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

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

DANGER
WARNING
CAUTION
NOTICE
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.
Risk of Falling Due to Improper Handling
Inform the patient about the correct use of the system joint and potential dangers especially with regards
to:
- excessive mechanical stress (e.g. due to sports, increased activity or weight gain) and
- unintentional unlocking of the system joint under flexion load.
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Important information about a possible dangerous situation which, if not avoided,
leads to death or irreversible injuries.
Important information about a possible dangerous situation which, if not avoided,
leads to reversible injuries that need medical treatment.
Important information about a possible dangerous situation which, if not avoided,
leads to light injuries that do not need medical treatment.
Important information about a possible situation which, if not avoided, leads to
damage of the product.
DANGER
WARNING