Nabtesco HybridKnee NI-C3 Series Instruction Manual
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Nabtesco HybridKnee NI-C3 Series Instruction Manual

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Instruction Manual
(Nl-C3 Series)
Language: English
Introduction
Thank you for purchasing Nabtesco's Hybrid Knee.
Hybrid Knee is a totally new intelligent prosthetic knee joint
that integrates hydraulic and pneumatic control with com-
puter control to provide safe and pleasant walking.
For safe use, be sure to read this manual and familiarize
yourself with the Hybrid Knee. Carefully keep this manual
conveniently available for future reference.
Also read through the User's Guide and explain the safety
information contained therein to the patient before hand-
ing the User's Guide to him/her.

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Summary of Contents for Nabtesco HybridKnee NI-C3 Series

  • Page 1 Instruction Manual (Nl-C3 Series) Language: English Introduction Thank you for purchasing Nabtesco's Hybrid Knee. Hybrid Knee is a totally new intelligent prosthetic knee joint that integrates hydraulic and pneumatic control with com- puter control to provide safe and pleasant walking.

  • Page 2: Important Information

    WARNING Cautions for handling Hybrid Knee safely Nabtesco Corporation (hereinafter referred to as "Nabtesco") cannot foresee all potential re- sidual risks of Hybrid Knee and risks resulting from human errors and the usage environment. Although there are many instructions and prohibitions for handling Hybrid Knee (assem- bling, adjusting, and maintaining the prosthesis), all these matters cannot be described in this document or on the warning labels on the body of Hybrid Knee.

  • Page 3: About This Document

    It covers the following references: NI-C311, NI-C311s, NI-C313, NI-C313s. Copyright Nabtesco owns the copyright for this document. You are not permitted to duplicate any part of drawings or technical documents including this document by any means (copying or re- cording on electronic media) without our prior authorization.

  • Page 4: Table Of Contents

    Table of Contents Important Information About This Document Table of Contents 1 Safety Precautions 1-1 Contraindications 1-2 Definition of Symbols 1-3 Mandatory Precautions 1-4 Compatible Medical Devices (Prosthesis Components) 2 Certification of International Standard 3 Basic Construction and Operational Principle 3-1 Basic Construction 3-2 Operational Principle 3-3 Stance Phase Control...

  • Page 5: Safety Precautions

    Safety Precautions Contraindications The following users cannot use Hybrid Knee. • Persons who cannot understand how to use the knee and the precautions for use • Persons experiencing pain in the amputated limb • Persons who weigh over 125 kg (or over 100 kg for highly-active users) •...

  • Page 6: Mandatory Precautions

    Mandatory Precautions WARNING Be sure to hand the Upon detecting any separate User's Guide abnormal noise, directly to the user and looseness, or drop in Mandatory Mandatory explain precautions for hydraulic resistance, Action Action use. discontinue use and contact your local sales representative/dealer.

  • Page 7: Compatible Medical Devices (Prosthesis Components)

    CAUTION Be sure to attend the Be sure to undergo operation training course periodic inspection every offered by your local sales two years. Mandatory Mandatory Action Action representative/dealer. If Hybrid Knee is used without inspection, parts can become worn down more quickly. Incorrect adjustment can prevent pleasant walking.

  • Page 8: Certification Of International Standard

    Certification of International Standard Structural durability Hybrid Knee was tested for 3 million walking cycles with a load of 125 kg which corresponds to the average walking distance for 3 years. We will not assume liability for ageing or damage of the product due to long-term usage.
  • Page 9 Declaration of Conformity Nabtesco Corporation hereby declares that the following Class I medical device complies with the essential health and safety requirements of the REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical devices, amend- ing Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC.

  • Page 10: Basic Construction And Operational Principle

    Basic Construction and Operational Principle Basic Construction Hybrid Knee has Hydraulic rotary Knee plate damper a c c o m p l i s h e d Rotary axis sophisticated in- (Knee axis) tegration of the MRS system Proximity sensor hydraulic rotary Adjusting plug...

  • Page 11: Stance Phase Control

    Stance Phase Control When the knee is flexed, the hydraulic rotary damper produces hydraulic resistance, (Mechanism of Reaction Force Sensing) thus preventing abrupt buckling. The system mechanically detects floor reaction force and sets hydraulic resistance to be ON or OFF. When floor reaction force exists at the heel side from the sensing point, hydraulic resistance is turned on.

  • Page 12: Swing Phase Control

    Swing Phase Control The microprocessor calculates the time for one walking cycle by using data on knee joint flexion as detected by the proximity sensor. Also, this microprocessor stores a maximum of 10 stages of adjustment data, which consists of the cadence and reac- tion force of the pneumatic cylinder, for each patient.
  • Page 13 ● When walking stops When the patient stops walking for 8 seconds or more, the needle valve is automat- ically set to his/her normal cadence. ● When the battery is running low When the remaining battery power is low, the needle valve is automatically set to the normal cadence of the patient.

  • Page 14: Before Use

    Before Use Scope of Delivery Please confirm that the following items are included. • Hybrid Knee ........1 • Dedicated lithium battery ....1 (already set) • User’s Guide ........1 (After explaining the content, hand it directly to the patient.) • Instruction Manual (this book) ...1 Assembly Procedure 4-2-1 Static Alignment Perform static alignment according to...

  • Page 15: Assembling The Tube

    4.5 to 5 N∙m. Outer clamp Inner clamp For safe use, you are recom- mended to use the tube made by Nabtesco. If you absolutely CAUTION must use one made by anoth- Clamping bolt er manufacturer, be sure to use...

  • Page 16: Precautions On Socket Forming

    4-2-4 Precautions on Socket Forming When making the socket, make sure that neither the socket nor parts touch the pneumatic cylinder when the knee joint is flexed to the fullest extent. Failure to do so may cause damage to the pneumatic cylinder, adversely affect- CAUTION ing the function.

  • Page 17: Adjustment

    Adjustment Adjusting the Stance Phase Control First, adjust the stance phase control. The hydraulic damper has two kinds of adjusting plugs, which are to be used as shown in Hydraulic resistance Fig. 10 and Table 1. adjusting plug Hydraulic sensitivity adjusting plug Fig.

  • Page 18: Adjusting The Hydraulic Resistance

    IMPORTANT The adjusting plugs have been set to the positions which are common to most people in the factory default setting. If you can not find suitable positions, turn the plugs to their original position. Hydraulic resistance adjusting plug: Set to the scale 10. Hydraulic sensitivity adjusting plug: Set to the scale 15.
  • Page 19 Procedure Make sure that the scale reads 10 and then have the patient stand within parallel bars. (Fig. 12) Have the patient place his/her weight on the prosthesis and confirm that the yielding function works properly. → See POINT 1 Have the patient feel two different levels of yielding strength by adjusting the scale as follows.

  • Page 20: Walking On A Level Floor

    Provide appropriate alignment, selection of a foot part, and gait training so that the patient can sufficiently apply his/her body weight to the heel. When the heel load is insufficient, the yielding function may not be sustained. CAUTION POINT 2 Guide for Intensity of Hydraulic Resistance •...

  • Page 21: Adjusting Sensitivity (Off-Timing)

    5-1-3 Adjusting Sensitivity (OFF-timing) Referring to Table 1 (see page 16), perform sensitivity adjustment. Sensitivity is set to the standard condition by factory default. When no problem exists, adjustment is unnecessary. Referring to the figure below, turn the sensitivity adjusting plug on the right-hand side by using a hex wrench.

  • Page 22: Adjusting The Swing Phase Control

    You must use the specialized cable included with the programming unit. The pro- Note gramming unit must not be used for other devices besides the Nabtesco Intelligent Knee series. An improper connection could cause failures of the products. Tape...
  • Page 23 KEY EXPLANATION [MED] Medium Walking Speed [SLOW] [FAST] Slow Walking Speed Fast Walking Speed [DOWN] [UP] Decreases the data Increases the data [POWER] [SPEED] Measures walking speed and calculates Turns the device on and off, and changes average speed the mode [CLEAR] Clears data and cancels a multistage setting [RESET] (on top-side)
  • Page 24 ADJUSTING PROCEDURES a. ADJUSTING MODE To program the swing phase control of the knee unit, base line data should be collected by having the user walk at the Medium, Slow, and Fast speeds. Normally, programming for a knee unit can be accomplished only using this mode. Operating Key Display Operation Procedure...
  • Page 25 b. CONFIRMATION MODE This mode allows you to check the programmed data in the knee unit. When the user walks, the current valve position can be displayed. Operating Key Display Operation Procedure Connect the programming unit to the knee joint. ◎...
  • Page 26 d. COPY MODE Use Copy Mode to transfer stored data from one knee to another such as a loaned unit. Operating Key Display Operation Procedure Connect the programming unit to the knee unit. Press and hold ◎ ◎ "POWER" and "SPEED" simultaneously. HELLO! Wait for approximately one second.
  • Page 27 f. EXTENSION MODE For fine adjustment of programming, use Extension Mode. In this mode, the roles of the keys are changed as follows; "SLOW" Key → [SELECT], "MED" Key → [ENTER], "FAST" Key → [SAVE] Operating Key Display Operation Procedure Connect the programming unit to the knee unit.
  • Page 28 　 ERROR MESSAGES AND TROUBLESHOOTING ● ERROR MESSAGES Message displayed: KNEE JOINT LOW BATTERY When Cause Solution Turning on the power. Depleted battery of the knee joint. Replace the battery of the knee joint. Special Note: This message will be displayed when voltage of the battery in the knee joint is low. This message may not appear if the knee unit has been left on for a long period of time.
  • Page 29 ● TROUBLESHOOTING Use the following information if there is any trouble during any phase of use. Problem Cause Solution No display appears when power A) Battery of the programming unit A) Connect the battery correctly. supply is turned on. not connected to unit properly. B) Replace the battery.

  • Page 30: Adjusting The Terminal Impact

    5-2-2 Adjusting the Terminal Impact When undesiable terminal impact occurs, adjust the cushion valve located above the pneumatic cylinder using the following procedure: As shown in Fig. 16, turn the cushion valve with a hex wrench (2 mm). Clockwise: Cushion effect is enhanced and impact is reduced. Counterclockwise: Cushion effect is weakened and impact is increased.
  • Page 31 POINT 3 Guide to Cushion Adjustment • Cushion adjustment should be made in consideration of the swing strength of each patient. As a general rule, however, set a value within the marked range. • The factory default set- ting is 1 turn to the left from the fully closed po- sition.

  • Page 32: Adjusting Yielding For Descending A Slope Or Stairs

    Adjusting Yielding for Descending a Slope or Stairs Before descending a slope or stairs, perform fine adjustments of hydraulic resistance and sensitivity. Before using the prosthesis for walking on a slope or stairs, perform gait training. If appropriate use of yielding is deemed difficult after gait training, use of the yielding function should be prohibited.
  • Page 33 Procedure ● Adjustment for descending a slope • Adjustment of hydraulic resistance Select an appropriate strength of hydraulic resistance suitable for the angle of the de- clining slopes where the patient walks in his/her daily life. → See 5-1-1 (page 17). •...

  • Page 34: Precautions When Sitting In And Standing Up From A Chair

    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 pneumatic cylinder, causing serious injury. WARNING •...

  • Page 35: Troubleshooting

    Troubleshooting Status Items to be checked Countermeasures Even if hydraulic resistance is ad- Check if body weight is being ap- Practice how to sufficiently apply justed to a higher level, yielding plied properly. body weight to the heel. strength is not increased. POINT 1 →...
  • Page 36 Status Items to be checked Countermeasures When the patient descends stairs, Check if the floor contact position of Put the mid-foot on the edge of the yielding does not function. the foot is appropriate. stairs. POINT 4 → See (page 32). * Check if the toe touches the floor Swing the prosthesis to fully extend first due to insufficient knee exten-...

  • Page 37: Maintenance

    Maintenance Replacing the Extension Stopper Rubber While flexing the knee joint approximately 90°, remove the extension stopper rubber. As double-sided tape is attached on the back of the extension stopper rubber, it is recommended to use a sharp-pointed stick to remove the rubber. Remove dirt and dust from the inside of the groove.

  • Page 38: 7-2Replacing The Battery

    Replacing the Battery ● Replace the battery using the following procedure: Be sure to eliminate static electricity by, for example, touching a desk before starting this work. CAUTION Remove the battery connector from the circuit board (Fig. 21). Battery connector Circuit board connector Fig.
  • Page 39 Turn the cap on the battery case using a coin, and remove the battery. (Figs. 23 and 24). Lithium battery Inner clamp Battery case Fig. 23 Removing the Battery Cap Fig. 24 Removing the Battery Insert a new battery into the battery case. Note: When inserting a battery, align the battery wire with the slit of an in- ner clamp.

  • Page 40: 7-3Replacing The Cylinder Module

    Disposal of Batteries Dispose of used batteries strictly in accordance with regulations of the local gov- ernment concerned. (This product uses a lithium battery.) Replacing the Cylinder Module ● Removing the cylinder module Pull out the battery connector from the circuit board. Remove the clevis bolt and the trunnion pin (Fig.
  • Page 41 Clevis bolt Trunnion pin Trunnion pin Proximity sensor connector (behind the circuit board) Fig. 25 Removing/Installing the Cylinder Module...

  • Page 42: Outline Of The Product

    Outline of the Product ● Specifications Type NI-C311/NI-C311s NI-C313/NI-C313s Overall 296 mm 292 mm length Ａ 51 mm 45 mm Ｂ 247 mm 247 mm Ｃ 38 mm 38 mm Weight 1,375 g 1,385 g Knee flexion angle Max. 140° 125 kg Patient's body （100 kg for highly-active users）...

  • Page 43: Disposal

    When disposing of the knee joint, comply with the rules stipulated in the local com- munity. If you return it to Nabtesco after notifying us, we will dispose of it for you. Do not discard the lithium battery with general household garbage. If thrown away, the battery could short-circuit and ignite or release harmful fumes.

  • Page 44: Periodic Inspection And Warranty

    Periodic Inspection and Warranty ● Periodic inspection • Undergo a periodic inspection every 2 years. Inspections for the 2nd year are free of charge, and inspections for the 3rd year and following years are offered on a charged basis. • Consumable parts (extension stopper rubber, battery) are available for purchase. Be sure to undergo a periodic inspection every 2 years.

  • Page 45: Symbols Used

    ( 0 1 ) 0 4 5 6 2 2 0 4 1 8 0 1 2 3 ( 1 1 ) 2 1 0 6 1 7 ( 2 1 ) C F 2 5 1 0 9 Nabtesco Corporation...

  • Page 46: Tightening Torque Label (Knee Joint Body)

    11-4 Tightening Torque Label (Knee Joint Body) Tighten the clamp within this torque range. 11-5 Lithium Battery Label (Battery) It certifies that this product complies with UL safety standards. The EU requires recycling without disposal in a landfill. When disposing of this product, fol- low the rules of the local government.
  • Page 47 MEMO...
  • Page 48 Document Number: 81-SS00076 (ver.3) Date of issue: 2021-11-01 Language: English Manufacturer Authorized representative for EU countries Nabtesco Corporation PROTEOR SAS Accessibility Innovations Company 6 rue de la Redoute 21850 Saint-Apollinaire Assistive Products Department France 35, Uozakihama-machi, Higashinada-ku Phone: +33-3-80-78-42-42 KOBE, 658-0024, JAPAN...

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Ni-c311

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