Nabtesco Symphony NK-6 User manual

NK6 Symphony Knee
User’s Guide -
for Users
Distributeur

EN
NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users 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 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.
Keep it handy for future reference.

EN
NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users4
Important Information
Intended purpose of NK-6 Symphony
NK-6 Symphony was designed and is manufactured for use as an articial knee
joint by above-knee, knee disarticulation, and 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 specications for NK-6 Symphony, see 4. Outline of the Product.
Do not use NK-6 Symphony outside of the specication 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.

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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users 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 suciently
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 User’s Guide - For Users6
About This Document
Target of this document
This document is intended for the prosthetic user of NK-6 Symphony.
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 User’s Guide - For Users 7
Contents
1. Safety Precautions ................................................................................................................... 8
1.1 Contraindications ................................................................................................................ 8
1.2 Denition of Symbols .......................................................................................................... 8
1.3 Mandatory Precautions ....................................................................................................... 9
2. Basic Construction and Operational Principle .............................................................. 13
2.1 Basic Construction ............................................................................................................. 13
2.2 Operational Principle ......................................................................................................... 13
3. Before Use ............................................................................................................................... 14
3.1 How to Activate the “Stance-Flexion” Function ............................................................... 14
3.2 Procedures for Operating the Selective Lock (Optional Function) ................................ 15
3.3 Precautions for Operating the Selective Lock ................................................................. 16
3.4 Precautions When Sitting in and Standing up from a Chair ........................................... 17
3.5 Precautions When Wiping Surface Dirt ............................................................................ 18
4. Troubleshooting ..................................................................................................................... 19
5. Outline of the Product .......................................................................................................... 20
6. Disposal .................................................................................................................................... 22
7. Symbols Used .......................................................................................................................... 24
7.1 UDI Label (Packing Box) ..................................................................................................... 24
7.2 Body Mass Limit Label (Knee Joint Body) ......................................................................... 25
7.3 Product Type Label (Knee Joint Body) .............................................................................. 25

EN
NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users8
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 Denition 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 specic action.
Indicates obligation of a specic action.
CAUTION

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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users 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.
DO NOT undertake any maintenance actions on the device. Maintenance must be
carried out by a professional at least every 2 years.

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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users10
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.
Specic 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 van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users 11
Safety Precautions
1
CAUTION
DO NOT put
anything on the
product. DO NOT
step on it.
Parts may be damaged.
PROHIBITION
DO NOT put the
product in a high
place. DO NOT place
it against something
in an unstable state.
The product may drop or fall
down, thereby causing damage
to parts.
PROHIBITION
Instructions for storage 
DO NOT leave the
product in a place
where it may be
exposed to water
or moisture.
Parts may rust, thereby causing
failure.
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

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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users12
Do not use the
product near open
ame or where
the temperature
exceeds 50°C.
The plastic parts may be
deformed, thereby causing failure.
PROHIBITION
Do not use the
product where
the outdoor
temperature is
lower than –20°C.
The lubricant and rubber parts
may harden, thereby causing
failure.
PROHIBITION
Instructions for use 
DO NOT contact
liquids such as
water, salt water,
chlorinated water,
soapy water, gel
soap, body uids
and exudates.
DO NOT use any
detergent or solvent
(thinner) for
cleaning it.
Parts may rust, thereby causing
failure.
PROHIBITION
DO NOT jump down
from a high place
nor play active
sports to
intentionally give
strong impact to the
product.
Parts may be damaged, thereby
causing a fall.
PROHIBITION
Safety Precautions
1

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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users 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
stiness
adjusting screw
Selective lock
(optional)
6-bar linkage
(p-MRS system)
Extension assist
spring adjusting
screw

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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users14
Before Use
3
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 gure while the knee is completely
extended, the knee is automatically locked (self-locked) and slightly exed
(stanceexion). The maximum exion angle is 10° depending on the loading method
and the setting of the adjustment. If the weight is placed on the toe as shown in the
right gure, the lock is released.
Fig. 3 - Dierences in the Self-Lock function depending on oor reaction force
Until getting used to use the product, place your weight on the prosthesis
while holding on the parallel bars, and conrm the self-locking function.
Thoroughly understand the mechanism and the function prior to use.
In a standing posture, put the prosthesis slightly forward, and weight on the
heel while fully extending the knee. If the weight is placed when the knee is
not fully extended or prior to toe-o, knee buckling may occur, and the user
may fall down. Particularly users who have a habit of standing with their
prostheses slightly backward shall keep this in mind.
VOORZICHTIG
CAUTION
VOORZICHTIG
CAUTION

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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users 15
Before Use
3
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 o. However, the lock switch cannot be
operated while the knee is exed. The joint can be locked when the knee is fully
extended.
[ Locking procedure ]
As shown in Fig. 4, slide the lock switch in front of the knee plate in the arrow
direction.
[ Unlocking procedure ]
As shown in Fig. 5, slide the lock switch in front of the knee plate in the arrow
direction.
Knee plate
Lock switch
Fig. 4 - Locking Procedure
Fig. 5 - Unlocking Procedure
3.2 Procedures for Operating the Selective Lock (Optional Function)

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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users16
Before Use
3
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.
[ Precautions for unlocking operation ]
[ Cosmetic foam cover ]
Note that the cosmetic foam cover may be broken depending on the way of
operating the selective lock if the lock is used with the cover tted.
VOORZICHTIG
CAUTION
To operate the selective lock, slide the switch surely to the position shown in
Fig. 4. (A click will sound.) Although the lock can be activated before the
position shown in Fig. 4, the lock parts may be damaged if the product is
used in such a state.
VOORZICHTIG
CAUTION
After releasing the selective lock, make sure that the knee can be normally
exed before starting to walk.
VOORZICHTIG
CAUTION
To release the selective lock, slide the switch surely to the position shown in
Fig. 5. (A click will sound.) The lock cannot be released if the switch is stopped
before the position shown in Fig. 5. Slide it correctly.
VOORZICHTIG
CAUTION

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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users 17
Before Use
3
3.4 Precautions When Sitting in and Standing up from a Chair
Fig. 6 - Recommended Posture When 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.
Fingers can be caught between the knee plate and the front link, causing
serious injury. For ease of standing up from a chair, placing hands on
the armrests or on the seating face* is recommended.
* In addition to the above, placing a hand on the socket or placing both
hands on the sound leg also facilitate standing up from a chair. Provide
instructions on the safe method according to the user’s circumstances.
VOORZICHTIG
CAUTION

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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users18
Before Use
3
3.5 Wiping O 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
aect the bending and stretching of the knee.
VOORZICHTIG
CAUTION

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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users 19
Troubleshooting
4
Status Items to be
checked Countermeasures
The self-lock cannot be
activated.
Check if body weight is applied
properly.
Practice how to fully apply
body weight to the heel.
Check for proper alignment. Adjust the alignment so that
body weight can be fully
applied to the heel
(See 3-2-1).
Check if the foot is appropriate. Select a foot with which body
weight can be fully applied to
the heel.
The above measures cannot
resolve the problem.
Contact your prosthetist.
The joint does not fully
extend before the heel
contacts to the ground.
Check if the adjusting valve
(E) on the extension side of
the hydraulic cylinder is not
tightened excessively.
Contact your prosthetist.
The self-lock is not
released unintentionally,
thereby causing sticking.
Check if smooth heel-to-toe
weight shift is achieved while
walking.
Practice how to walk to
place sucient load on the
toe when pushing o the
prosthesis.
The above measures cannot
resolve the problem.
Contact your prosthetist.
The selective lock cannot
be activated.
Check if the knee joint is fully
extended.
When operating the switch,
fully extend the knee.
Check if the cosmetic foam
cover is not involved.
Take care that the cosmetic
foam cover is not caught.
The above measures cannot
resolve the problem.
Contact your prosthetist.
Abnormal noise or
rattling occurred.
Check if a foreign object is
caught in the moving part.
Remove it if possible.
The above measures cannot
resolve the problem.
Contact your prosthetist.

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NK6 Symphony Knee van Nabtesco, distributeur Loth Fabenim B.V.
NK6 Symphony Knee User’s Guide - For Users20
Outline of the Product
5
Model No. NK-6 NK-6+L NK-6SH NK-6SH+L
Proximal
Connection Male Pyramid Adapter Screw Head
Selective Lock - o - o
Total Length 197 mm 191 mm
A
ref. measurement 14 mm 14.5 mm
B
ref. measurement 156 mm 156 mm
Weight 920 g 970 g 960 g 1010 g
Max. Knee
Flexion Angle 170°
Material Titanium & Aluminum
Max. Body
Weight
125kg (100kg For Hip Prosthesis & High Active User)
Compliance with ISO 10328 P6(A-125kg)
Mobility Grade Active ~ High Active (K-Level 3+4, Mobility Class 3+4)
These specications are subject to changes without prior notice.
Specications