Instructions for Use for Patients System Ankle Joints
Instructions for Use for Patients
System Ankle Joints
Dear Patient,
You have received an individually produced orthosis with a high quality FIOR & GENTZ system ankle joint from
your orthotist or a qualified/trained expert.
1.
Safety Instructions
1.1
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.
1.2
All Instructions for Your Safety
Potential Traffic Accident Due to Limited Driving Ability
Gather information about all issues concerning safety and security and potential dangers before driving a
motor vehicle with orthosis.
Risk of Falling Due to Loosened Screws
Do not secure the screws for the system joint on your own. Consult your orthotist or a qualified/trained
expert about the maintenance intervals to be respected.
10
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