Nabtesco Symphony NK-6 User manual
NK6 Symphony Knee
Instruction Manual -
for Prosthetist
Distributeur
EN
NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee Instruction Manual - For Prosthetists 3
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.
EN
NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee Instruction Manual - For Prosthetists4
Important Information
Intended purpose of NK-6 Symphony
NK-6 Symphony was designed and is manufactured for use as an articial knee joint
by above-knee, knee disarticulation, hip disarticulation. Do not use NK-6 Symphony
for any other purposes.
For hip prostheses, it is recommended to use a torsion adapter to prevent application
of large torsion to NK-6 Symphony.
This device is intended for single patient multiple use.
For the specications for NK-6 Symphony, see 8. Outline of the Product.
Do not use NK-6 Symphony outside of the specication range. Do not modify
the main body or parts. 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.
Although there are a lot of instructions and prohibitions for handling NK-6 Symphony
(assembling, adjusting and maintaining the prosthesis), all these matters cannot be
described in this document or on the warning labels on the body of NK-6 Symphony.
Therefore, when handling NK-6 Symphony, it is necessary not only to observe the
precautions stated in this document, but also to take safety measures necessary for
prosthesis knee joint.
Particularly important matters concerning the safe handling of NK-6 Symphony are
described below. These matters apply to the persons who assemble and adjust
NK-6 Symphony.
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NK6 Symphony Knee Instruction Manual - For Prosthetists 5
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.
Read this document thoroughly
Before handling NK-6 Symphony, thoroughly read this document, and suciently
understand the contents. Strictly observe the safety precautions stated in the
document.
EN
NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee Instruction Manual - For Prosthetists6
About This Document
Target of this document
This document is intended for the prosthetists to t 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 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.
When you have questions about the copyright of this document for copy or
reference, contact Loth Fabenim.
When 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 NK-6 Symphony without this document can cause accidents.
Information
The information on this manual is subject to change without prior notice for product
improvement.
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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee Instruction Manual - For Prosthetists 7
Contents
1. Safety Precautions ................................................................................................................... 8
1.1 Contraindications ................................................................................................................ 8
1.2 Denition of Symbols .......................................................................................................... 8
1.3 Mandatory Precautions ....................................................................................................... 9
1.4 Compatible medical devices (prosthesis components) ................................................. 12
2. Basic Construction and Operational Principle .............................................................. 13
2.1 Basic Construction ............................................................................................................. 13
2.2 Operational Principle ......................................................................................................... 13
2.3 Stance Phase Control ........................................................................................................ 14
2.4 Swing Phase Control .......................................................................................................... 15
3. Before Use ............................................................................................................................... 16
3.1 Scope of Delivery ............................................................................................................... 16
3.2 Assembly Procedure .......................................................................................................... 16
3.2.1 Static alignment ........................................................................................................ 16
3.2.2 Contact of socket at the maximum exion angle .................................................. 17
4. Adjustment .............................................................................................................................. 18
4.1 Adjusting the Stance Phase Control ................................................................................. 18
4.1.1 Adjusting the stance-exion rubber ....................................................................... 18
4.1.2 Adjusting the extension assist spring .................................................................... 19
4.2 Adjusting the Swing Phase Control .................................................................................. 20
4.2.1 Adjusting the exion resistance of hydraulic cylinder .......................................... 20
4.2.2 Adjusting the extension resistance of hydraulic cylinder .................................... 20
5. Operation Procedures and Precautions ......................................................................... 23
5.1 How to Activate the “Stance-Flexion” Function ............................................................... 23
5.2 Procedures for Operating the Selective Lock .................................................................. 24
5.3 Precautions for Operating the Selective Lock ................................................................. 25
5.4 Precautions When Sitting in and Standing up from a Chair ........................................... 26
6. Troubleshooting ..................................................................................................................... 27
7. Maintenance ............................................................................................................................ 29
7.1 Replacing the Extension Stopper Rubber ........................................................................ 29
7.2 Replacing the Stance-Flexion Rubber .............................................................................. 30
7.3 Removing the Base Bracket Cover ................................................................................... 31
7.4 Wiping O Dirt on the Surface .......................................................................................... 31
8. Outline of the Product .......................................................................................................... 32
9. Disposal .................................................................................................................................... 34
10. Symbols Used on Labels ..................................................................................................... 36
10.1 UDI Label (Packing Box) .................................................................................................. 36
10.2 Body Mass Limit Label (Knee Joint Body) ....................................................................... 37
10.3 Product Type Label (Knee Joint Body) ............................................................................ 37
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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee Instruction Manual - For Prosthetists8
Safety Precautions
1
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 Denition of Symbols
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
WARNING
PROHIBITION
MANDATORY
ACTION
Indicates a potentially hazardous situation which, if
not avoided, may result in minor or moderate injury or
property damage.
Indicates a general caution to be observed.
Indicates prohibition of a specic action.
Indicates obligation of a specic action.
CAUTION
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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee Instruction Manual - For Prosthetists 9
Safety Precautions
1
1.3 Mandatory Precautions
WARNING
Hand the separate
User’s Guide to the
user and explain the
instructions for use.
MANDATORY
ACTION
Upon detecting any abnormal noise, play, or drop in
hydraulic resistance, discontinue use and contact your
local sales representative/dealer.
MANDATORY
ACTION
MANDATORY
ACTION
Improper use can cause a fall or
injury.
We do not warrant the product
against damage caused by use
for any unintended purpose.
Continued use despite a detected abnormality may cause damage of parts,
leading to a fall.
This product shall
be used as a
prosthetic knee
joint. Never use it
for other purposes.
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NK6 Symphony Knee Instruction Manual - For Prosthetists10
Safety Precautions
1
DO NOT use for a
person who weighs
over 125 kg.
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. If used to
a person who weighs over
125 kg, damage of parts may
occur, leading to a fail. This,
however, does not preclude
loading and unloading of
baggage, etc. occurring in daily
life.
Specic condition: For persons on
a high activity level and persons
wearing a hip prosthesis, the
weight limit shall be 100 kg.
PROHIBITION
DO NOT place the
hand behind the
knee when exing
the knee.
DO NOT touch the
knee when
extending it.
Never attempt to
disassemble or
modify the knee
joint.
Your hand can be caught, thereby
causing injury.
Parts may be damaged, thereby
causing a fall.
PROHIBITION
PROHIBITION
Never attempt to
heat or put in a re
Risk of re or explosion.
PROHIBITION
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NK6 Symphony Knee Instruction Manual - For Prosthetists 11
Safety Precautions
1
CAUTION
Make adjustments
in accordance with
the adjustment
procedures
stated in the
Instruction Manual.
MANDATORY
ACTION
DO NOT contact liquids such as water, salt water, chlorinated
water, soapy water, gel soap, body uids an exudates.
DO NOT use any detergent or solvent (thinner) for cleaning it.
Improper adjustments may result
in poor performance.
Could result in rusting, discoloration, desiccation of the grease, could result in
a malfunction and abnormal noises.
PROHIBITION
Do not store the
product where the
temperature
may exceed the
range of
-20 to 50°C.
Parts may be deteriorated or
deformed, thereby causing
failure.
PROHIBITION
DO NOT drop parts
such as a screw in
the frame.
Continued use after any part is
dropped may cause damage of a
pneumatic cylinder, impending
normal walking.
PROHIBITION
When making a
socket, ensure that
the socket or the
buttock is in contact
with the foot part
at the maximum
exion angle.
MANDATORY
ACTION
If the socket or the buttock is not
in contact with the foot part,
excessive load may be applied to
the knee joint, thereby causing
damage of parts.
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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee Instruction Manual - For Prosthetists12
Safety Precautions
1
1.4 Compatible medical devices (prosthesis components)
Symphony Reference NK-6 / NK-6+L NK-6SH / NK-6SH+L
Proximal connectors
Female
pyramidal
connectors
M36 screw
connectors
Distal connectors
Female
pyramidal
connectors
Female
pyramidal
connectors
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NK6 Symphony Knee Instruction Manual - For Prosthetists 13
Basic Construction and Operational Principle
2
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.
(Model: NK-6+L, NK-6SH+L)
2.2 Operational Principle
The geometric self-locking system reliably functions while the prosthesis is in
contact with the oor, thus preventing abrupt buckling. When the prosthesis
leaves the oor, the hydraulic cylinder functions, providing cadence responsive
swing control.
Stance-Flexion Hydraulic cylinder
Fig. 2 - Walking on a Level Floor
Fig. 1 - Main Components
Hydraulic cylinder
Stance-exion
rubber
Stance-exion
stiness
adjusting screw
Selective lock
(optional)
6-bar linkage
(p-MRS system)
Extension assist
spring adjusting
screw
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NK6 Symphony Knee Instruction Manual - For Prosthetists14
Basic Construction and Operational Principle
2
2.3 Stance Phase Control
Stance-Flexion
The knee joint provides a stance flexion during from the
heel-contact to the midstance. This feature results in
absorbing shocks at the heel-strike and reducing bobbing
of center-of-mass. The amount of the stance flexion can be
easily adjusted to maximum 10°.
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. If the floor reaction force is applied on the heel side
from the sensing point, the knee joint geometrically locks
the knee flexion, and if it is applied on the toe side from the
sensing point, the lock is released. Since the stance phase is
controlled according to the position of the floor reaction
force, the stance phase control works reliably at a low heel
contact load and is released smoothly at the push-off stage.
This leads to the user’s relief and smooth shifting to the
swing phase.
Fig. 3 - p-MRS System
Fig. 4 - Stance-Flexion
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NK6 Symphony Knee Instruction Manual - For Prosthetists 15
Basic Construction and Operational Principle
2
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 exed 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 exion angle
is 40° or more. This provides the user a comfortable walking and less fatigue as if
wearing a pneumatic knee joint, and also powerfully response to various walking
speeds.
High
pressure
in flexion
High
pressure in
extension
High
pressure
in exion
High
pressure
in extension
Fig. 5 - Swing Phase
Fig. 6 - Hydraulic Resistance
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NK6 Symphony Knee Instruction Manual - For Prosthetists16
Before Use
3
3.1 Scope of Delivery
Please conrm 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 following procedure.
Alignment of frontal plane
Complete alignment so that the load line passes through the center of the
knee joint and falls in the heel center of the foot section.
Alignment of sagittal plane
As shown in Fig. 7, complete alignment so that the weight load line passes
through the center of the knee axis of the knee joint within a deviation of
±5 mm (0 mm recommended).
Improper alignment may result in poor
self-lock performance. Excess load
applied to the parts may accelerate wear.
For users who wear hip prostheses and
play any sports such as golf, use of a
torsion adapter is recommended. If the
adapter is not used, large torsion force
will be applied to the prosthesis, and
wear of parts may be accelerated.
Fig. 7 - Statistic Alignment
Center of
the frontal
upper axis
±5 mm
(0mm
recommended)
VOORZICHTIG
CAUTION
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NK6 Symphony Knee Instruction Manual - For Prosthetists 17
±5 mm
(0mm
recommended)
Before Use
3
3.2.2 Contact of socket at the maximum exion 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 exed at the maximum exion 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 causing damage of parts.
While making a prosthesis, do not touch the knee joint when the knee is
exed and extended. Your hand can be caught, thereby causing injury.
VOORZICHTIG
The socket must not
be in contact with the
knee joint.
The socket must
be in contact with
the foot part and
the pipe adapter.
The socket must
be in contact
with the foot
part and
the pipe
adapter.
The socket must
not be in
contact with the
knee joint.
Fig. 8 - Contact of socket at the maximum exion angle
CAUTION
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NK6 Symphony Knee Instruction Manual - For Prosthetists18
Adjustment
4
4.1 Adjusting the Stance Phase Control
4.1.1 Adjusting the stance-exion rubber
For adjustment of the stance phase control, adjust the stiness of the stance-exion
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. Turning it counterclockwise decreases the stiffness and
increases the degree of bouncing.
If the stiness of the stance-exion rubber is too high, the self-lock may not
work properly. Adjust the stiness appropriately to the body weight and/or
the impact at the heel strike.
Do not loosen the adjusting screw until its head is lower than the bottom
of the pyramid (sealing surface). Doing so may drop the screw.
* When the head of the adjusting screw is set on the same level as the
pyramid bottom, the stiness of the stance-exion rubber is lowest.
Adjusting
screw
Decrease stiness
Increase stiness
Stance-exion rubber
Fig. 9 - How to Adjust
Stance-Flexion Stiness
The adjusting screw has been set to a
position which is common to most
people in the factory default setting.
When you are unable to nd a
suitable position, turn the screw to
reset the position to the standard
setting shown below.
Standard setting: A position obtained
by turning the screw fully clockwise to
tighten and loosening it 3.5 turns.
IMPORTANT
VOORZICHTIG
CAUTION
VOORZICHTIG
CAUTION
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Adjustment
4
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 oor.
Adjust the adjusting bolt shown in Fig. 10 with a 2.5 mm hexagonal wrench.
To increase the extension assist force, turn the bolt clockwise. To reduce the
force, turn it counterclockwise.
If the extension assist force is too low for the prosthesis, there is a possibility
of landing with the knee exed, and the user may fall down due to knee
buckling.
Adjust the spring so that the foot can contact to the ground with the knee fully
extended. The adjusting screw has stoppers between the maximum and minimum
positions. It can be adjusted in the range of about four turns.
If the adjusting bolt is turned to an excessively high torque, it may be
damaged.
Increase stiness
Decrease stiness
Adjusting bolt
Extension assist
spring
Fig. 10 - How to Adjust the
Extension Assist Spring
The adjusting screw has been set to a
position which is common to most
people in the factory default setting.
When you are unable to nd a
suitable position, turn the screw to
reset the position to the standard
setting shown below.
Standard setting: A position obtained
by 3 turning counterclockwise from
fully tightened position.
IMPORTANT
VOORZICHTIG
CAUTION
VOORZICHTIG
CAUTION
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NK6 Symphony Knee Instruction Manual - For Prosthetists20
Adjustment
4
4.2 Adjusting the Swing Phase Control
To adjust the swing phase control, select appropriate exion and extension
resistances using the two adjusting valves of the hydraulic cylinder.
4.2.1 Adjusting the exion resistance of hydraulic cylinder
At rst, adjust the exion resistance. As shown in Fig. 11, the exion adjusting valve
(F) is located on the right when viewed from the user. As shown in Fig. 12, the scale
is graduated from “1” to “8”. “1” corresponds to the highest hydraulic resistance, and
“8” corresponds to the lowest.
(Reference) Factory default: “8” To adjust the valve, use a 2 mm hexagonal wrench.
Insert the wrench from the lowest hole in the front link side face.
4.2.2 Adjusting the extension resistance of hydraulic cylinder
If terminal impact occurs at the end of the swing phase, adjust the extension
resistance. As shown in Fig. 13, the extension adjusting valve (E) is located on the
left when viewed from the user. As shown in Fig. 14, the scale is graduated from “1”
to “8”. “1” corresponds to the highest hydraulic resistance, and “8” corresponds to
the lowest.
(Reference) Factory default: “8” To adjust the valve, use a 2 mm hexagonal wrench.
Insert the wrench from the center hole in the front link side face.
If the extension resistance is set too high, the knee does not extend fully,
thereby causing falling.
This hydraulic cylinder is intended for swing phase control. Do not use it for
any other purpose. If the prosthesis is used under overload, for example, by
applying the body weight at a high exion resistance, it may be damaged.
VOORZICHTIG
CAUTION
VOORZICHTIG
CAUTION
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5
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3
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