Nabtesco Symphony NK-6 Instruction Manual

Nabtesco Symphony NK-6 Instruction Manual

Manual for prosthetist, 6-bar hydralic knee
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NK6 Symphony Knee
Distributeur
Instruction Manual -
for Prosthetist

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Summary of Contents for Nabtesco Symphony NK-6

  • Page 1 NK6 Symphony Knee Distributeur Instruction Manual - for Prosthetist...
  • Page 3 NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Introduction Thank you for using the NK-6 Symphony. This product is a prosthetic knee joint which ensures high stability of stance and excellent ability to response to the walking speed through unique 6-bar linkage system and hydraulic cylinder. Before using the product, read this Instruction Manual, and understand the correct procedures for using.
  • Page 4 Doing so can cause injury or damage NK-6 Symphony. WARNING Cautions for handling NK-6 Symphony safely Nabtesco Corporation (hereinafter, referred to as Nabtesco) cannot foresee all of potential residual risks of NK-6 Symphony and risks resulting from human errors and usage environment.
  • Page 5 NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Important Information If you have a serious incident related to NK-6 Symphony, please report it to the manufacturer (contact information on the back cover) and the competent authority in your country.
  • Page 6 It covers the following references: NK-6, NK-6SH, NK-6+L and KN-6SH+L. Copy right Nabtesco owns the copyright for this document. It is not permitted to duplicate any part of drawings and technical documents including this document by any means (copying or recording on electronic media) without our prior authorization.
  • Page 7: Table Of Contents

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Contents Safety Precautions ..............................................Contraindications ......................Definition of Symbols ....................... Mandatory Precautions ..........Compatible medical devices (prosthesis components) Basic Construction and Operational Principle ................................... Basic Construction ......................Operational Principle ......................
  • Page 8: Safety Precautions

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Safety Precautions 1.1 Contraindications Person who cannot understand how to use the knee and caution for use  Person who has problem and pain on the residual limb  Person who weighs over 125kg (if high-active user: over 100kg) ...
  • Page 9: Mandatory Precautions

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Safety Precautions 1.3 Mandatory Precautions WARNING This product shall Hand the separate be used as a User’s Guide to the prosthetic knee user and explain the joint. Never use it instructions for use.
  • Page 10 NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Safety Precautions DO NOT place the hand behind the knee when flexing DO NOT use for a the knee. person who weighs DO NOT touch the over 125 kg. knee when...
  • Page 11 NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Safety Precautions CAUTION Make adjustments in accordance with DO NOT drop parts the adjustment such as a screw in procedures the frame. stated in the MANDATORY PROHIBITION Instruction Manual. ACTION Continued use after any part is...
  • Page 12: Compatible Medical Devices (Prosthesis Components)

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Safety Precautions 1.4 Compatible medical devices (prosthesis components) Symphony Reference NK-6 / NK-6+L NK-6SH / NK-6SH+L Female M36 screw Proximal connectors pyramidal connectors connectors Female Female Distal connectors pyramidal pyramidal connectors...
  • Page 13: Basic Construction And Operational Principle

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Basic Construction and Operational Principle 2.1 Basic Construction The NK-6 Symphony consists of a 6-bar linkage which controls the stance phase and a hydraulic cylinder which controls the swing phase. The selective lock with which the user can lock the knee by himself/herself can be chosen at the user’s option.
  • Page 14: Stance Phase Control

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Basic Construction and Operational Principle 2.3 Stance Phase Control p-MRS system (Polycentric-Mechanism of Stance- Flexion Stiffness Sensing) The 6-bar linkage detects the floor reaction force position and controls the stance phase. The center of rotation of this linkage system, the sensing point is located around the toe break.
  • Page 15: Swing Phase Control

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Basic Construction and Operational Principle 2.4 Swing Phase Control A hydraulic cylinder is used for swing phase control. The swing phase is controlled based on the hydraulic resistance generated when the knee is flexed and extended.
  • Page 16: Before Use

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Before Use 3.1 Scope of Delivery Please confirm that the following items are included: NK-6 Symphony  User’s Guide  (After explaining the instructions for use, hand it to the user) Instruction Manual (this document) ...
  • Page 17: Contact Of Socket At The Maximum Flexion Angle

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Before Use 3.2.2 Contact of socket at the maximum flexion angle Make the socket in such a way that the socket or the buttock is in contact with the foot part when the knee joint is flexed at the maximum flexion angle.
  • Page 18: Adjusting The Stance Phase Control

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Adjustment 4.1 Adjusting the Stance Phase Control 4.1.1 Adjusting the stance-flexion rubber For adjustment of the stance phase control, adjust the stiffness of the stance-flexion rubber. Adjust the adjusting screw shown in Fig. 9 with a 3 mm hexagonal wrench.
  • Page 19: Adjusting The Extension Assist Spring

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Adjustment 4.1.2 Adjusting the extension assist spring The extension assist spring keeps the knee joint in the full extension when the prosthesis is lifted from the floor. Adjust the adjusting bolt shown in Fig. 10 with a 2.5 mm hexagonal wrench.
  • Page 20: Adjusting The Swing Phase Control

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Adjustment 4.2 Adjusting the Swing Phase Control To adjust the swing phase control, select appropriate flexion and extension resistances using the two adjusting valves of the hydraulic cylinder. 4.2.1 Adjusting the flexion resistance of hydraulic cylinder At first, adjust the flexion resistance.
  • Page 21 NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Adjustment Front link Hydraulic cylinder Flexion adjusting valve (F) Fig. 11 - Location of the Flexion Adjusting Valve Max. resistance Reference Min. resistance mark Fig. 12 - Graduated Scale of the Flexion Adjusting Valve...
  • Page 22 NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Adjustment Extension adjusting valve (E) Fig. 13 - Location of the Extension Adjusting Valve Reference Max. resistance Min. resistance mark Fig. 14 - Graduated Scale of the Extension Adjusting Valve NK6 Symphony Knee Instruction Manual - For Prosthetists...
  • Page 23: Operation Procedures And Precautions

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Operation Procedures and Precautions 5.1 How to Activate the “Stance-Flexion” Function Fig. 15 shows how to apply the body weight to the prosthesis. When the weight is placed on the heel as shown in the left figure while the knee is fully extended, the knee is automatically locked (self-locked) and slightly flexed (stance-flexion).
  • Page 24: Procedures For Operating The Selective Lock

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Operation Procedures and Precautions 5.2 Procedures for Operating the Selective Lock The selective lock is to be operated by the user. The user shall thoroughly understand the operating procedures. The selective lock mechanism has a switch above the knee joint to switch the lock mode on or off.
  • Page 25: Precautions For Operating The Selective Lock

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Operation Procedures and Precautions 5.3 Precautions for Operating the Selective Lock [ Precautions for locking operation ] Instruct the user to make sure that the selective lock is securely activated before starting to walk.
  • Page 26: Precautions When Sitting In And Standing Up From A Chair

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Operation Procedures and Precautions 5.4 Precautions When Sitting in and Standing up from a Chair When sitting in a chair, never place the hand behind the knee. The hand  can be caught in the swaying part of the hydraulic cylinder, causing serious injury.
  • Page 27: Troubleshooting

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Troubleshooting Items to be Status Countermeasures checked The self-lock cannot be Check if body weight is applied Teach the user how to fully activated even if the properly. apply body weight to the stanceflexion rubber is heel.
  • Page 28 NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Troubleshooting Items to be Status Countermeasures checked Abnormal noise or Check if a foreign object is Remove it. rattling occurred. caught in the moving part. Check if any parts are missing.
  • Page 29: Maintenance

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Maintenance The maintenance of the device must be carried out at least every 2 years. 7.1 Replacing the Extension Stopper Rubber Replace the extension stopper rubber when terminal impact occurs in the swing phase (if the impact cannot be eliminated by adjusting the valve (E) on the extension side of the hydraulic cylinder).
  • Page 30: Replacing The Stance-Flexion Rubber

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Maintenance 7.2 Replacing the Stance-Flexion Rubber If looseness or abnormal noise occurs when the self-lock is activated, replace the stance-flexion rubber The stance-flexion rubber is an expendable. The rubber may deteriorate earlier under some use conditions.
  • Page 31: Removing The Base Bracket Cover

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Maintenance 7.3 Removing the Base Bracket Cover Remove the Base bracket cover by following procedures when replacing the extension stopper rubbers or the stance-flexion rubber as described in 7-1 or 7-2.
  • Page 32: Outline Of The Product

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Outline of the Product Specifications Model No. NK-6 NK-6+L NK-6SH NK-6SH+L Proximal Male Pyramid Adapter Screw Head Connection Selective Lock Total Length 197 mm 191 mm 14 mm 14.5 mm ref. measurement...
  • Page 33 NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Outline of the Product Fig. 23 - Installation Height Lifetime: 6 years  Features Smooth walking The product is named “Symphony” because the knee smoothly harmonizes between the stance phase and swing phase control. The p-MRS system controls shifting from the stance phase to the swing phase seamlessly.
  • Page 34: Disposal

    The table below shows the materials of the NK-6 Symphony knee unit in each component. When disposing of the knee joint, comply with the rules stipulated in the local community. If you return it to Nabtesco after giving such a notification, they will dispose it for you. Classification...
  • Page 35 NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Disposal Alignment block Lever Knee plate Knee cover Front link Verbinding vooraan Hydraulic cylinder Front link cover Base bracket cover Base link Supplementary link 10. Spring 11. Stance-flexion rubber 12. Alignment block...
  • Page 36: Symbols Used On Labels

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Symbols Used on Labels 10.1 UDI Label (Packing Box) Symbol Definition Legal manufacturer Medical device Serial number Made date Item number Global Trade Item Number Authorized representative for EU countries The maximum and minimum temperatures for storing, transporting, and using the product.
  • Page 37: Body Mass Limit Label (Knee Joint Body)

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Symbols Used on Labels 10.2 Body Mass Limit Label (Knee Joint Body) Body mass limit not to be exceeded. K Level (MOB) K1 Level (MOB1): User can move to a bed or chair, and can walk on a flat ...
  • Page 38 Document Number: 81-SS00084E (Ver. 2) Data of issue: July 1, 2021 Manufacture Authorized representative for EU countries Nabtesco Corporation PROTEOR SAS Accessibility Innovations Company 6 rue de la Redoute Assistive Products Department 21850 Saint-Apollinaire 35, Uozakihama-machi Higashinada-ku France Kobe, Japan 658-0024...

This manual is also suitable for:

Symphony nk-6+lSymphony nk-6shSymphony nk-6sh-l

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