FIOR & GENTZ NEURO HiSWING R+ Instructions For Use For Patients
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FIOR & GENTZ NEURO HiSWING R+ Instructions For Use For Patients

System ankle joint
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Instructions for Use for Patients
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System Ankle Joint NEURO HiSWING R+

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Summary of Contents for FIOR & GENTZ NEURO HiSWING R+

  • Page 1 Instructions for Use for Patients System Ankle Joint NEURO HiSWING R+...

  • Page 2: Table Of Contents

    Instructions for Use for Patients Content Page NEURO HiSWING R+ System Ankle Joint  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 Ankle Joint System 3.1 Joint Functions 3.2 Modes 3.2.1 Zero Mode...
  • Page 3 10. Maintenance 10.1 Dirt Removal 11. Storage 12. Advice on Optimal Orthosis Functionality 12.1 System Ankle Joint 12.2 Controller 13. Disposal 14. Technical Data 14.1 Ambient Conditions 15. Signs and Symbols 16. CE Conformity 17. Legal Information 18. Electromagnetic Compatibility 18.1 Electromagnetic Environment 18.2 Electromagnetic Emissions for all Devices and Systems 18.3 Electromagnetic Immunity for all Devices and Systems...

  • Page 4: Instructions For Use For Patients System Ankle Joint Neuro Hiswing R

    Instructions for Use for Patients System Ankle Joint NEURO HiSWING R+ Dear Patient, You have received an individually produced orthosis with a high quality FIOR & GENTZ electrohydraulic system ankle joint from a qualified specialist in orthopaedic technology. 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 5 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 a qualified specialist in orthopaedic technology and have them check the suitability of your orthosis with regard to the changed load.
  • Page 6 WARNING Risk of Falling Due to Changes in the Orthosis If you notice any changes in the orthosis (e.g. loosely attached joint components, loosened screws, play in the system joint or change in performance), immediately contact a qualified specialist in orthopaedic technology.
  • Page 7 WARNING Risk of Injury Due to Improper Handling of the Controller Use the controller as described in these instructions for use. The orthosis may not be worn while it is charging. The controller is a sensitive electronic device with an integrated lithium-polymer battery. When handling the controller please avoid: - strong heat (e.g.

  • Page 8: Use

    Intended Use The FIOR & GENTZ automatic electronic system ankle joint is exclusively for use for orthotic fittings of the lower extremity. The system joint is only allowed to be used for producing an AFO or a KAFO. Every system joint influences the orthosis’...

  • Page 9: Ankle Joint System

    Ankle Joint System The ankle joint system is equipped with Bluetooth® technology* and consists of the following components (fig. 2): system ankle joint controller charging cable with adapter and User app for the patient Expert app for qualified specialists in orthopaedic technology The system ankle joint and the controller are built into your orthosis.

  • Page 10: Joint Functions

    You have received the following system components in addition to your orthosis (fig. 3): Item Art. No. Description Unit Quantity ET0710-01 charging cable piece ET0780-01 adapter piece fig. 3 Joint Functions The NEURO HiSWING R+ is a microprocessor-controlled, automatic system ankle joint and provides the following joint functions: - Zero mode for resetting the lower leg-to-plumb line angle to the basic position, e.g.

  • Page 11: Zero Mode

    If the orthosis is exposed to strong shocks, vibrations or fluctuations in air pressure, a safety mech- anism is activated. Angle adjustment is not possible at this point. Press the control button on the system joint once (fig. 7) so that the orthosis can be used normally again. For safety reasons, it is not possible to change the lower leg-to- plumb line angle of the orthosis when one of the spring units is loaded.

  • Page 12: Relax Mode

    3.2.2 Relax Mode In Relax mode, the system ankle joint is free moving and you can freely ad- just the lower leg-to-plumb line angle to relax the foot while sitting (fig. 6) or to put on or take off the orthosis. If the automatic system ankle joint has been combined with an automatic system knee joint, Relax mode is not available.

  • Page 13: Pairing

    3.3.1 Pairing In this menu item of the User app, you can establish a connection between the controller of your orthosis and the User app. To do so, follow the instructions in the app. 3.3.2 Step Counter The app gives you access to the step counter, which counts all steps you take with the leg with orthosis. If you would like to know how many steps you have taken in total (with both legs), double the value.

  • Page 14: Manual Mode Change

    Manual Mode Change A MODE button is built into the controller, which can be used to change the mode of the orthosis without the app. Depending on the mode that is already selected, it can be switched in the following order by pressing briefly: Zero, Relax and standby.

  • Page 15: Checking The Mode And Battery Status

    Checking the Mode and Battery Status Indication of Mode and Battery Status on the Controller You can see the mode and battery status of the controller in the app. Furthermore, the LED battery level indi- cator displays the following light signals for the battery status: Light Signal Meaning colour: yellow, green, red (depending on battery status)

  • Page 16: Energy-Saving Modes

    Energy-Saving Modes Your orthosis has three different energy-saving modes: - If the orthosis is not moved in Zero, Relax or Stair mode for more than two hours, the orthosis switches into standby automatically. Energy is saved in standby. - If the orthosis is not moved for more than 30 minutes in standby, it will automatically switch into Sleep mode.

  • Page 17: Advice On Using Your Orthosis

    Advice on Using Your Orthosis Bluetooth Connection The connection quality depends on how interference-free your environment is. Malfunction Due to External Impact If possible, avoid causing serious damage to your orthosis, e.g. through shocks, impacts or falls, as these can lead to impairment of individual system components and, in the worst case, to failure of the orthosis.

  • Page 18: Dirt Removal

    10.1 Dirt Removal Remove dirt from the system joint on a regular basis. Use a dry cloth and clean the system joint only super- ficially. Then, remove visible dust and lint from the mechanics by using tweezers. Check the orthosis in straight and flexed position.

  • Page 19: Technical Data

    14. Technical Data NEURO HiSWING R+ period of use unlimited, excluding wear parts protection type IP44 operating mode continuous operation 14.1 Ambient Conditions Operation -10°C – +40°C ambient temperature +5°C – +40°C when charging the battery, no exposure to direct sunlight relative air humidity 0% –...

  • Page 20: Signs And Symbols

    Adapter with Charging Cable (not Part of the Medical Device) article number ET0780-01 manufacturer’s designation FW8002.1MUSB/05 ambient temperature in 0°C – +45°C operation ambient temperature in -40°C – +70°C storage relative air humidity 10% – 90%rH input voltage 100V – 240V input frequency 50Hz –...
  • Page 21 manufacturer batch code serial number protect from heat keep dry temperature limit values for storage/for transportation air humidity limit values for storage/for transportation air pressure limit values for storage/for transportation follow the instructions for use (white on blue background) single patient – multiple uses IP44 protection from the ingress of solid foreign bodies (diameter ≥...

  • Page 22: Ce Conformity

    Controller Type Plate Input: 5V/1A, Type: FW8002.1MUSB/05 Made in Germany FIOR & GENTZ Dorette-von-Stern-Straße 5 D-21337 Lüneburg ET3860 ABCDEF-UVXYZ IP44 16. 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.

  • Page 23: Electromagnetic Compatibility

    18. Electromagnetic Compatibility Special precautions must be taken for all electronic medical devices as regards electromagnetic compatibility (EMC). This device complies with standard IEC 60601-1-2:2022-01. - All electronic medical devices must be installed and put into operation in compliance with the EMC- relevant information contained in these instructions for use.

  • Page 24: Electromagnetic Immunity For All Devices And Systems

    18.3 Electromagnetic Immunity for all Devices and Systems Usage Instructions and Manufacturer’s Declaration – Electromagnetic Immunity The product NEURO HiSWING R+ is designed for operation in an electromagnetic environment as specified below. The customer or user of the product NEURO HiSWING R+ must ensure that it is operated exclusively in such an environment.

  • Page 25: Electromagnetic Immunity For Non-Life-Supporting Devices And Systems

    18.4 Electromagnetic Immunity for Non-Life-Supporting Devices and Systems Usage Instructions and Manufacturer’s Declaration – Electromagnetic Immunity The product NEURO HiSWING R+ is designed for operation in an electromagnetic environment as specified below. The customer or user of the product NEURO HiSWING R+ must ensure that it is operated exclusively in such an environment.

  • Page 26: Recommended Safety Distances Between Portable And Mobile Rf Telecommunication Equipment And The Product Neuro Hiswing R+ For Non-Life-Supporting Devices And Systems

    18.5 Recommended Safety Distances between Portable and Mobile RF Telecommunication Equipment and the Product NEURO HiSWING R+ for Non-Life-Supporting Devices and Systems Usage Instructions and Manufacturer’s Declaration – Recommended Safety Distances between Portable and Mobile RF Telecommunication Equipment and the Product NEURO HiSWING R+ The product NEURO HiSWING R+ is designed for operation in an electromagnetic environment where RF interference is monitored.

  • Page 27: Test Specifications For The Immunity Of Enclosures Against Wireless Rf Telecommunication Equipment

    18.6 Test Specifications for the Immunity of Enclosures Against Wireless RF Telecommunication Equipment Test Frequency Maximum Distance Immunity Test Frequency Band Radio Service Modulation Output Level [V/m] [MHz] [Mhz] pulse modula- 380 to 390 TETRA 400 tion 18Hz GMRS 460, 430 to 470 ±...

  • Page 28: Usa: Fcc Regulatory Compliance Statement

    18.7 USA: FCC Regulatory Compliance Statement This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

  • Page 29: Handing Over The Orthosis

    19. Handing Over the Orthosis When handing over the orthosis to the patient, parents or care team by the qualified specialist in orthopaedic technology, 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 30 ORTHOSIS SERVICE PASSPORT Have you not yet received an orthosis service passport? Ask a qualified specialist in orthopaedic technology! 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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