Nabtesco HybridKnee NI-C3 Series User manual

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.
(Nl-C3 Series)
Instruction Manual
Language: English

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Important Information
Intended purpose of Hybrid Knee
Hybrid Knee was designed and is manufactured for use as a prosthetic knee joint by above-
knee amputated, knee disarticulated, and hip disarticulated patients. Do not use Hybrid
Knee for any other purposes. For hip prostheses, it is recommended to use a torsion adapter
to prevent significant torsion from being applied to Hybrid Knee. This device is intended for
single patient multiple use.
For the specifications for Hybrid Knee, see 8. Product Overview.
WARNING
■Do not use Hybrid Knee outside of the specification range. Do not modify the
main body or parts.
Doing so can cause injury or damage Hybrid Knee.
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.
Therefore, when handling Hybrid Knee, it is necessary not only to observe the precautions stat-
ed in this document, but also to take the safety measures necessary for a prosthesis knee joint.
Particularly important matters concerning the safe handling of Hybrid Knee are described
below. These matters apply to the persons who assemble and adjust Hybrid Knee.
If you have a serious incident related to Hybrid Knee, please report it to the manufacturer
(contact information on the back cover) and the competent authority in your country.
Read this document thoroughly
Before handling Hybrid Knee, thoroughly read this document, and sufficiently understand
the contents. Strictly observe the safety precautions stated in the document.
Qualification of assemblers and adjusters
Anyone assembling or adjusting Hybrid Knee must have attended Hybrid Knee license semi-
nars and be a licensed prosthetist. Outsourcing to anyone else is strictly prohibited.

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About This Document
Target of this document
This document is intended for the persons (prosthetists, etc.) who have attended and com-
pleted Hybrid Knee license seminars to fit the product for prosthetic users.
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.
If you have questions about the copyright of this document for copying or referencing, con-
tact Nabtesco.
If this document is lost or damaged
If this document or any related document is lost or damaged, immediately ask the local sales
representative or distributor (hereinafter referred to as the "Distributor") to reissue it.
Handling Hybrid Knee without this document can cause accidents.
Information
The information in this manual is subject to change without prior notice for product im-
provement.

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Table of Contents
Important Information 1
About This Document 2
Table of Contents 3
1 Safety Precautions 4
1-1 Contraindications 4
1-2 Definition of Symbols 4
1-3 Mandatory Precautions 5
1-4 Compatible Medical Devices (Prosthesis Components) 6
2 Certification of International Standard 7
3 Basic Construction and Operational Principle 9
3-1 Basic Construction 9
3-2 Operational Principle 9
3-3 Stance Phase Control 10
3-4 Swing Phase Control 11
4 Before Use 13
4-1 Scope of Delivery 13
4-2 Assembly Procedure 13
4-2-1 Static Alignment 13
4-2-2 Assembling the Tube 14
4-2-3 Inserting the Battery Connector 14
4-2-4 Precautions on Socket Forming 15
5 Adjustment 16
5-1 Adjusting the Stance Phase Control 16
5-1-1 Adjusting the Hydraulic Resistance 17
5-1-2 Walking on a Level Floor 19
5-1-3 Adjusting Sensitivity (OFF-timing) 20
5-2 Adjusting the Swing Phase Control 21
5-2-1 Adjusting the Hydraulic Resistance 21
5-2-2 Adjusting the Terminal Impact 29
5-3 Adjusting Yielding for Descending a Slope or Stairs 31
5-4 Precautions When Sitting in and Standing up from a Chair 33
6 Troubleshooting 34
7 Maintenance 36
7-1Replacing the Extension Stopper Rubber 36
7-2Replacing the Battery 37
7-3Replacing the Cylinder Module 39
8 Outline of the Product 41
9 Disposal 42
10 Periodic Inspection and Warranty 43
11 Symbols Used 44
11-1 UDI Label (Packing Box) 44
11-2 Body Mass Limit Label (Knee Joint Body) 44
11-3 Product Type Label (Knee Joint Body) 44
11-4 Tightening Torque Label (Knee Joint Body) 45
11-5 Lithium Battery Label (Battery) 45

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1-1 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)
• Persons who engage in sports that put a significant burden on the knee
1-2 Definition of Symbols
WARNING
Indicates a potentially hazardous situation which, if
this symbol is not observed, could result in serious
injury.
CAUTION
Indicates a potentially hazardous situation which, if
this symbol is not observed, could result in minor or
moderate injury or property damage.
Indicates a general caution to be observed.
Prohibition
Indicates prohibition of a specific action.
Mandatory
Action
Indicates obligation to perform a specific action.
1Safety Precautions

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Be sure to hand the
separate User's Guide
directly to the user and
explain precautions for
use.
Improper use can cause falling or injury.
DO NOT use for a person
who weighs over 125 kg.
If used for a person who weighs over 125
kg, damage of parts may occur, leading to
falling. This, however, does not preclude
loading and unloading of baggage, etc. oc-
curring in daily life.
*For K4 individuals, the weight limit is
100 kg.
Never attempt to
disassemble or modify
Hybrid Knee.
Failure to observe this warning can cause
breakage of parts, leading to falling.
Upon detecting any
abnormal noise,
looseness, or drop in
hydraulic resistance,
discontinue use and
contact your local sales
representative/dealer.
Continued use despite a detected abnor-
mality may cause damage of parts, leading
to falling.
DO NOT place the hand
behind the knee when
flexing the knee.
DO NOT touch the knee
when extending it.
The hand can be caught, causing injury.
DO NOT attempt to
charge, disassemble,
heat, or short-circuit the
battery, and DO NOT
dispose of it in a fire.
Failure to observe this warning can cause
an explosion or fire.
1-3 Mandatory Precautions
WARNING
Prohibition
Prohibition
Prohibition
Prohibition
Mandatory
Action
Mandatory
Action

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1-4 Compatible Medical Devices
(Prosthesis Components)
Hybrid Knee reference NI-C311, NI-C311s NI-C313, NI-C313s
Proximal connectors Female pyramidal connectors M36 screw connectors
Distal connectors φ34 tube adapter φ34 tube adapter
Be sure to attend the
operation training course
offered by your local sales
representative/dealer.
Incorrect adjustment can prevent pleasant
walking.
A socket should be formed
and aligned so that
neither the socket nor any
other part contacts the
pneumatic cylinder at the
maximum flexion angle.
It will damage the pneumatic cylinder, im-
peding normal walking.
DO NOT allow contact
with liquids such as water,
salt water, chlorinated
water, soapy water, gel
soap, bodily fluids, and
exudations. DO NOT use
any detergent or solvent
(thinner) for cleaning.
Doing so could result in rusting, discolor-
ation, desiccation of the grease, resulting
in a malfunction and abnormal noises.
Be sure to undergo
periodic inspection every
two years.
If Hybrid Knee is used without inspection,
parts can become worn down more quickly.
DO NOT drop parts such
as a screw in the frame.
Continued use after any part is dropped
will damage the pneumatic cylinder, im-
peding normal walking.
DO NOT leave or store in
an environment with a
temperature of less than
-20°C/-4°F or more than
+60°C/140°F
Doing so could result in a malfunction.
CAUTION
Prohibition
Prohibition
Prohibition
Prohibition
Mandatory
Action
Mandatory
Action

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2Certification 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.
*For products with an extended warranty, the replacement of structural parts during period-
ic inspections is covered by the warranty.
ISO10328-P6-125kg*)
*) The body mass limit is not to be exceeded. For specific conditions and lim-
itations of use, see the manufacturer’s written instructions on intended
use.
K Level (MOB)
K2 Level (MOB2): User can handle small environmental barriers such as curbs, steps, or un-
even ground, both indoors and around the home.
K3 Level (MOB3): User can handle most environmental barriers, and can walk at different
speeds. In addition to simple walking, he/she can do light work and exer-
cise as well.
K4 Level (MOB4): User has physical abilities higher than basic walking. This includes children
and athletes.
EMC Information
Hybrid Knee belongs to Group 1 and Class A equipment in accordance with IEC/EN60601-1-2.
Hybrid Knee requires special precautions regarding EMC (Electromagnetic Compatibility)
and need to be installed, put into service, and used according to the following information.

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CAUTION
■Do not use any cables other than the cables that are provided or specified by
the manufacturer, Nabtesco Corporation.
■Do not use any chargers, accessories, or peripheral devices except those sold
by Nabtesco Corporation.
Doing so may increase the emission of, or decrease the resistance to, electro-
magnetic waves of Hybrid Knee.
■Do not use Hybrid Knee near other electronic equipment. Portable and mobile
RF communications equipment can affect Hybrid Knee. If you must use Hybrid
Knee near such equipment, be sure to ensure safety.
■Please carefully read this instruction manual to avoid the risk of ignition or
electric shock.
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.

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3Basic Construction and
Operational Principle
3-1 Basic Construction
Hybrid Knee has
accomplished
sophisticated in-
tegration of the
hydraulic rotary
damper to control
the stance phase,
the MRS system,
and the micropro-
cessor-controlled
pneumatic cylin-
der for the swing
phase.
3-2 Operational Principle
The hydraulic rotary damper reliably functions while the prosthesis is in contact with
the floor, thus preventing abrupt buckling. When the prosthesis leaves the floor, the
microprocessor-controlled pneumatic cylinder functions, providing swing control
that responds to cadence.
Hydraulic rotary
damper Pneumatic
cylinder
Fig. 2 Level Floor
Carbon frame
Hydraulic rotary
damper
MRS system
Adjusting plug
(See page 16.)
Knee plate
Rotary axis
(Knee axis)
Proximity sensor
Pneumatic
cylinder
Battery
Printed
circuit board
Stepping motor
Cushion valve
Swing phase control section
Stance phase control section
Fig. 1 Main Components