Instructions For Use For Orthotists Or Qualified/Trained Experts System Knee Joints; Information; Safety Instructions; Classification Of The Safety Instructions - FIOR & GENTZ NEURO LOCK Notice D'utilisation

Instructions for Use for Orthotists or Qualified/Trained Experts System Knee Joints

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 orthotists or qualified/trained experts. To achieve maximum safety, please
instruct the patient and/or care team in the use and maintenance of the product.
For a simplified illustration, all work steps are shown with the NEURO FLEX MAX system
knee joint with lock function (fig. 1) as example. They can be transferred to all mentioned
system joints.
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 Knee 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.
DANGER
fig. 1
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