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Summary of Contents for FIOR & GENTZ NEURO LOCK Carbon
- Page 1 Instructions for Use for Patients System Knee Joint NEURO LOCK Carbon...
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Page 2: Table Of Contents
Content Page Instructions for Use for Patients System Knee Joint NEURO LOCK Carbon Safety Instructions 1.1 Classification of the Safety Instructions 1.2 All Instructions for Your Safety 2.1 Intended Use 2.2 Indication 2.3 Contraindication 2.4 Qualification 2.5 Application Using the Orthosis 3.1 Locking the System Joint 3.2 Unlocking the System Joint 3.3 Adjusting the Permanent Unlock Function 3.4 Releasing the Permanent Unlock Function... -
Page 3: Instructions For Use For Patients System Knee Joint Neuro Lock Carbon
Instructions for Use for Patients System Knee Joint NEURO LOCK Carbon Dear Patient, You have received an individually produced orthosis with a high quality FIOR & GENTZ system knee joint from your orthotist or a qualified/trained expert. Safety Instructions Classification of the Safety Instructions Important information about a possible dangerous situation which, if not avoided, DANGER leads to death or irreversible injuries. - Page 4 WARNING Risk of Falling Due to Permanent Higher Load Do not engage in sport activities with the orthosis that expose it to excessive load. If your patient data has changed (e.g. due to weight gain, growth or increased activity), consult your orthotist or a qualified/trained expert and have them check the suitability of your orthosis with regard to the changed load.
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Page 5: Intended Use
WARNING Risk of Falling Due to Improper Dirt Removal In order to avoid a failure of the lock function, remove dirt from the orthosis and the system joint as described in these instructions for use. Do not grease the system joint on your own. If necessary, consult your orthotist or a qualified/trained expert. -
Page 6: Application
Application All FIOR & GENTZ system joints were developed for everyday life activities such as standing and walking. Extreme impact stress, which occurs for example during long jump, climbing and parachuting, is excluded. The NEURO LOCK Carbon system knee joint is water-resistant and, therefore, it is suited for use in wet areas. The system joint can be used at a maximum temperature of +60°C. -
Page 7: Adjusting The Permanent Unlock Function
Adjusting the Permanent Unlock Function With the permanent unlock function you can disable the system joint's lock function. 1 Press the locking pawl against the joint’s upper part. 2 Hold it in this position. 3 Press the fixing pawl against the joint’s upper part until it snaps into the joint's upper part (fig. -
Page 8: Signs And Symbols
Signs and Symbols CE labelling according to Regulation (EU) 2017/745 for medical devices medical device article number manufacturer batch code follow the instructions for use single patient – multiple uses Unique Device Identifier – product identification number... -
Page 9: Ce Conformity
CE Conformity We declare that our medical devices as well as our accessories for medical devices are in conformity with the requirements of Regulation (EU) 2017/745. Therefore, the FIOR & GENTZ products bear the CE marking. Legal Information With the purchase of this product, our General Terms and Conditions of Business Transactions, Sales, Delivery and Payment will apply. -
Page 10: 10. Handing Over The Orthosis
10. Handing Over the Orthosis When handing over the orthosis to the patient, parents or care team by the orthotist or qualified/trained expert, they also received the instructions for use for patients as well as the orthosis service passport. The functions and handling of the orthosis were explained in detail by means of these instructions for use. - Page 11 ORTHOSIS SERVICE PASSPORT Have you not yet received an orthosis service passport? Ask your orthotist or a qualified/trained expert! Gesellschaft für Entwicklung und Vertrieb Dorette-von-Stern-Straße 5 +49 4131 24445-0 info@fior-gentz.de von orthopädietechnischen Systemen mbH 21337 Lüneburg (Germany) +49 4131 24445-57 www.fior-gentz.com...
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