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Nabtesco Symphony NK-6 Instruction Manual

6-bar hydraulic knee joint
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For Prosthetists
6-Bar Hydraulic Knee Joint
NK-6 Symphony
Instruction Manual
6
-Bar Hydraulic Knee NK-6
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. Keep it
handy for future reference. Hand the
separate User's Guide to the user, and
explain the instructions for use.

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Summary of Contents for Nabtesco Symphony NK-6

  • Page 1 For Prosthetists 6-Bar Hydraulic Knee Joint NK-6 Symphony Instruction Manual -Bar Hydraulic Knee NK-6 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.
  • Page 3 NK-6 Symphony. ■ 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. Although there are a lot of instructions and...
  • Page 4 This document is intended for the prosthetists to fit the product for prosthetic users. It covers the following references: NK-6, NK- 6SH, NK-6+L and KN-6SH+L. ■ Copy right Nabtesco owns copyright this document. It is not permitted to duplicate any...

  • Page 5: Table Of Contents

    Contents 1. Safety Precautions ............P.4 1-1 Contraindications ............ P.4 1-2 Definition of Symbols ..........P.4 1-3 Mandatory Precautions ..........P.5 1-4 Compatible medical devices (prosthesis components) ................P.5 2. Basic Construction and Operational Principle ....P.9 2-1 Basic Construction ..........P.9 2-2 Operational Principle ..........

  • Page 6: Safety Precautions

    1. 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) Use for any sports which give high impact on the knee 1-2 Definition of Symbols Indicates a potentially...

  • Page 7: Mandatory Precautions

    1-3 Mandatory Precautions WARNING Hand the separate User’s Guide to the user MANDATORY and explain the ACTION instructions for use. Improper use can cause a fall or injury. Upon detecting any abnormal noise, play, or drop in hydraulic resistance, discontinue MANDATORY ACTION use and contact your...
  • Page 8 DO NOT use for a person who weighs over 125 kg. PROHIBITION NK-6 Symphony was tested for 3 million walking cycles with load of 125kg which corresponds to the average working distance within about 3 years. We will not assume liability for ageing or damage of the product.
  • Page 9 CAUTION Make adjustments in accordance with the adjustment procedures MANDATORY stated in the Instruction ACTION Manual. Improper adjustments may result in poor performance. When making a socket, ensure that the socket or the buttock is in contact with the foot MANDATORY ACTION part at the maximum...

  • Page 10: Compatible Medical Devices (Prosthesis Components)

    Do not store the product where the temperature may exceed the range of PROHIBITION -20 to 50°C. Parts may be deteriorated or deformed, thereby causing failure. 1-4 Compatible medical devices (prosthesis components) Symphony NK-6 NK-6SH reference NK-6+L KN-6SH+L Female Proximal M36 screw pyramidal connectors...

  • Page 11: Basic Construction And Operational Principle

    2. 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 12: Stance Phase Control

    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 13: Swing Phase Control

    2-4 Swing Phase Control A hydraulic cylinder is used for swing phase control. swing phase controlled based hydraulic resistance generated when the knee is flexed and extended. The resistance at the initial swing phase is kept at a low level so that the user can initiate the swing phase easily, and the resistance is increased when the flexion angle is 40°...

  • Page 14: Before Use

    3. Before Use 3-1 Scope of Delivery Please confirm that the following items are included. ・NK-6 Symphony ........1 ・User’s Guide ..........1 (After explaining the instructions for use, hand it to the user.) ・Instruction Manual (this document) ..1 3-2 Assembly Procedure 3-2-1 Static alignment Perform static alignment according to the...

  • Page 15: Contact Of Socket At The Maximum Flexion Angle

    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. If the socket or the buttock is not in contact with the foot part, excessive load may be applied to the knee joint, thereby...

  • Page 16: Adjustment

    4. Adjustment 4-1 Adjusting the Stance Phase Control 4-1-1 Adjusting the stance-flexion rubber For adjustment of the stance phase control, adjust stiffness stance-flexion rubber. ▪ Adjust the adjusting screw shown in Fig. 9 with a 3 mm hexagonal wrench. ▪ Turning the screw clockwise increases the stiffness and decreases the degree of bouncing.

  • Page 17: Adjusting The Extension Assist Spring

    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 18: Adjusting The Swing Phase Control

    4-2 Adjusting the Swing Phase Control To adjust the swing phase control, select appropriate flexion 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. As shown in Fig.
  • Page 19 Front link Hydraulic cylinder Flexion adjusting valve (F) Fig. 11 Location of the Flexion Adjusting Valve Reference mark Max. resistance Min. resistance Nabt ESCO Fig. 12 Graduated Scale of the Flexion Adjusting Valve Extension adjusting valve (E) Fig. 13 Location of the Extension Adjusting Valve Reference mark Min.

  • Page 20: Operation Procedures And Precautions

    5. 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 21: Procedures For Operating The Selective Lock

    (NK-6+L, NK-6SH+L) 5-2 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 22: Precautions For Operating The Selective Lock

    (NK-6+L, NK-6SH+L) 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 CAUTION starting to walk. To operate the selective lock, slide the switch surely to the position shown in Fig.

  • Page 23: Precautions When Sitting In And Standing Up From A Chair

    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. When standing up from a chair, never place the hand on the knee.

  • Page 24: Troubleshooting

    6. Troubleshooting Items to be Status Countermeasures checked The self-lock Check if body weight Teach the user how to cannot be is applied properly. fully apply body weight activated even if to the heel. the stance- Check for proper Adjust the alignment so flexion rubber is alignment.

  • Page 25: Maintenance

    7. 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 26: Replacing The Stance-Flexion Rubber

    7-2 Replacing the Stance-Flexion Rubber If looseness or abnormal noise occurs when the self-lock is activated, replace the stance-flexion rubber *2 The stance-flexion rubber expendable. The rubber may deteriorate earlier under some use conditions. When replacing it, purchase the stance- flexion rubber replacement kit (N- G011(NORMAL) or N-G012(HARD)).

  • Page 27: Removing The Base Bracket Cover

    7-3 Removing the Base Bracket Cover Remove the Base bracket cover by following procedures when replacing the extension stopper rubbers stance-flexion rubber as described in 7-1 or 7-2. Spread the Base bracket cover sideling. Remove the whole of the cover toward the anterior direction.

  • Page 28: Outline Of The Product

    8. Outline of the Product ● Specifications Model No. NK-6 NK-6+L NK-6SH 6SH+L Proximal Male Pyramid Adapter Screw Head Connection Selective Lock – – Total Length 197mm 191mm A ref. 14mm 14.5mm measurement B ref. 156mm 156mm measurement Weight 920g 970g 960g 1010g...

  • Page 29: Disposal

    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 30: Symbols Used On Labels

    10. Symbols Used on Labels 10-1 UDI Label (Packing Box) Legal manufacturer Made date Medical device Item number Global Trade Serial number Item Number Authorized representative for EU countries The maximum and minimum temperatures for storing, transporting, and using the product. Declaration of conformity according to the European Regulation 2017/745 Single patient multiple use...
  • Page 31 MEMO P.29...
  • Page 32 Document Number: 81-SS00084E (ver.2) Data of issue: July 1, 2021 Nabtesco Corporation Manufacturer Nabtesco Corporation Accessibility Innovations Company Assistive Products Department 35, Uozakihama-machi Higashinada-ku Kobe, Japan 658-0024 TEL: +81-78-413-2724 FAX: +81-78-413-2725 https://welfare.nabtesco.com Authorized representative for EU countries PROTEOR SAS 6 rue de la Redoute...

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