Nabtesco Symphony NK6 User Manual

Nabtesco Symphony NK6 User Manual

6-bar hydraulic knee
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NK6 Symphony Knee
Distributeur
User's Guide -
for Users

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Summary of Contents for Nabtesco Symphony NK6

  • Page 1 NK6 Symphony Knee Distributeur User’s Guide - for Users...
  • 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 respond to the walking speed through unique 6-bar linkage system and hydraulic cylinder. Before using the product, read this User’s Guide, 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 Basic Construction and Operational Principle ................................... Basic Construction ......................Operational Principle Before Use ......................................How to Activate the “Stance-Flexion” Function ........
  • 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  Instructions for storage  DO NOT put the DO NOT put product in a high anything on the place. DO NOT place product. DO NOT it against something step on it.
  • Page 12 NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Safety Precautions  Instructions for use  Do not use the Do not use the product where product near open the outdoor flame or where temperature is the temperature lower than –20°C.
  • 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: Before Use

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Before Use 3.1 How to Activate the “Stance-Flexion” Function Fig. 3 shows how to load the prosthesis equipped with this knee joint. When the weight is placed on the heel as shown in the left figure while the knee is completely extended, the knee is automatically locked (self-locked) and slightly flexed (stanceflexion).
  • Page 15: Procedures For Operating The Selective Lock (Optional Function)

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Before Use 3.2 Procedures for Operating the Selective Lock (Optional Function) 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 16: Precautions For Operating The Selective Lock

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Before Use 3.3 Precautions for Operating the Selective Lock [ Precautions for locking operation ] Before starting to walk, make sure that the selective lock is securely activated. CAUTION VOORZICHTIG To operate the selective lock, slide the switch surely to the position shown in Fig.
  • Page 17: Precautions When Sitting In And Standing Up From A Chair

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Before Use 3.4 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 18 NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Before Use 3.5 Wiping Off Dirt on the Surface If necessary, wipe the surface with a soft cloth moistened with fresh water. Make sure that no moisture or lint from the cloth remains after wiping. Rust and lint caught in the knee may cause abnormalities in the rotating part and affect the bending and stretching of the knee.
  • Page 19: 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 Practice how to fully apply activated. properly. body weight to the heel. Check for proper alignment.
  • Page 20: 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 21 NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Outline of the Product Fig. 7 - 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 22: 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, we will dispose of it for you.
  • Page 23 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 24: Symbols Used

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Symbols Used 7.1 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 25: Body Mass Limit Label (Knee Joint Body)

    NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V. Symbols Used 7.2 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 26 Document Number: 81-SS00085E (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...

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