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Instructions for Use for Orthotists or Qualified/Trained Experts System Ankle 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 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
Important information about a possible dangerous situation which, if not avoided,
leads to death or irreversible injuries.
WARNING
Important information about a possible dangerous situation which, if not avoided,
leads to reversible injuries that need medical treatment.
CAUTION
Important information about a possible dangerous situation which, if not avoided,
leads to light injuries that do not need medical treatment.
NOTICE
Important information about a possible situation which, if not avoided, leads to
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.
fig. 1
For a simplified illustration, all work steps are shown with the
NEURO VARIO-SWING
system ankle joint (fig. 1) as an example.
They can be transferred to all mentioned system joints.
