Nabtesco ALLUX NE-Z4 User manual

Manufacture
Nabtesco Corporation
Accessibility Innovations Company
Assistive Products Department
35,Uozakihama-machi,Higashinada-ku
KOBE,658-0024,JAPAN
Phone: [phone]
Fax: [phone]
http://welfare.nabtesco.com/
Authorized representative for EU contries
ORTHO-REHA Neuhof GmbH
Gundelfinger Straße 6
90451 Nürnberg, GERMANY
TEL: [phone]
FAX: [phone]
Please contact us if you find any page missing or disordered.
Contact
Product Type：NE－Z4，NE－Z4SH
Document Number：81-SS00099E
Date of issue：June 1.2017
■Carefully read the User’s Guide prior to use.
■Keep this User’s Guide for future reference.
User’s Guide
CAUTION
TM
TM

Introduction
Important Information
Thank you for purchasing Nabtesco ALLUXTM.
ALLUXTM is an electronically controlled Prosthetic knee joint with four-bar linkage
which provides safe and comfortable walking through a combination of hydraulic
control and computer control.
This user's guide (hereinafter referred to as this document) was produced by
Nabtesco Corporation to ensure safe and comfortable use of the ALLUX™.
This document describes matters concerning typical usage such as fitting and
walking, maintenance, trouble shooting and cautionary notes that anyone utilizing
the ALLUX™ needs to know.
Introduction
Purpose of ALLUXTM
ALLUX™ was designed and is manufactured for use as an artificial knee joint by
above-knee, knee disarticulation, and hip disarticulation. Do not use ALLUXTM for
any other purposes. For hip prostheses, it is recommended to use a torsion
adapter to prevent application of large torsion to ALLUXTM.
For the specifications for ALLUXTM, see 2.Product Overview.
Before handling ALLUXTM, thoroughly read this document, and sufficiently understand
the contents. Strictly observe the safety precautions stated in the document.
Cautions for handling ALLUXTM safely
Read this document thoroughly
Only the persons who have received ALLUXTM license seminar are allowed to
assemble and adjust it. If necessary, inquire your ALLUXTM certified prosthetist.
Qualification of assemblers and adjusters
Nabtesco Corporation (hereinafter, referred to as Nabtesco) cannot foresee all of potential
residual risks of ALLUX
TM
and risks resulting from human errors and usage environment.
Although there are a lot of instructions and prohibitions for handling ALLUXTM
(assembling, adjusting and maintaining the prosthesis), all these matters cannot be
described in this document or on the warning labels on the body of ALLUXTM.
Therefore, when handling ALLUXTM, 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 ALLUXTM are described
below.
■Do not use ALLUXTM outside of the specification range. Do not
modify the main body or parts.
Doing so can cause injury or damage ALLUXTM.
WARNING
Important Information
iALLUXTM User’s Guide

Introduction
Important Information
Thank you for purchasing Nabtesco ALLUXTM.
ALLUXTM is an electronically controlled Prosthetic knee joint with four-bar linkage
which provides safe and comfortable walking through a combination of hydraulic
control and computer control.
This user's guide (hereinafter referred to as this document) was produced by
Nabtesco Corporation to ensure safe and comfortable use of the ALLUX™.
This document describes matters concerning typical usage such as fitting and
walking, maintenance, trouble shooting and cautionary notes that anyone utilizing
the ALLUX™ needs to know.
Introduction
Purpose of ALLUXTM
ALLUX™ was designed and is manufactured for use as an artificial knee joint by
above-knee, knee disarticulation, and hip disarticulation. Do not use ALLUXTM for
any other purposes. For hip prostheses, it is recommended to use a torsion
adapter to prevent application of large torsion to ALLUXTM.
For the specifications for ALLUXTM, see 2.Product Overview.
Before handling ALLUXTM, thoroughly read this document, and sufficiently understand
the contents. Strictly observe the safety precautions stated in the document.
Cautions for handling ALLUXTM safely
Read this document thoroughly
Only the persons who have received ALLUXTM license seminar are allowed to
assemble and adjust it. If necessary, inquire your ALLUXTM certified prosthetist.
Qualification of assemblers and adjusters
Nabtesco Corporation (hereinafter, referred to as Nabtesco) cannot foresee all of potential
residual risks of ALLUX
TM
and risks resulting from human errors and usage environment.
Although there are a lot of instructions and prohibitions for handling ALLUXTM
(assembling, adjusting and maintaining the prosthesis), all these matters cannot be
described in this document or on the warning labels on the body of ALLUXTM.
Therefore, when handling ALLUXTM, 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 ALLUXTM are described
below.
■Do not use ALLUXTM outside of the specification range. Do not
modify the main body or parts.
Doing so can cause injury or damage ALLUXTM.
WARNING
Important Information
ii
ALLUXTM User’s Guide

Structure of This Document
This document consists of the following chapters.
Structure of This Document
About This Document
Target of this document
This document is intended for the persons (prosthetists, etc.) who have attended
and completed ALLUXTM license seminar to fit the product for prosthetic users.
Copyright
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 Nabtesco.
The information on this manual is subject to change without prior notice for product
improvement.
Information
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 ALLUXTM without this document can cause accidents.
About This Document
iii ALLUXTM User’s Guide

Structure of This Document
This document consists of the following chapters.
Structure of This Document
About This Document
Target of this document
This document is intended for the persons (prosthetists, etc.) who have attended
and completed ALLUXTM license seminar to fit the product for prosthetic users.
Copyright
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 Nabtesco.
The information on this manual is subject to change without prior notice for product
improvement.
Information
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 ALLUXTM without this document can cause accidents.
About This Document
iv
ALLUXTM User’s Guide
Title of chapter Contents
Introduction Outline and purposes of this document
Important information Purpose of use, information for safe handling of ALLUXTM
About This Document Notes on this document
Structure of This Document Contents of each chapter in this document
1. Safety precautions Safety precautions
2. Product Overview Specifications for ALLUXTM
3. Before use Names and models of ALLUXTM and accessories
4. Safe posture Explanation about how to take the safe posture
5. Selective mode by
remote controller Explanation of Selective modes by remote controller
6. Remote controller maintenance How to change the battery and attach the strap
7. States of ALLUXTM Explanation of states of ALLUXTM and vibration alert patterns
8. Charging Procedure Charging procedure for ALLUXTM
Charging the backup battery
9. Maintenance Parts Explanation of service parts
10. Troubleshooting Methods for confirming to improve feeling
11. Disposal Explanation about method of disposal of ALLUXTM
12. Periodic inspection Explanation about periodic inspection and warranty period
13. Warranty Explanation about warranty

Table of Contents
Table of Contents
Table of Contents
Table of Contents
vALLUXTM User’s Guide
Introduction 󰼽
Important Information 󰼾
About This Document 󰼿
Structure of This Document  󰽀
Table of Contents  󰽁
1 Safety Precautions
1.1 De󳞛nitions of symbols  
1.2 Warning 
1.3 Caution 
1.4 Notice  
2 Product Overview
2.1 Overview of ALLUXTM  
2.2 Basic structure  
2.3 Certi󳞛cation of International Standard  
2.4 Speci󳞛cations  
3 Before Use
3.1 Parts list  
4 Safe Posture
4.1 Safe posture and condition ready for communication  
5 Selective modes by remote controller
5.1 ALLUXTM operational modes 
5.2 Operation with the remote controller 
5.3 Normal mode  
5.3.1 Overview 
5.3.2 Yield function 
5.3.3 Walking speed auto-adjust function 
5.3.4 Seated position 
5.3.5 Safety lock 
5.4 Flexion angle limit mode 
5.5 Variable selective 󳞜exion lock mode 
5.6 Full extension lock mode 
5.7 Free swing mode
5.8 Not in use mode (battery level con󳞛rmation) 
6 Remote controller maintenance
6.1 How to change batteries 
6.2 How to attach strap 

Table of Contents
Table of Contents
Table of Contents
Table of Contents
vi
ALLUXTM User’s Guide
7 States of ALLUXTM
7.1 States of ALLUXTM
7.2 Normal use state
7.2.1 When charger or power OFF cap is disconnected 
7.2.2 When power is turned off for charging
7.2.3 Use of backup battery
7.2.4 Battery exhaustion (zero battery)
7.2.5 In high-temperature state 
7.3 In case of malfunction 
7.4 Vibration alert pattern chart 
8 Charging Procedures
8.1 Charging ALLUXTM 
8.1.1 Speci󳞛cations for charger and AC adapter
8.1.2 Charging procedures
8.1.3 Charging the backup battery
8.1.4 Indication by LED lamp on charger 
8.1.5 Use of extension cable
9 Maintenance Parts
9.1 List of maintenance parts
10 Troubleshooting
10.1 Troubleshooting list
11 Disposal
12 Periodic Inspection
12.1 Periodic inspection 
13 Warranty
13.1 Warranty
13.2 Warranty periods of designated devices
13.3 Repair 

1
Safety Precautions
1
Safety Precautions
1.1 Definition of symbols
Throughout this manual, the following signal words are used to classify and explain the hazards
and damages which may be caused by improper usage not conforming to the instructions.
As protective measure above-mentioned, the instructions to be observed are classified
and explained by using the following pictograms.
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not
avoided, could result in minor or moderate injury.
Damage only.
Safety Precautions
1
NOTICE
Indicates actions that you must not do when handling
the product.
Indicates actions that you must do based on instructions
when handling the product.
WARNING
CAUTION
1.2 Warning
Strictly observe the following instructions to use the product safely.
■Please ensure to read the notes on usage.
Incorrect use, the parts could be damaged or broken, thus resulting in a fall.
■When detecting abnormal noise, play or reduction in hydraulic
resistance, discontinue the use, and contact the Distributor.
Use when it feels abnormal, the parts could be damaged or broken, thus
resulting in a fall.
■Do not use for a user who weighs more than 125 kg.
Use when the weight limit is exceeded, the parts could be damaged or
broken, thus resulting in a fall.
■Do not use if the user is not in a condition to use the prosthesis knee joint.
This could get aggravation of symptoms.
■Do not use for sports.
■Do not use for any purpose other than prosthesis knee joint.
The parts could be damaged or broken, thus resulting in a fall.
■When bending the prosthesis knee joint, do not put your
hand behind the knee.
■When extending the prosthesis knee joint, do not touch the knee.
This can cause injury from your hand being caught in the
knee joint.
WARNING
1.3 Caution
Strictly observe the following instructions to use the product safely.
1.4 Notice
Strictly observe the following instructions.
NOTICE
■The adjustment of ALLUXTM must be done by a certified prosthetist
of ALLUXTM handling.
Incorrect adjustment could impair walking safety and comfort.
■Charge the main body of ALLUXTM before using it.
Normal walking will be impossible if the battery runs out during use.
■After adjusting it in the communication state for a long time, charge it.
Communication requires more power and thus depletes the battery faster.
■Adjust ALLUXTM in an environment with a temperature from 0℃
/+32℉ to +40℃/+104℉(Recommended:+20℃/+68℉)
The temperature can affect the flex/extension resistance.
■Do not put a magnet closer or use in a magnetic field or in an
environment with strong electromagnetic waves(e.g. MRI).
Could result in a malfunction.
■ Do not give a strong impact to the product by dropping it from a height.
The parts could be damaged or broken, thus resulting in a fall.
■Do not use in an environment with a temperature of less than
-10℃/+14℉or more than +40℃/+104℉
The flexural extension resistance may change, resulting in a fall.
■Do not charge with anything other than the designated charger.
Abnormal voltage use, could result in a malfunction.
■Never attempt to disassemble or modify the product.
The parts could be damaged or broken, thus resulting in a fall.
1Safety Precautions
■Never attempt to disassemble, heat, short-circuit or put the
battery in a fire.
Could result in deforming the plastic parts, could result in a malfunction.
■Do not immerse the product in liquids, such as water and
seawater, or pour any liquid over it.
Could result in rusting etc. of the parts, could result in a malfunction.
■Do not use any detergent or solvent (thinner) for cleaning it.
Discoloration, desiccation of the grease, and abnormal noises.
■Do not leave or store in an environment with a temperature of
less than -20℃/-4℉ or more than +60℃/140℉
■Do not charge outdoors.
Could result in a malfunction.
CAUTION
1ALLUXTM User’s Guide

1
Safety Precautions
1
Safety Precautions
1.1 Definition of symbols
Throughout this manual, the following signal words are used to classify and explain the hazards
and damages which may be caused by improper usage not conforming to the instructions.
As protective measure above-mentioned, the instructions to be observed are classified
and explained by using the following pictograms.
Indicates a potentially hazardous situation which, if not
avoided, could result in death or serious injury.
Indicates a potentially hazardous situation which, if not
avoided, could result in minor or moderate injury.
Damage only.
Safety Precautions
1
NOTICE
Indicates actions that you must not do when handling
the product.
Indicates actions that you must do based on instructions
when handling the product.
WARNING
CAUTION
1.2 Warning
Strictly observe the following instructions to use the product safely.
■Please ensure to read the notes on usage.
Incorrect use, the parts could be damaged or broken, thus resulting in a fall.
■When detecting abnormal noise, play or reduction in hydraulic
resistance, discontinue the use, and contact the Distributor.
Use when it feels abnormal, the parts could be damaged or broken, thus
resulting in a fall.
■Do not use for a user who weighs more than 125 kg.
Use when the weight limit is exceeded, the parts could be damaged or
broken, thus resulting in a fall.
■Do not use if the user is not in a condition to use the prosthesis knee joint.
This could get aggravation of symptoms.
■Do not use for sports.
■Do not use for any purpose other than prosthesis knee joint.
The parts could be damaged or broken, thus resulting in a fall.
■When bending the prosthesis knee joint, do not put your
hand behind the knee.
■When extending the prosthesis knee joint, do not touch the knee.
This can cause injury from your hand being caught in the
knee joint.
WARNING
1.3 Caution
Strictly observe the following instructions to use the product safely.
1.4 Notice
Strictly observe the following instructions.
NOTICE
■The adjustment of ALLUXTM must be done by a certified prosthetist
of ALLUXTM handling.
Incorrect adjustment could impair walking safety and comfort.
■Charge the main body of ALLUXTM before using it.
Normal walking will be impossible if the battery runs out during use.
■After adjusting it in the communication state for a long time, charge it.
Communication requires more power and thus depletes the battery faster.
■Adjust ALLUXTM in an environment with a temperature from 0℃
/+32℉ to +40℃/+104℉(Recommended:+20℃/+68℉)
The temperature can affect the flex/extension resistance.
■Do not put a magnet closer or use in a magnetic field or in an
environment with strong electromagnetic waves(e.g. MRI).
Could result in a malfunction.
■ Do not give a strong impact to the product by dropping it from a height.
The parts could be damaged or broken, thus resulting in a fall.
■Do not use in an environment with a temperature of less than
-10℃/+14℉or more than +40℃/+104℉
The flexural extension resistance may change, resulting in a fall.
■Do not charge with anything other than the designated charger.
Abnormal voltage use, could result in a malfunction.
■Never attempt to disassemble or modify the product.
The parts could be damaged or broken, thus resulting in a fall.
1Safety Precautions
■Never attempt to disassemble, heat, short-circuit or put the
battery in a fire.
Could result in deforming the plastic parts, could result in a malfunction.
■Do not immerse the product in liquids, such as water and
seawater, or pour any liquid over it.
Could result in rusting etc. of the parts, could result in a malfunction.
■Do not use any detergent or solvent (thinner) for cleaning it.
Discoloration, desiccation of the grease, and abnormal noises.
■Do not leave or store in an environment with a temperature of
less than -20℃/-4℉ or more than +60℃/140℉
■Do not charge outdoors.
Could result in a malfunction.
CAUTION
2
ALLUXTM User’s Guide

●Certification of International Standard
ALLUXTM 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.
*for products with extended warranty: Exchange of structural parts is covered by the warranty.
●EMC Information
ALLUXTMbelongs to Group 1 and Class A equipment in accordance with IEC/EN60601-1-2.
ALLUXTMrequires special precautions regarding EMC (Electromagnetic Compatibility) and
need to be installed, put into service and used according to the following information.
●Declaration of Conformity
Nabtesco Corporation, hereby declare that following Class I medical device complies
with the essential health and safety requirements of the Medical Devices Directive
93/42/EEC as amended by 2007/42/EC and the R&TTE(Radio and Telecommunications
Terminal Equipment) Directive 1999/5/EC.
■Do not use any cables other than the cables that provided or
specified by the manufacturer, Nabtesco Corporation.
■Do not use the peripheral devices other than those specified, with the
exception of transducers and cables sold by Nabtesco Corporation as
replacement parts for internal components.
That may result in increased emissions or decreased immunity of the ALLUX
TM
.
■Do not use ALLUXTM adjacent to other equipment. Portable and
mobile RF communications equipment can affect the ALLUXTM. If
adjacent use is necessary, take care.
■Please carefully read this instruction manual to avoid the risk of
ignition or electric shock.
CAUTION
ISO10328 - P6 -125kg*）
Body mass limit not to be exceeded. For specific conditions and limitations of
use see manufacturer’s written instructions on intended use.
*）
●K Level(MOB)
K1 Level(MOB1): User can move to a bed or chair, and can walk on a flat surface indoors
at a constant speed.
K2 Level(MOB2): User can handle small environmental barriers such as curbs, steps, or
irregular 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 exercise as well.
K4 Level(MOB4): User has physical abilities higher than basic walking; children, athletes, etc.
2Product Overview
2.3 Certification of International Standard
2
Product Overview
2
Product Overview
2.1 Overview of ALLUXTM
ALLUXTM is a knee joint with a four-Bar linkage mechanism to electronically control
the stance and swing phases. It provides smooth walking according to the walking
speed and enables yielding required for descending a slope or stairs. The safety
lock function can be used to stop the knee suddenly bending and as an
anti-stumbling function for when the toes get stubbed on the ground etc. The
internal power supply supports use of the prosthesis for 5000 steps per day over a
period of 4 days(Only a guide as it can vary with the usage conditions).
2.2 Basic structure
ALLUXTM has a pyramid adapter at the bottom and either a pyramid or threaded
adapter at the top. The frame is made of carbon, and the link parts are made of an
aluminum alloy. The stance and swing phase control is performed by a hydraulic
cylinder.
Product Overview
2
Pyramid or threaded type
Link part
Inner battery
Charging connector
Microproccessor
Hydraulic cylinder
Frame
Pyramid adaptor
3ALLUXTM User’s Guide

●Certification of International Standard
ALLUXTM 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.
*for products with extended warranty: Exchange of structural parts is covered by the warranty.
●EMC Information
ALLUXTMbelongs to Group 1 and Class A equipment in accordance with IEC/EN60601-1-2.
ALLUXTMrequires special precautions regarding EMC (Electromagnetic Compatibility) and
need to be installed, put into service and used according to the following information.
●Declaration of Conformity
Nabtesco Corporation, hereby declare that following Class I medical device complies
with the essential health and safety requirements of the Medical Devices Directive
93/42/EEC as amended by 2007/42/EC and the R&TTE(Radio and Telecommunications
Terminal Equipment) Directive 1999/5/EC.
■Do not use any cables other than the cables that provided or
specified by the manufacturer, Nabtesco Corporation.
■Do not use the peripheral devices other than those specified, with the
exception of transducers and cables sold by Nabtesco Corporation as
replacement parts for internal components.
That may result in increased emissions or decreased immunity of the ALLUX
TM
.
■Do not use ALLUXTM adjacent to other equipment. Portable and
mobile RF communications equipment can affect the ALLUXTM. If
adjacent use is necessary, take care.
■Please carefully read this instruction manual to avoid the risk of
ignition or electric shock.
CAUTION
ISO10328 - P6 -125kg*）
Body mass limit not to be exceeded. For specific conditions and limitations of
use see manufacturer’s written instructions on intended use.
*）
●K Level(MOB)
K1 Level(MOB1): User can move to a bed or chair, and can walk on a flat surface indoors
at a constant speed.
K2 Level(MOB2): User can handle small environmental barriers such as curbs, steps, or
irregular 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 exercise as well.
K4 Level(MOB4): User has physical abilities higher than basic walking; children, athletes, etc.
2Product Overview
2.3 Certification of International Standard
2
Product Overview
2
Product Overview
2.1 Overview of ALLUXTM
ALLUXTM is a knee joint with a four-Bar linkage mechanism to electronically control
the stance and swing phases. It provides smooth walking according to the walking
speed and enables yielding required for descending a slope or stairs. The safety
lock function can be used to stop the knee suddenly bending and as an
anti-stumbling function for when the toes get stubbed on the ground etc. The
internal power supply supports use of the prosthesis for 5000 steps per day over a
period of 4 days(Only a guide as it can vary with the usage conditions).
2.2 Basic structure
ALLUXTM has a pyramid adapter at the bottom and either a pyramid or threaded
adapter at the top. The frame is made of carbon, and the link parts are made of an
aluminum alloy. The stance and swing phase control is performed by a hydraulic
cylinder.
Product Overview
2
Pyramid or threaded type
Link part
Inner battery
Charging connector
Microproccessor
Hydraulic cylinder
Frame
Pyramid adaptor
4
ALLUXTM User’s Guide

2
Product Overview
3
Before Use
Before Use
3
NOTICE
3.1 Parts list
The package of ALLUXTM contains the following parts. Confirm whether everything
is included.
【Designated devices】
ALLUXTM
NE-Z4
Instruction manual
User’s Guide
1 pc.
1 copy
1 copy
1 pc.
81-SS00098E(for prosthetist)
81-SS00099E(this document)
Remote controller
NE-RC02
Charging port cap
NE-CC01
Power OFF cap
NE-CC02
Backup battery
NE-SB01
Extension cable
NE-CL02
Charger
NE-BC01
AC adapter
NE-AD01
Plug adapter（UL）
NE-PA01
Backup batterycharging cable
NE-CL01
1 pc.
1 pc.
1 pc.
1 pc.
1 pc.
1 pc.
1 pc.
1 pc.
1 pc.
【Main body and accessories】
■Do not use non-designated peripheral devices.
That might cause a crash of ALLUXTM.
Backup battery case
NE-SC01
2.4 Specifications
2Product Overview
●Type：NE-Z4 (pyramid), NE-Z4SH (threaded)
●Application range & Weight limit: ～K3(MOB3):125kg(275 lb)
K4(MOB4):100kg(220 lb)
●Weight: 1510g(NE-Z4)/1500g(NE-Z4SH)
●Maximum flexion angle: 155º
●Water resistance: IP42
●Internal power supply: Lithium ion battery
●Communication distance: Within 2 m
●Usage temperature: -10℃/+14℉ ～ +40℃/+104℉
■Note that with the above temperature operating range the hydraulic
resistance will decrease at higher temperatures and increase at lower
temperatures.
Normal walking will not be supported, possibly resulting in a fall.
CAUTION
A
B
C
D
E
F
G
295mm
30mm
268mm
15mm
21mm
76mm
16.5mm
287mm
22mm
266mm
15mm
21mm
68mm
14mm
NE-Z4SHNE-Z4
A
BG
D F
C
E
●D i m e n s i o n s ：
※ 1 inch = 25.4mm
※ The above specifications are subject to change without prior notice
for product improvement.
5ALLUXTM User’s Guide

2
Product Overview
3
Before Use
Before Use
3
NOTICE
3.1 Parts list
The package of ALLUXTM contains the following parts. Confirm whether everything
is included.
【Designated devices】
ALLUXTM
NE-Z4
Instruction manual
User’s Guide
1 pc.
1 copy
1 copy
1 pc.
81-SS00098E(for prosthetist)
81-SS00099E(this document)
Remote controller
NE-RC02
Charging port cap
NE-CC01
Power OFF cap
NE-CC02
Backup battery
NE-SB01
Extension cable
NE-CL02
Charger
NE-BC01
AC adapter
NE-AD01
Plug adapter（UL）
NE-PA01
Backup batterycharging cable
NE-CL01
1 pc.
1 pc.
1 pc.
1 pc.
1 pc.
1 pc.
1 pc.
1 pc.
1 pc.
【Main body and accessories】
■Do not use non-designated peripheral devices.
That might cause a crash of ALLUXTM.
Backup battery case
NE-SC01
2.4 Specifications
2Product Overview
●Type：NE-Z4 (pyramid), NE-Z4SH (threaded)
●Application range & Weight limit: ～K3(MOB3):125kg(275 lb)
K4(MOB4):100kg(220 lb)
●Weight: 1510g(NE-Z4)/1500g(NE-Z4SH)
●Maximum flexion angle: 155º
●Water resistance: IP42
●Internal power supply: Lithium ion battery
●Communication distance: Within 2 m
●Usage temperature: -10℃/+14℉ ～ +40℃/+104℉
■Note that with the above temperature operating range the hydraulic
resistance will decrease at higher temperatures and increase at lower
temperatures.
Normal walking will not be supported, possibly resulting in a fall.
CAUTION
A
B
C
D
E
F
G
295mm
30mm
268mm
15mm
21mm
76mm
16.5mm
287mm
22mm
266mm
15mm
21mm
68mm
14mm
NE-Z4SHNE-Z4
A
BG
D F
C
E
●D i m e n s i o n s ：
※ 1 inch = 25.4mm
※ The above specifications are subject to change without prior notice
for product improvement.
6
ALLUXTM User’s Guide

120
sec
120
sec
4
Safe Posture
5
Selective Modes by Remote Controller
4.1 Safe posture and condition ready for communication
‘Safe posture’ refers to the posture taken in order to change the mode before using
the remote controller or communicating with the ALLUXTM software. Be sure to
understand the following safe postures before using ALLUXTM.
■Do not take the posture in an unstable state. When taking the
safe posture without applying the body weight to ALLUXTM, hold a
handrail or sit down.
You may lose your balance and fall over.
CAUTION
5Selective Modes by Remote Controller
5.1 ALLUXTM operational modes
ALLUXTM has five operational modes.
1.Normal mode 2.Flexion angle limit mode 3.Variable selective flexion lock mode
4.Full extension lock mode 5.Free swing mode
Use the remote controller to change the operational modes. The optional buttons on the
remote controller can be customized as appropriate. Please consult your prosthetist.
4Safe Posture
In order to conserve power, ALLUXTM is not always in communication mode.
Communication mode is activated in ALLUXTM 120 seconds after lightly bending and
extending, or 120 seconds after removing your body weight and then applying it,or
120 seconds after disconnecting the charger or power OFF cap from ALLUXTM.
The operational mode can be selected with the remote controller (NE-RC02). To change
modes, hold the button on the remote controller for longer than 1.5 seconds within 120
seconds of bending and stretching your knee or removing your body weight and then
applying it while standing in safe posture. (See 6.1)
Press the '1' button on the remote control to return to normal mode. The remote
controller requires two AAA batteries. Please replace the batteries if the remote
controller does not work properly, or within 2 years.
●Assume safe posture. (See 4. Safe posture)
●Push an optional button (1-5) on the remote controller for over 1.5 seconds,
vibration will sound for 2 seconds.
●The selected mode is applied.
■Avoid malfunction of the remote controller
Unintentional switching of the mode could result in falling over.
*A vibratory alert will occur when the mode is switched. If an
unintentional vibratory alert occurs then ensure to verify whether a
remote control malfunction has occurred.
WARNING
5.2 Operation with the remote controller
Operational Modes
①Normal mode: normal walking --- button 1 or optional button
②Flexion angle limit mode: lock the knee at a designated angle --- optional button
③Variable selective flexion lock mode: lock the knee at the angle designated
by the remote controller --- optional button
④
Full extension lock mode: lock the knee at the fully extended position --- optional button
⑤ Free swing mode: maintain the least resistance against bending and stretching --- optional button
【Safe posture】
the state you stretch your knee straight with ALLUXTM and
may apply your body weight on it.
the state you do not apply your body weight on ALLUXTM and
may bend your knee.
NOTICE
■Please do not use the remote control anywhere radio waves are
prohibited, for example aircraft etc.
■Connecting and disconnecting the charger and power off cap will
result in the ALLUX™ returning to the normal mode set using the
'1' button on the remote control.
Please exercise caution as the status may differ before and after charging.
7ALLUXTM User’s Guide

120
sec
120
sec
4
Safe Posture
5
Selective Modes by Remote Controller
4.1 Safe posture and condition ready for communication
‘Safe posture’ refers to the posture taken in order to change the mode before using
the remote controller or communicating with the ALLUXTM software. Be sure to
understand the following safe postures before using ALLUXTM.
■Do not take the posture in an unstable state. When taking the
safe posture without applying the body weight to ALLUXTM, hold a
handrail or sit down.
You may lose your balance and fall over.
CAUTION
5Selective Modes by Remote Controller
5.1 ALLUXTM operational modes
ALLUXTM has five operational modes.
1.Normal mode 2.Flexion angle limit mode 3.Variable selective flexion lock mode
4.Full extension lock mode 5.Free swing mode
Use the remote controller to change the operational modes. The optional buttons on the
remote controller can be customized as appropriate. Please consult your prosthetist.
4Safe Posture
In order to conserve power, ALLUXTM is not always in communication mode.
Communication mode is activated in ALLUXTM 120 seconds after lightly bending and
extending, or 120 seconds after removing your body weight and then applying it,or
120 seconds after disconnecting the charger or power OFF cap from ALLUXTM.
The operational mode can be selected with the remote controller (NE-RC02). To change
modes, hold the button on the remote controller for longer than 1.5 seconds within 120
seconds of bending and stretching your knee or removing your body weight and then
applying it while standing in safe posture. (See 6.1)
Press the '1' button on the remote control to return to normal mode. The remote
controller requires two AAA batteries. Please replace the batteries if the remote
controller does not work properly, or within 2 years.
●Assume safe posture. (See 4. Safe posture)
●Push an optional button (1-5) on the remote controller for over 1.5 seconds,
vibration will sound for 2 seconds.
●The selected mode is applied.
■Avoid malfunction of the remote controller
Unintentional switching of the mode could result in falling over.
*A vibratory alert will occur when the mode is switched. If an
unintentional vibratory alert occurs then ensure to verify whether a
remote control malfunction has occurred.
WARNING
5.2 Operation with the remote controller
Operational Modes
①Normal mode: normal walking --- button 1 or optional button
②Flexion angle limit mode: lock the knee at a designated angle --- optional button
③Variable selective flexion lock mode: lock the knee at the angle designated
by the remote controller --- optional button
④
Full extension lock mode: lock the knee at the fully extended position --- optional button
⑤ Free swing mode: maintain the least resistance against bending and stretching --- optional button
【Safe posture】
the state you stretch your knee straight with ALLUXTM and
may apply your body weight on it.
the state you do not apply your body weight on ALLUXTM and
may bend your knee.
NOTICE
■Please do not use the remote control anywhere radio waves are
prohibited, for example aircraft etc.
■Connecting and disconnecting the charger and power off cap will
result in the ALLUX™ returning to the normal mode set using the
'1' button on the remote control.
Please exercise caution as the status may differ before and after charging.
8
ALLUXTM User’s Guide

In free swing mode, the knee is kept free.
If the remote controller button is set to not in use and the button is pressed then the ALLUX ™
mode will not change and the remaining power level will be indicated by vibration patterns instead.
( )
( )
Estimated number of steps※ Vibration patterns
1 second
x 4 times
1 second
x 3 times
1 second
x 2 times
0.5 seconds
× 8 times
About 30,000 steps
About 20,000 steps
About 10,000 steps
※Number of steps using the prosthesis, but double if both sides.
Only a guide as it can vary with the usage conditions.
5
Selective Modes by Remote Controller
5Selective Modes by Remote Controller
5Selective Modes by Remote Controller
ALLUXTM remembers the angle at which variable selective flexion lock mode is turned on.
Bending resistance is locked when it reaches that angle while extension resistance remains free.
In flexion angle limit mode, bending resistance is locked at a designated angle while
extension resistance remains free.
5.3 Normal Mode
5.4 Flexion angle limit mode
5.3.1 Overview
The normal mode is adjusted for normal walking. Judging various walking situations and normal
motions with the sensor, ALLUXTM automatically adjusts the bending or stretching resistance.
5.3.2 Yield Function
In the following situations, ALLUXTM yields, increasing bending resistance and
allowing knees to bend slowly.
Standing Sitting down Standing up Going downhillGoing down steps
5.3.4 Seated position
When in a seated position, ALLUXTM maintains no resistance in bending or stretching.
5.3.3 Walking speed auto-adjust function
ALLUXTM automatically adjusts the bending and stretching resistance according to walking speed.
0°～
100°
5.3.5 Safety lock
When under a burden and knees are bent continually for a few seconds, ALLUXTM locks
the bending resistance at a certain angle. (This function can be turned off or the
sensitivity can be adjusted.)
5
Selective Modes by Remote Controller
Knees are locked in a fully extended state.
To change modes using the remote
controller once locked, put your weight on
the ALLUXTM and then remove it.
Will soon no longer
be capable of walking.
5.5 Variable selective flexion lock mode
5.6 Full extension lock mode
5.8 Not in use mode (battery level confirmation)
5.7 Free swing mode
9ALLUXTM User’s Guide

In free swing mode, the knee is kept free.
If the remote controller button is set to not in use and the button is pressed then the ALLUX ™
mode will not change and the remaining power level will be indicated by vibration patterns instead.
( )
( )
Estimated number of steps※ Vibration patterns
1 second
x 4 times
1 second
x 3 times
1 second
x 2 times
0.5 seconds
× 8 times
About 30,000 steps
About 20,000 steps
About 10,000 steps
※Number of steps using the prosthesis, but double if both sides.
Only a guide as it can vary with the usage conditions.
5
Selective Modes by Remote Controller
5Selective Modes by Remote Controller
5Selective Modes by Remote Controller
ALLUXTM remembers the angle at which variable selective flexion lock mode is turned on.
Bending resistance is locked when it reaches that angle while extension resistance remains free.
In flexion angle limit mode, bending resistance is locked at a designated angle while
extension resistance remains free.
5.3 Normal Mode
5.4 Flexion angle limit mode
5.3.1 Overview
The normal mode is adjusted for normal walking. Judging various walking situations and normal
motions with the sensor, ALLUXTM automatically adjusts the bending or stretching resistance.
5.3.2 Yield Function
In the following situations, ALLUXTM yields, increasing bending resistance and
allowing knees to bend slowly.
Standing Sitting down Standing up Going downhillGoing down steps
5.3.4 Seated position
When in a seated position, ALLUXTM maintains no resistance in bending or stretching.
5.3.3 Walking speed auto-adjust function
ALLUXTM automatically adjusts the bending and stretching resistance according to walking speed.
0°～
100°
5.3.5 Safety lock
When under a burden and knees are bent continually for a few seconds, ALLUXTM locks
the bending resistance at a certain angle. (This function can be turned off or the
sensitivity can be adjusted.)
5
Selective Modes by Remote Controller
Knees are locked in a fully extended state.
To change modes using the remote
controller once locked, put your weight on
the ALLUXTM and then remove it.
Will soon no longer
be capable of walking.
5.5 Variable selective flexion lock mode
5.6 Full extension lock mode
5.8 Not in use mode (battery level confirmation)
5.7 Free swing mode
10
ALLUXTM User’s Guide

7
States of ALLUXTM
6Remote controller Maintenance
6.1 How to change batteries
When the battery power is depleted, exchange the AAA batteries as below. Please
make sure to change the batteries at least once a year.
6.2 How to attach strap
You can attach a strap to carry the remote controller with you. To attach a strap to
the remote controller, please follow the steps below.
7.1 States of ALLUXTM
ALLUXTM has charging mode, backup battery connecting mode, high-temperature mode,
battery empty mode. When the mode is changed, the vibration will notice the user about
the mode change and you can test the vibration patterns while adjusting the mode.
The internal power supply of ALLUXTM was designed to last for 4 days and the
number of steps taken by the prosthesis is 5000/day. When the remaining battery
time is less than 3 hours, an alert will be given by vibration. If the backup battery is
connected at this time, ALLUXTM can be used for one day. The backup battery is
used to supplement the internal power supply. It cannot charge the internal battery.
It is recommended to charge ALLUXTM every day depending on the amount of
activity of the user. (For the charging procedures, see 8. “Charging procedures.”)
The internal power supply has three modes: normal mode (where there are 3 or more
hours of battery life), a mode in which less than three hours of battery life remain, and
a mode in which ALLUXTM cannot be used without charging. If the internal power
supply is exhausted the ALLUXTM cannot be used without charging, the user cannot
use the ALLUXTM even if the backup battery is connected. In the mode in which the
battery is exhausted, there will be a high yielding resistance or a free resistance to the
flexion motion based on choice during adjustment. Please consult your prosthetist.
7States of ALLUXTM
■If the vibration request for safe posture activates during normal
use, the user must be in safe posture.
Flexion/extension resistance may suddenly change, leading to a fall.
■If the vibration does not activate when the charger is disconnected,
discontinue use, and contact your prosthetist.
The vibrator may be defective. Cautions and warnings cannot be given.
Flexion/extension resistance may suddenly change, leading to a fall.
WARNING
■Constant use of the backup battery is not recommended.
Could hasten battery degradation.
* After using the backup battery, charge the internal power supply and
backup battery.
* The operational duration time may vary due to the temperature,
deterioration, or walking conditions.
NOTICE
■Charge the battery every day regardless of the usage of ALLUXTM.
Even when not walking the sensors will be on and draining the battery.
Please exercise caution as the status may differ before and after charging.
■Do not routinely exhaust the battery.
The vibration notification will not unavailable, flexion/extension
resistance may suddenly change, leading to a fall.
■
When the knee joint is heated, do not touch any metallic part of its body.
Could result in burns.
■When the vibration for warning about battery exhaustion
activates, refrain from using ALLUXTM, and charge the battery.
Normal walking will be impossible if the battery runs out during use.
■
When ALLUX
TM
is used in a low-temperature environment, the flexion and
extension resistances may increase. Check the resistances prior to use.
Normal walking will not be supported, possibly resulting in a fall.
■When ALLUXTM is used at a high temperature, the flexion and extension
resistances decrease. Use it carefully when walking on stairs or a slope.
May not support the weight, possibly resulting in a fall.
CAUTION
6
Remote controller Maintenance
11 ALLUXTM User’s Guide

7
States of ALLUXTM
6Remote controller Maintenance
6.1 How to change batteries
When the battery power is depleted, exchange the AAA batteries as below. Please
make sure to change the batteries at least once a year.
6.2 How to attach strap
You can attach a strap to carry the remote controller with you. To attach a strap to
the remote controller, please follow the steps below.
7.1 States of ALLUXTM
ALLUXTM has charging mode, backup battery connecting mode, high-temperature mode,
battery empty mode. When the mode is changed, the vibration will notice the user about
the mode change and you can test the vibration patterns while adjusting the mode.
The internal power supply of ALLUXTM was designed to last for 4 days and the
number of steps taken by the prosthesis is 5000/day. When the remaining battery
time is less than 3 hours, an alert will be given by vibration. If the backup battery is
connected at this time, ALLUXTM can be used for one day. The backup battery is
used to supplement the internal power supply. It cannot charge the internal battery.
It is recommended to charge ALLUXTM every day depending on the amount of
activity of the user. (For the charging procedures, see 8. “Charging procedures.”)
The internal power supply has three modes: normal mode (where there are 3 or more
hours of battery life), a mode in which less than three hours of battery life remain, and
a mode in which ALLUXTM cannot be used without charging. If the internal power
supply is exhausted the ALLUXTM cannot be used without charging, the user cannot
use the ALLUXTM even if the backup battery is connected. In the mode in which the
battery is exhausted, there will be a high yielding resistance or a free resistance to the
flexion motion based on choice during adjustment. Please consult your prosthetist.
7States of ALLUXTM
■If the vibration request for safe posture activates during normal
use, the user must be in safe posture.
Flexion/extension resistance may suddenly change, leading to a fall.
■If the vibration does not activate when the charger is disconnected,
discontinue use, and contact your prosthetist.
The vibrator may be defective. Cautions and warnings cannot be given.
Flexion/extension resistance may suddenly change, leading to a fall.
WARNING
■Constant use of the backup battery is not recommended.
Could hasten battery degradation.
* After using the backup battery, charge the internal power supply and
backup battery.
* The operational duration time may vary due to the temperature,
deterioration, or walking conditions.
NOTICE
■Charge the battery every day regardless of the usage of ALLUXTM.
Even when not walking the sensors will be on and draining the battery.
Please exercise caution as the status may differ before and after charging.
■Do not routinely exhaust the battery.
The vibration notification will not unavailable, flexion/extension
resistance may suddenly change, leading to a fall.
■
When the knee joint is heated, do not touch any metallic part of its body.
Could result in burns.
■When the vibration for warning about battery exhaustion
activates, refrain from using ALLUXTM, and charge the battery.
Normal walking will be impossible if the battery runs out during use.
■
When ALLUX
TM
is used in a low-temperature environment, the flexion and
extension resistances may increase. Check the resistances prior to use.
Normal walking will not be supported, possibly resulting in a fall.
■When ALLUXTM is used at a high temperature, the flexion and extension
resistances decrease. Use it carefully when walking on stairs or a slope.
May not support the weight, possibly resulting in a fall.
CAUTION
6
Remote controller Maintenance
12
ALLUXTM User’s Guide

7
States of ALLUXTM
7.2 Normal use state
7States of ALLUXTM
7States of ALLUXTM
Charging port cap
NE-CC01
Power OFF cap
NE-CC02
7.2.3 Use of backup battery
When the internal battery capacity allows for less than 3 hours of walking, the warning
vibration will be activated. When the battery is exhausted, the control of ALLUXTM will
be stopped. Connecting the backup battery (NE-SB01) before the internal battery runs
out enables the user to use ALLUXTM continuously for one day.
7.2.1 When charger or power OFF cap is disconnected
When the charger (NE-BC01) or the power OFF cap (NE-CC02) is disconnected,
ALLUXTM will enter the normal usage condition, and the vibration will activate to
indicate the residual capacity of the internal power supply of ALLUXTM. After removing
the charger and power OFF connector, connect the charging port cap (NE-CC01).
●Disconnect the charger or the power OFF cap. When the vibration does not sound as
below, connect the charger or the power OFF cap and disconnect it again.
7.2.2 When power is turned off for charging
The power supply turns off when the charger or power off cap are connected.
●Connect the charger
■Do not walk with the power OFF cap (NE-CC02) connected. Walking
control ceases and thus if you attempt to use the unit while
connected it could impair the walking process and result in a fall.
WARNING
●Remove the Charging port cap.
●Fit the backup battery case (NE-SC01) containing the backup battery on the body of
ALLUXTM or the lower leg side of the armoring, such as the foam cover, and secure it
with the Velcro tape.
●Connect the backup battery to ALLUXTM.
* ALLUXTM will enter the normal mode stated in 7.2.1, and the vibration for
confirmation of backup battery capacity will sound.
■Connect the backup battery in a state where the safe posture can
be ensured.
Flexion/extension resistance may suddenly change, leading to a fall.
■Do not secure the backup battery case on the thigh side (above the
knee joint).
The cable may be caught between knee joint parts or damaged
during flexing action, and an excessive load may be applied to the
connector, thereby disconnecting the cable.
■Secure the backup battery case on a side of ALLUXTM body(Frame).
The socket and backup battery may get into contact at the
maximum
flexion angle, and the backup battery may be damaged.
■Do not insert or remove the backup battery while walking as it may
lead to a fall.
* If the cable is disconnected or the battery is damaged during
walking, the user cannot walk normally and may fall.
WARNING
■ After disconnecting the charger, connect the charging port cap. (NE-CC01).
If the cap is not used and the connector terminal comes into contact
with water or another liquid, ALLUXTM may malfunction and enter the
charge mode, and you cannot walk and may be stranded in a
dangerous place.
WARNING
Attach backup battery and
the cable carefully
so as not to get it caught
when the knee joint is flexed.
：3hours or more0.25sec×8times
0.5sec×8times ：Less than 3hours
：No more walk0.75sec8times＋(4sec)
2sec
●Connect the Charging port cap.
：3hours or more0.25sec×8times
0.5sec×8times ：Less than 3hours
0.5sec×8times
：No more walk0.75sec8times＋(4sec)
* The backup battery must be charged.
7
States of ALLUXTM
13 ALLUXTM User’s Guide