FIOR & GENTZ NEURO TRONIC Instructions For Use Manual
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FIOR & GENTZ NEURO TRONIC Instructions For Use Manual

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Instructions for Use for Orthotists or
Qualified/Trained Experts
System Knee Joint
2.0
NEURO TRONIC
Download: www.fior-gentz.com
Download: www.fior-gentz.com
EN

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Summary of Contents for FIOR & GENTZ NEURO TRONIC

  • Page 1 Instructions for Use for Orthotists or Qualified/Trained Experts System Knee Joint NEURO TRONIC Download: www.fior-gentz.com Download: www.fior-gentz.com...

  • Page 2: Table Of Contents

    Content Page Instructions for Use for Orthotists or Qualified/Trained Experts System Knee Joint NEURO TRONIC 4 Information Safety Instructions 2.1 Classification of the Safety Instructions 2.2 All Instructions for a Safe Handling of the System Knee Joint 3.1 Intended Use 3.2 Indication...
  • Page 3 17.4 Dirt Removal 18. Period of Use 19. Storage 20. Spare Parts 20.1 Exploded View Drawing NEURO TRONIC 20.2 Spare Parts for the NEURO TRONIC System Knee Joint 20.3 Sliding Washers 21. Disposal 22. Technical Data 22.1 Ambient Conditions 23. Signs and Symbols 24.

  • Page 4: Instructions For Use For Orthotists Or Qualified/Trained Experts System Knee Joint Neuro Tronic

    Instructions for Use for Orthotists or Qualified/Trained Experts System Knee Joint NEURO TRONIC 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.
  • Page 5 WARNING Risk of Falling Due to Improper Processing Process the system joint according to the information in these instructions for use. Deviating processing and modifications of the system joint require the written consent of the manufacturer. WARNING Risk of Falling Due to Improper Processing Always mount the system knee joint to an orthosis with a system ankle joint in order to avoid joint dys- function.
  • Page 6 WARNING Risk of Falling Due to Use of Unauthorised Accessories Use only the accessories specified or supplied by the manufacturer in order to avoid increased electromag- netic emissions and reduced electromagnetic immunity of the knee joint system. WARNING Risk of Falling Due to Electromagnetic Interference Do not use the knee joint system in close proximity to or stacked with other portable RF communication devices in order to avoid impairing the function of the knee joint system.

  • Page 7: Intended Use

    Intended Use The NEURO TRONIC knee joint system with component set, including system knee joint and controller, is ex- clusively for use for orthotic fittings of the lower extremity. The system joint provides stance phase control and is only allowed to be used for producing a KAFO.

  • Page 8: Indication

    Combination Possibilities with Other System Joints The NEURO TRONIC system knee joint must be combined with a system ankle joint from the FIOR & GENTZ product range. The NEURO VARIO system knee joint can be used as a supporting joint.

  • Page 9: Basic Function In Auto Mode

    Terminal swing Initial contact Loading response Mid stance Terminal stance Pre swing Initial swing Mid swing Standfase Terminal sw DE PIE NEURO TRONIC: FASES DE LA MARCHA RELEVANTES PARA LA ARTICULACIÓN STÅENDE...

  • Page 10: Alternative Function In Lock Mode

    3 fig. 4 In Free mode, the NEURO TRONIC system knee joint is unlocked and free moving up to a defined extension position. When the patient is standing with the orthosis, the stance phase control is achieved by means of the integrated posterior offset (fig.

  • Page 11: Neuro Tronic Knee Joint System

    NEURO TRONIC Knee Joint System The knee joint system is equipped with Bluetooth® technology* and consists of the following components (fig. 7): system knee joint controller remote control for the patient including charging cable with adapter and User app Expert app for the orthotist or qualified/trained expert The system knee joint and the controller are built into the patient's orthosis.
  • Page 12 In order to produce a KAFO with the NEURO TRONIC system knee joint, you need a component set which must be purchased as an accessory to the system knee joint. Select the unilateral or bilateral component set depending on the construction. Both sets include only one controller. A second controller is not required for bilateral constructions.

  • Page 13: Scope Of Delivery Of The System Knee Joint

    You can find more information on special work steps that must be observed when building an orthosis with the NEURO TRONIC system knee joint, such as the placement of dummies as well as the specifics of reinforcement, in the corresponding online tutorial (see QR code, fig.

  • Page 14: Mounting The Locking Parts

    Only use the FIOR & GENTZ orthosis joint grease to grease the system components. Mounting the Locking Parts fig. 14 Make sure not to damage the sliding washer during assembly. Jammed sliding washer particles can cause lateral play in the system joint.

  • Page 15: Mounting The Cover Plate

    Mounting the Cover Plate The lever of the cover plate is already premounted. For the following steps, the lever must be set to the symbol. 1 Before the assembly, clean the threads of the bearing nuts with LOCTITE® 7063 Super Clean. Allow the threads to air-dry for 10 minutes. 2 Place the cover plate on the system joint.

  • Page 16: Controller

    Expert app and commands from the remote control/User app, registers the patient’s movements and controls the NEURO TRONIC system knee joint. The controller can be used for a unilateral as well as a bilateral construction. It automatically recognises whether one or two system knee joints are connected to the controller.

  • Page 17: Checking The Orthosis' Basic Alignment

    11. Checking the Orthosis’ Basic Alignment Make sure that the orthosis’ alignment is correct before putting the orthosis into opera- tion. You can then make further adjustments to the orthosis using the Expert app. You can find more information on the correct orthosis’ alignment in the online tutorial Checking the Orthosis’...

  • Page 18: Putting Into Operation

    12. Putting into Operation 12.1 Putting the Expert App into Operation Download the app with your smartphone/tablet. Minimum requirements are Bluetooth 4.0 and Android 6.0 or iOS 10. Unlock the app once from the login area on the FIOR & GENTZ website.

  • Page 19: Adjustment Options With The Expert App

    13. Adjustment Options with the Expert App 13.1 Selecting a Mode You can select the available modes AUTO, FREE and LOCK with the app. The mode is active when the respective mode is displayed with a green background. 13.2 Signal Function for Training Purposes in Auto Mode The signal function for training purposes supports the patient acoustically.

  • Page 20: Result Messages And Further Actions After The Cable Connection Test

    13.3.3.1 Result Messages and Further Actions After the Cable Connection Test The following result messages will be displayed in the app: Result Message Meaning Further Action The cable connection from the control- one system joint connected ler to the system joint is correct. The cable connections from the two system joints connected controllers to both system joints are...

  • Page 21: Mid Stance Settings

    13.3.4.5 Mid Stance Settings With this menu item, you can fine adjust the time when the system knee joint unlocks in mid stance. Follow the instructions in the app. Have the patient practise walking with the orthosis with the adjusted time of unlocking and adapt the settings again, if required.

  • Page 22: Restore To Default Settings

    For patients who have both legs treated with orthoses, we recommend activating the detection of the first step for the orthosis with which the patient wants to take the second step. The first step is therefore taken with the orthosis in a locked state, which provides more stability. For unilateral treatments where the patient feels insecure and takes pathological, slow steps, the detection of the first step should not be activated.

  • Page 23: Conversion Options

    15. Conversion Options The NEURO TRONIC system knee joint can be converted into a NEURO MATIC system knee joint by exchanging individual system components. You can find more information on this in the online tutorial Joint Conversion NEURO TRONIC into NEURO MATIC (see QR code, fig.

  • Page 24: Remote Control

    The system joint cre- The controller is adjusted for a In the Expert app menu, select the ates a ratching noise NEURO HiTRONIC system knee joint. NEURO TRONIC system knee joint. in swing phase. 16.3 Remote Control Problem Further Action The controller does not respond to pressed Check whether the controller is still connected to the buttons on the remote control.

  • Page 25: Maintenance

    17. Maintenance Check the system joint regularly for wear and functionality. In particular, check the joint components listed in the following table for the possible problems described and, if necessary, take the appropriate measures. Also check the functionality after every maintenance carried out. It must be possible to move the system joint without problems or unusual noises.

  • Page 26: Documentation Of Maintenance In The Orthosis Service Passport

    Especially the toothed ring and the locking pawl are subject to greater stress than other system components, which is why you should replace them on a regular basis, regardless of visible signs of wear: Activity Level Point in Time 1 and 2 every 12 months every 9 months every 6 months...

  • Page 27: Checking The Battery Health

    17.2 Checking the Battery Health Regularly check the battery health of the controller with the Expert app. In the case of bad battery health or if the patient needs to charge the controller more than once per day, the controller must be replaced. Do not try to disassemble the controller as the battery is a fixed part of the controller.

  • Page 28: Period Of Use

    18. Period of Use To guarantee a safe use and complete functionality as well as an unlimited period of use of the system joints, you must adhere to the following conditions: - Adhere to the specified maintenance intervals without interruption and document each maintenance (see paragraph 17).

  • Page 29: Spare Parts

    20. Spare Parts 20.1 Exploded View Drawing NEURO TRONIC fig. 41...

  • Page 30: Spare Parts For The Neuro Tronic System Knee Joint

    20.2 Spare Parts for the NEURO TRONIC System Knee Joint Article Number for System Width Item 16mm 20mm Description SB9669-L0990 SB1069-L1000 bearing nut (joint axis) SB6049-L0990 SB8559-L1000 bearing nut (locking pawl) SK0313-L/TI SK0315-L/TI lower part, left lateral or right medial, straight, titanium...

  • Page 31: Sliding Washers

    (fig. 42). Please comply with the applicable national laws and local regulations for the proper recycling of recyclable materials. The electronically controlled, automatic NEURO TRONIC system knee joint also falls under the area of application of the WEEE (Directive 2012/19/EU) of the European Parliament and the Council of 4 July 2012, regarding old electrical and electronic equipment.
  • Page 32 Transport ambient temperature -25°C – +60°C without original packing: max. 95%, non-condensing air humidity relative air humidity with original packing: max. 95% air pressure 1060mbar – 700mbar Storage ambient temperature +5°C – +40°C, no exposure to direct sunlight relative air humidity max.

  • Page 33: Signs And Symbols

    Controller Battery type lithium-polymer battery capacity Auto mode: 36 000 strides with unilateral construction/18 000 strides with operating time at room bilateral construction temperature and full battery Free mode: 24 hours with unilateral construction/12 hours with bilateral charge after 3 years of use construction behaviour of the system knee joint during the charging...
  • Page 34 air humidity limit values for storage/for transportation air pressure limit values for storage/for transportation follow the instructions for use single patient – multiple uses IP44 protection from the ingress of solid foreign bodies (diameter ≥ 1.0mm) and from splashing water on all sides Unique Device Identifier –...

  • Page 35: Ce Conformity

    24. 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. The product satisfies the requirements of the RoHS Directive 2011/65/EU of the European Parliament and of the Council of 8 June 2011, for limiting the use of specific hazardous substances in electrical and electronic equipment.

  • Page 36: Electromagnetic Compatibility

    Usage Instructions and Manufacturer’s Declaration – Electromagnetic Emissions The product NEURO TRONIC is designed for operation in an electromagnetic environment as specified below. The customer or user of the product NEURO TRONIC must ensure that it is operated exclusively in such an environment.

  • Page 37: Electromagnetic Immunity For All Devices And Systems

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

  • Page 38: Electromagnetic Immunity For Non-Life-Supporting Devices And Systems

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

  • Page 39: Recommended Safety Distances Between Portable And Mobile Rf Telecommunication Equipment And The Product Neuro Tronic For Non-Life-Supporting Devices And Systems

    The product NEURO TRONIC is designed for operation in an electromagnetic environment where RF inter- ference is monitored. The customer or user of the product NEURO TRONIC can help prevent electromagnetic interference by complying with the minimum distances between portable and mobile RF communication equipment (transmitters) and the product NEURO TRONIC, as specified below according to the maximum output of the communication equipment.

  • Page 40: Test Specifications For The Immunity Of Enclosures Against Wireless Rf Telecommunication Equipment

    26.6 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 41: Information For The Treatment Documentation

    27. Information for the Treatment Documentation Add these instructions for use to your treatment documentation! Patient Data Name Address Postcode, City Home Telephone Telephone at Work Insurance Insurance No. Attending Physician Diagnosis...

  • Page 42: Handing Over The Orthosis

    28. Handing Over the Orthosis The orthotist or qualified/trained expert has also handed over the instructions for use for patients as well as the orthosis service passport to you as a patient, parent or care team. By means of these instructions for use, the functions and handling of the orthosis were explained to you in detail.

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