTZ NEURO SWING H2O Notice D'utilisation

Instructions for Use for Orthotists or Qualified/Trained Experts System Ankle Joint

1.

Information

These instructions for use are addressed to orthotists or qualified/trained experts and do not contain any notes
about dangers which are obvious to them. To achieve maximum safety, please instruct the patient and/or care
team in the use and maintenance of the product.
2.

Safety Instructions

2.1

Classification of the Safety Instructions

Important information about a possible dangerous situation which, if not avoided,
DANGER
leads to death or irreversible injuries.
Important information about a possible dangerous situation which, if not avoided,
WARNING
leads to reversible injuries that need medical treatment.
Important information about a possible dangerous situation which, if not avoided,
CAUTION
leads to light injuries that do not need medical treatment.
Important information about a possible situation which, if not avoided, leads to
NOTICE
damage of the product.
All serious incidents according to Regulation (EU) 2017/745 which are related to the product have to be
reported to the manufacturer and to the competent authority of the Member State in which the orthotist or
qualified/trained expert and/or the patient is established.
2.2

All Instructions for a Safe Handling of the System Ankle Joint

Potential Traffic Accident Due to Limited Driving Ability
Advise the patient to gather information about all safety and security issues before driving a motor vehicle
with orthosis. The patient should be able to drive a motor vehicle safely.
Risk of Falling Due to Improper Handling
Inform the patient about the correct use of the system joint and possible dangers, especially with regards
to excessive mechanical stress (e.g. due to sports, increased activity or weight gain).
Risk of Falling Due to Improper Processing
Process the system joint according to the information in these instructions for use. Deviating processing
and modifications of the system joint require the written consent of the manufacturer.
DANGER
WARNING
WARNING
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