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

System knee joint
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Instructions for Use for Qualified Specialists
in Orthopaedic Technology
System Knee Joint
NEURO HiTRONIC
NEURO HiTRONIC
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Summary of Contents for FIOR & GENTZ NEURO HiTRONIC

  • Page 1 Instructions for Use for Qualified Specialists in Orthopaedic Technology System Knee Joint NEURO HiTRONIC NEURO HiTRONIC Download: www.fior-gentz.com Download: www.fior-gentz.com...

  • Page 2: Table Of Contents

    Alternative Function in Lock Mode Alternative Function in Free Mode Alternative Function in Permanent Unlocking Rotary Switch NEURO HiTRONIC Knee Joint System Scope of Delivery of the System Knee Joint Load Tools for Assembling the System Joint 10. Functional Unit 11.
  • Page 3 28.5 Electromagnetic Immunity to Proximity Magnetic Fields 28.6 Recommended Safety Distances between Portable and Mobile RF Telecommunication Equipment and the Product NEURO HiTRONIC for Non-Life-Supporting Devices and Systems 28.7 Test Specifications for the Immunity of Enclosures Against Wireless RF Telecommunication Equipment 28.8...

  • Page 4: Instructions For Use For Qualified Specialists In Orthopaedic Technology System Knee Joint Neuro Hitronic

    Instructions for Use for Qualified Specialists in Orthopaedic Technology System Knee Joint NEU- RO HiTRONIC Information These instructions for use are addressed to qualified specialists in orthopaedic technology 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 Permanent Higher Load If patient data has changed (e.g. due to weight gain, growth or increased activity), recalculate the ex pected load on the system joint, plan the treatment again and, if necessary, produce a new orthosis. 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-...
  • Page 6 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. If such use is necessary, observe the knee joint system and other portable RF communication devices in use to ensure that they function normally.
  • Page 7 WARNING Risk of Injury Due to Improper Handling of the System Joint When using the system joint, an opening is formed between the joint’s upper and lower part, in which clothing or skin could get caught. Please inform the patient of this risk. NOTICE Limitation of the Joint Function Due to Improper Processing Errors in processing can impair the joint function.

  • Page 8: Use

    Combination Possibilities with Other System Joints The NEURO HiTRONIC 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: Joint Functions

    Safe Handling of the Joint Functions Standing Up From a Seated Position Before the patient stands up, the NEURO HiTRONIC system knee joint must be set to Free mode. Once standing securely, the mode can be switched to Auto or Lock mode.

  • Page 10: Alternative Function In Lock Mode

    Alternative Function in Free Mode In Free mode, the NEURO HiTRONIC 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: Alternative Function In Permanent Unlocking

    Alternative Function in Permanent Unlocking The NEURO HiTRONIC system knee joint can be permanently unlocked mechanically with a rotary switch, for example for activities such as riding a bicycle. In this mode it is guaranteed that the system knee joint does not lock unintentionally.

  • Page 12: Neuro Hitronic Knee Joint System

    NEURO HiTRONIC Knee Joint System The knee joint system is equipped with Bluetooth® technology* and consists of the following components (fig. 5): system knee joint controller remote control for the patient including charging cable with adapter and User app Expert app for qualified specialists in orthopaedic technology The system knee joint and the controller are built into the patient's orthosis.
  • Page 13 For the production of a KAFO with the NEURO HiTRONIC you need, in addition to the system knee joint, a component set consisting of a controller set and a remote control set, a maintenance set as well as a tool set. The lamination dummy for the controller included in the tool set is reusable.
  • Page 14 Remote Control Set (SK3850-P) Quantity Item Article Number Description Unit Unilateral ET3840-P remote control pce. ET0780 adapter pce. ET0710-01 charging cable for controller, 1m pce. lanyard FIOR & GENTZ PR4000 pce. HE3800-SK/L letter sticker L for remote control, left leg pce.
  • Page 15 For the production of a KAFO with the NEURO HiTRONIC in combination with the NEURO HiSWING R+ system ankle joint you need a controller set, a remote control set, a con- nection cable set, a maintenance set as well as a tool set. The lamination dummy for the controller included in the tool set is reusable.

  • Page 16: Scope Of Delivery Of The System Knee Joint

    You can find more information on special work steps that must be observed when pro- ducing an orthosis with the NEURO HiTRONIC system knee joint, such as the placement of dummies as well as the specifics of reinforcement, in the corresponding online tutorial fig.

  • Page 17: Load

    Secure all screws with the torque specified in paragraph 11.6. You can find more information on the assembly in the online tutorial Joint Assembly NEURO HiTRONIC (see QR code, fig. 15) on the FIOR & GENTZ website. The hydraulic system of the functional unit must not be opened.

  • Page 18: Preparation Of The Joint's Upper Part

    When mounting the system joint, mind the correct basic alignment of the orthosis as it is essential for the later function of the orthosis. You can find more information on this in the online tutorial KAFO Alignment Guidelines (see QR code, fig.

  • Page 19: Mounting The System Joint

    11.4 Mounting the System Joint Make sure not to damage the sliding washer during assem- bly. Jammed sliding washer particles can cause lateral play in the system joint. fig. 22 1 Grease the axle bore and the sliding surfaces of the bearing nut with a drop of orthosis joint grease (fig.

  • Page 20: Securing The Screws

    Tutorials” on the FIOR & GENTZ website. 13. Conversion Options An orthosis with a NEURO HiTRONIC system knee joint can be converted into an orthosis with a NEURO TRONIC or NEURO MATIC system knee joint by exchanging the system fig. 31...

  • Page 21: Controller

    14. Controller The controller is mounted to the orthosis. It receives adjustments from the Expert app and commands from the remote control/User app, registers the patient’s movements and controls the NEURO HiTRONIC system knee joint. When producing the orthosis, ensure that the controller is positioned so that the charging port is at the bottom.

  • Page 22: Cable Connection For The Controller And Functional Unit

    14.1 Cable Connection for the Controller and Functional Unit Only tighten the knurled threaded bushings by hand. Do not use pliers to tighten the threaded bushings. fig. 32 Before you mount the controller onto the orthosis, you must estab- lish a connection to the functional unit of the system knee joint via a connection cable.

  • Page 23: Checking The Orthosis' Basic Alignment

    15. 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 tutorials Checking the Orthosis’...

  • Page 24: Connection Between Controller And Remote Control

    16.2 Connection between Controller and Remote Control In order to connect the remote control to the controller, proceed as follows: 1 Press the MODE button on the controller. First, a short beep is emitted. Press and hold the button until a second, longer beep is emitted after about 6–10 seconds.

  • Page 25: Main Menu

    17.3 Main Menu In the main menu you can set various adjustments for the orthosis. Follow the instructions in the app. 17.3.1 Pairing (Putting the Controller Into Operation) In order to establish a connection between the controller and the app, use the app’s menu and select the re- quired menu item for a connection with one or two controller(s).

  • Page 26: Sound

    17.3.4.2 Sound In the sound settings, you can set the volume, tone and type of signal tone for the signal function for patient training purposes (see paragraph 17.2). Follow the instructions in the app. With the tone, you can choose between two frequencies. This way, you can select a different tone for each controller/orthosis at a bilateral treatment.

  • Page 27: First Step

    17.3.4.7 First Step With this menu item you can adjust the settings for the first step to facilitate walking. In the default setting, the detection of the first step is deactivated. This is the safest setting as the orthosis only unlocks in the second swing phase.

  • Page 28: Advice On Optimal Orthosis Functionality

    The controller is adjusted for a In the Expert app menu, select the NEURO TRONIC system knee joint. NEURO HiTRONIC system knee joint. With the Expert app, change the settings for unlocking in mid stance. The earlier the point in time is chosen, the easier the The patient has an abnormal gait.

  • Page 29: Remote Control

    Problem Cause Measure The battery was not charged. Charge the battery. The system joint switches uninten- tionally into Lock Due to shocks, the magnetic field is mode. The orthosis undergoes strong shocks interrupted and the orthosis locks auto- when it is set to Free or Auto mode. matically.
  • Page 30 Recommended Inspection, Potential Latest Joint Component Potential Problem Measure Replacement* Replacement roll unit** wear replacing roll unit every 6 months every 6 months air filter** soiling replacing air filter every 6 months every 6 months guide piece wear replacing guide piece every 6 months every 6 months flexion stop disc every 12...

  • Page 31: Documentation Of Maintenance In The Orthosis Service Passport

    Secure the screws for the cover plate with the appropriate torque and LOCTITE® 243 medium strength during every maintenance (see paragraph 11.6). Remove all adhesive residues first. You can find the individual maintenance plans for system joints in the download area (see QR code, fig.

  • Page 32: Replacing The Roll Unit

    19.5 Replacing the Roll Unit 1 Demount the functional unit from the system joint. 2 Keep the plunger in place by gripping it from the slot with a 6.5mm double open-end wrench, and loosen the roll unit with a 13mm socket wrench insert with adapter (fig.

  • Page 33: Spare Parts

    22. Spare Parts 22.1 Exploded View Drawing NEURO HiTRONIC fig. 43 The functional unit is delivered preassembled. If individual components of the functional unit (fig. 44) have to be exchanged, you can order them as well. fig. 44...

  • Page 34: Spare Parts For The Neuro Hitronic System Knee Joint

    22.2 Spare Parts for the NEURO HiTRONIC System Knee Joint Article Number for System Width Item 20mm Description SB1069-L1110 bearing nut SL0315-L/TI lower part, left lateral, straight, titanium SL0315-R/TI lower part, right lateral, straight, titanium GS2411-* sliding washer* SL9005-E005 5° extension stop...

  • Page 35: Disposal

    The electronically controlled, automatic NEURO HiTRONIC 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 36: Technical Data

    24. Technical Data NEURO HiTRONIC period of use unlimited, excluding wear parts (see paragraph 19) protection type IP44 operating mode continuous operation 24.1 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 37 Adapter with Charging Cable (not Part of the Medical Device) Controller ET3850 Controller ET3860 article number ET0780 ET0780-01 manufacturer’s designation HNP12-USBV2, HNP07-USBV2 FW8002.1MUSB/05 ambient temperature in -10°C – +40°C 0°C – +45°C operation ambient temperature in -20°C – +70°C -40°C – +70°C storage relative air humidity 10% –...

  • Page 38: Signs And Symbols

    25. Signs and Symbols CE labelling according to Regulation (EU) 2017/745 for medical devices medical device article number Do not dispose of electronic devices with household waste. Dispose of the device and accessories at official delivery points for electronic devices. manufacturer batch code serial number...
  • Page 39 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 – product identification number Remote Control Type Plate ET3840-P IP44 FIOR & GENTZ GmbH ET3840-P IP44 www.fior-gentz.de FIOR &...

  • Page 40: Ce Conformity

    26. 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 41: Electromagnetic Compatibility

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

  • Page 42: Electromagnetic Immunity For All Devices And Systems

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

  • Page 43: Electromagnetic Immunity For Non-Life-Supporting Devices And Systems

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

  • Page 44: Electromagnetic Immunity To Proximity Magnetic Fields

    Frequency Range of 9kHz to 13.56MHz The product NEURO HiTRONIC is designed for operation in an electromagnetic environment as specified below. The customer or user of the product NEURO HiTRONIC must ensure that it is operated exclusively in such an environment.

  • Page 45: Test Specifications For The Immunity Of Enclosures Against Wireless Rf Telecommunication Equipment

    28.7 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 modulation 380 to 390 TETRA 400 18Hz GMRS 460, 430 to 470 ±...

  • Page 46: Usa: Fcc Regulatory Compliance Statement

    28.8 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 47: Information For The Treatment Documentation

    29. 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 48: Handing Over The Orthosis

    30. Handing Over the Orthosis The qualified specialist in orthopaedic technology 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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