EN
Instructions for Use for Patients Locked System Knee Joints
Страница 1: ...EN Instructions for Use for Patients Locked System Knee Joints ...
Страница 2: ...2 You can find these instructions for use in the download section on our website at www fior gentz com downloads ...
Страница 3: ... 2 Intended Use 4 3 Using the Orthosis 5 3 1 Locking the System Joint 5 3 2 Unlocking the System Joint 5 3 3 Adjusting the Permanent Unlock Function 6 3 4 Releasing the Permanent Unlock Function 6 4 Cleaning the Orthosis 6 5 Maintenance of the Orthosis 6 6 Disposal of the Orthosis 7 7 Signs and Symbols 7 8 CE Conformity 7 9 Legal Information 7 10 Handing Over the Orthosis 8 ...
Страница 4: ...ant 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 1 2 All Instructions for Your Safety D...
Страница 5: ... WARNING Risk of Falling Due to Improper Handling of the Lock Function Have your orthotist or a qualified trained expert inform you about the correct use of the lock function and potential dangers Avoid an unintentional unlocking of the system joint through external influences e g a fall and a forceful unlocking under flexion load Disable the permanent unlock function if you no longer wish to use ...
Страница 6: ...iably it must be locked passively To do this push the knee back with the hand fig 2 Alternatively another person can assist in locking the system joint when you are seated or lying down fig 3 3 2 Unlocking the System Joint To unlock the system knee joint press the locking pawl against the joint s upper part by using the lever extension lock lever or a pulling cable For low effort and minimal wear ...
Страница 7: ...th Leave out the area around the system joint and clean it only superficially with a dry cloth Remove visible dust and lint from the mechanics by using tweezers Check the orthosis in straight and flexed position Mind in particular the locking and unlocking parts 5 Maintenance of the Orthosis Ask your orthotist or a qualified trained expert to check the system joint of your orthosis every 6 months ...
Страница 8: ...note that the product is not supposed to be combined with other components or materials than with those recom mended according to the configuration result from the FIOR GENTZ Orthosis Configurator The combination of the product with products from other manufacturers is not permitted The information in these instructions for use is valid at the date of printing The contained product information ser...
Страница 9: ...lified trained expert they also received the instructions for use for patients The functions and handling of the orthosis were explained in detail by means of these instructions for use Place Date Signature Orthotist or Qualified Trained Expert 10 Handing Over the Orthosis ...
Страница 10: ...men mbH Dorette von Stern Straße 5 21337 Lüneburg Germany info fior gentz de www fior gentz com 49 4131 24445 0 49 4131 24445 57 PB2400 PI 2020 07 Z E R T I FIZIERT CER T I F I E D R e g Nr Q1 0107 0 1 4 DIN EN ISO 9001 Z E R T I FIZIERT CER T I F I E D R e g Nr MQ1 0107 0 1 4 DIN EN ISO 13485 ORTHOSIS SERVICE PASSPORT Have you not yet received an orthosis service passport Ask your orthotist or a ...
