Nabtesco ALLUX NE-Z41 User manual

1ALLUXTM User’s Guide
User’s Guide
Product Type : NE－Z41，NE－Z41SH
Document Number ： 81-SS00126E (Ver4)
Date of issue ： 2021-11-01
Related prosthetist IFU: 81-SS00125E(Ver4)
Language: English
TM
CAUTION
Carefully read the User’s Guide prior to use.
Keep this User’s Guide for future reference.

iALLUXTM User’s Guide i
Thank you for purchasing Nabtesco ALLUXTM.
ALLUXTM is a microprocessor 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 ALLUX™.
This document describes matters concerning typical usage such as fitting and walking,
maintenance, trouble shooting and cautionary notes that anyone utilizing ALLUX™
needs to know.
Introduction
Introduction

ii
ALLUXTM User’s Guide
Only the persons who have received ALLUXTM license seminar are allowed to assemble and adjust it.
If necessary, inquire your ALLUXTM certified prosthetist.
ALLUX™ was designed and is manufactured for use as a prosthetick nee 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.
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.
Nabtesco Corporation (hereinafter, referred to as Nabtesco) cannot foresee all of potential residual
risks of ALLUXTM 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.
If you have a serious incident related to ALLUX, please report it to your prosthetist.
Before handling ALLUXTM, thoroughly read this document, and sufficiently understand the contents.
Strictly observe the safety precautions stated in the document.
WARNING
Important Information
Purpose of ALLUXTM
Cautions for handling ALLUXTM safely
Read this document thoroughly
Qualification of assemblers and adjusters
Important Information

iii ALLUXTM User’s Guide iii
This document is intended for the prosthetic users.
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.
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.
The information on this manual is subject to change without prior notice for product
improvement.
● Android is a registered trademark of Google Inc. in the United States and other countries.
● IOS is a trademark or registered trademark of Cisco in the United States and other countries
and is used under license.
● The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc.
and any use of such marks by Nabtesco Corporation is under license.
● QR Code is a registered trademark of Denso Wave Incorporated.
● All other company names and product names are trademarks or registered trademarks of
their respective companies.
About This Document
Copyright
When this document is lost or damaged
About trademarks
Information
Target of this document
About This Document

iv
ALLUXTM User’s Guide
Structure of This Document
This document consists of the following chapters.
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 Modes
by RemoteControl App
How to use the Remote Control App
Explanation of Selective modes by Remote Control App
6. States of ALLUXTM Explanation of states of ALLUXTM and vibration alert patterns
7. Charging Procedure Charging procedure for ALLUXTM
Charging the backup battery pac
8. Maintenance Parts Explanation of service parts
9. Troubleshooting Methods for confirming to improve feeling
10. Disposal Explanation about method of disposal of ALLUXTM
11. Periodic inspection Explanation about periodic inspection and warranty period
12. Warranty Explanation about warranty
13. Symbols Used Explanation about symbols of labels
Structure of This Document

vALLUXTM User’s Guide
Table of Contents
Table of Contents
Introduction............................................................................................................................................................................................................... i
Important Information .......................................................................................................................................................................................... ii
About This Document......................................................................................................................................................................................... iii
Structure of This Document............................................................................................................................................................................ iv
Table of Contents ................................................................................................................................................................................................. v
1 Safety Precautions
󲹾󲹻󲹾󲹭 󲺑󲺲󳞛󲺻󲺶󲻁󲺶󲺼󲺻󲹭󲺼󲺳󲹭󲻀󲻆󲺺󲺯󲺼󲺹󲻀.............................................................................................................................................................................. 1
1.2 Warning ........................................................................................................................................................................................................ 1
1.3 Caution ........................................................................................................................................................................................................ 2
1.4 Notice........................................................................................................................................................................................................... 2
2 Product Overview
2.1 Overview of ALLUXTM.............................................................................................................................................................................. 3
2.2 Basic structure .......................................................................................................................................................................................... 3
󲹿󲹻󲺀󲹭󲺐󲺲󲺿󲻁󲺶󳞛󲺰󲺮󲻁󲺶󲺼󲺻󲹭󲺼󲺳󲹭󲺖󲺻󲻁󲺲󲺿󲺻󲺮󲻁󲺶󲺼󲺻󲺮󲺹󲹭󲺠󲻁󲺮󲺻󲺱󲺮󲺿󲺱............................................................................................................................................. 4
󲹿󲹻󲺁󲹭󲺠󲺽󲺲󲺰󲺶󳞛󲺰󲺮󲻁󲺶󲺼󲺻󲻀.............................................................................................................................................................................................. 5
3 Before Use
3.1 Parts list........................................................................................................................................................................................................ 6
4 Safe Posture
4.1 Safe posture and condition ready for communication............................................................................................................... 7
5 Selective Modes by Remote Control App
5.1 ALLUXTM operational modes................................................................................................................................................................. 8
5.2 Remote Control App ................................................................................................................................................................................ 8
5.3 Operation with the Remote Control App ........................................................................................................................................ 9
5.4 Normal Mode .............................................................................................................................................................................................10
5.4.1 Overview ...................................................................................................................................................................................................................... 10
5.4.2 Yield Function ............................................................................................................................................................................................................ 10
5.4.3 Walking speed auto-adjust function ................................................................................................................................................................. 10
5.4.4 Seated position.......................................................................................................................................................................................................... 10
5.4.5 Safety lock .................................................................................................................................................................................................................. 10
5.4.6 Bicycle .......................................................................................................................................................................................................................... 11
5.5 Flexion angle limit mode .......................................................................................................................................................................11
󲺂󲹻󲺃󲹭󲺣󲺮󲺿󲺶󲺮󲺯󲺹󲺲󲹭󲻀󲺲󲺹󲺲󲺰󲻁󲺶󲻃󲺲󲹭󳞜󲺲󲻅󲺶󲺼󲺻󲹭󲺹󲺼󲺰󲺸󲹭󲺺󲺼󲺱󲺲 ...............................................................................................................................................11
5.7 Full extension lock mode......................................................................................................................................................................11
5.8 Free swing mode...................................................................................................................................................................................... 11

vi
ALLUXTM User’s Guide
Table of Contents
Table of Contents
6 States of ALLUXTM
6.1 States of ALLUXTM .................................................................................................................................................................................12
6.2 Normal use state.....................................................................................................................................................................................13
6.2.1 When battery charger or power OFF cap is disconnected...................................................................................................................... 13
6.2.2 When power is turned off for charging ............................................................................................................................................................. 13
6.2.3 Use of backup battery pac .................................................................................................................................................................................... 14
6.2.4 Battery exhaustion (zero battery)...................................................................................................................................................................... 16
6.2.5 In high-temperature state...................................................................................................................................................................................... 17
6.3 In case of malfunction...........................................................................................................................................................................18
6.4 Vibration alert pattern chart .............................................................................................................................................................. 19
7 Charging Procedures
7.1 Charging ALLUXTM...................................................................................................................................................................................................................................................................................................................... 21
󲺄󲹻󲹾󲹻󲹾󲹭󲺠󲺽󲺲󲺰󲺶󳞛󲺰󲺮󲻁󲺶󲺼󲺻󲻀󲹭󲺳󲺼󲺿󲹭󲺯󲺮󲻁󲻁󲺲󲺿󲻆󲹭󲺰󲺵󲺮󲺿󲺴󲺲󲺿󲹭󲺮󲺻󲺱󲹭󲺎󲺐󲹭󲺮󲺱󲺮󲺽󲻁󲺲󲺿 .................................................................................................................................... 21
7.1.2 Charging procedure................................................................................................................................................................................................... 22
7.1.3 Charging the backup battery pac........................................................................................................................................................................ 23
7.1.4 Indication by LED lamp on battery charger.................................................................................................................................................... 24
7.1.5 Use of extension cable............................................................................................................................................................................................ 24
8 Maintenance Parts
8.1 List of maintenance parts.................................................................................................................................................................... 25
9 Troubleshooting
9.1 Troubleshooting list................................................................................................................................................................................26
10 Disposal
11 Periodic Inspection
11.1 Periodic Inspection...............................................................................................................................................................................29
11.2 How to care.............................................................................................................................................................................................29
12 Warranty
12.1 Warranty ...................................................................................................................................................................................................30
12.2 Warranty periods of designated devices .....................................................................................................................................31
12.3 Repair.........................................................................................................................................................................................................32
13 Symbols Used
13.1 UDI label (Packing box) ...................................................................................................................................................................... 33
13.2 Serial number label (Charging port)...............................................................................................................................................33
󲹾󲺀󲹻󲺀󲹭󲺐󲺲󲺿󲻁󲺶󳞛󲺰󲺮󲻁󲺶󲺼󲺻󲹭󲺺󲺮󲺿󲺸󲹭󲺹󲺮󲺯󲺲󲺹.......................................................................................................................................................................33
13.4 Battery charger label (Battery charger)......................................................................................................................................33
13.5 AC adapter label (AC adapter)........................................................................................................................................................ 34
󲹾󲺀󲹻󲺃󲹭󲺏󲺮󲺰󲺸󲻂󲺽󲹭󲺯󲺮󲻁󲻁󲺲󲺿󲻆󲹭󲺹󲺮󲺯󲺲󲺹󳞥󲹭󲺏󲺮󲺰󲺸󲻂󲺽󲹭󲺯󲺮󲻁󲻁󲺲󲺿󲻆󲹭󲺽󲺮󲺰󳞦.............................................................................................................................35
󲹾󲺀󲹻󲺄󲹭󲺏󲺮󲺰󲺸󲻂󲺽󲹭󲺯󲺮󲻁󲻁󲺲󲺿󲻆󲹭󲺵󲺼󲺹󲺱󲺲󲺿󲹭󲺹󲺮󲺯󲺲󲺹󳞥󲹭󲺏󲺮󲺰󲺸󲻂󲺽󲹭󲺯󲺮󲻁󲻁󲺲󲺿󲻆󲹭󲺵󲺼󲺹󲺱󲺲󲺿󳞦..........................................................................................................35

1ALLUXTM User’s Guide
WARNING
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.
NOTICE
Strictly observe the following instructions to use the product safely.
As protective measure above-mentioned, the instructions to be observed are classified
and explained by using the following pictograms.
Safety Precautions
1
1
Safety Precautions
1.1 Definition of symbols
1.2 Warning
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.
Indicates actions that you must not do when handling the
product.
Indicates actions that you must do based on instructions
when handling the product.
CONTRAINDICATIONS
Damage only.
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 carry heavy items at all time.
Do not perform violent operations when carrying a heavy item.
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 ALLUXTM, do not put your hand behind the knee joint.
When extending ALLUXTM, do not touch the knee.
This can cause injury from your hand being caught in the knee joint.
Be careful so that the form cover or stocking gets caught in the four-bar
joint section or other parts.
It may cause an operational malfunction.
WARNING
CAUTION

2
ALLUXTM User’s Guide
Safety Precautions
CAUTION
Strictly observe the following instructions to use the product safely.
Strictly observe the following instructions.
NOTICE
Safety Precautions
1
1
1.3 Caution
1.4 Notice
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.
Do not leave the unit unused for an extended period of time.
Could cause performance problems or failures do to the battery
remaining in completely discharged state, the hydraulic fuild or bearing grease
deteriorating, and/or the knee axis becoming set in a fixed position.
Ensure that no solid particles or foreign objects can penetrate into the product. The parts
could be damaged or broken, thus resulting in a fall.
Do not immerse the product in liquids, such as water.
ALLUXTM is not resistant to penetration from water jets, steam, or submersion.
If it gets wet, wipe ALLUXTM firmly with a lint-free cloth and let it fully air dry in the shade.
Do not contact liquids such as salt water, chlorinated water, soapy water, gel soap, body
fluids and exudates.
If ALLUXTM comes in contact with above liquid, wipe it with a lint-free cloth moistened
with fresh water.
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 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 use the product in a low-pressure area such as a high mountain.
Be sure to hand over the attached User’s Guide to the user and explain the
precautions for use.
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 battery charger. Abnormal
voltage use, could result in a malfunction.
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.
Never attempt to disassemble or modify the product.
The parts could be damaged or broken, thus resulting in a fall.
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.

3ALLUXTM User’s Guide
Pyramid or threaded type
Link part
Inner battery
Charging connector
Microproccessor
Hydraulic cylinder
Frame
Pyramid adaptor
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 ALLUXTM 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).
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.
2.2 Basic structure
2.1 Overview of ALLUXTM
Product Overview
2
Product Overview
2

4
ALLUXTM User’s Guide
Structural durability
K Level(MOB)
EMC Information
Declaration of Conformity
CAUTION
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.
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.
ALLUXTM belongs to Group 1 and Class A equipment in accordance with IEC/EN60601-1-2.
ALLUXTM requires special precautions regarding EMC (Electromagnetic Compatibility) and
need to be installed, put into service and used according to the following information.
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 ALLUXTM.
Do not use ALLUXTM adjacent to other equipment. Portable and mobile RF
communications equipment can affect ALLUXTM. If adjacent use is necessary,
take care.
Please carefully read this instruction manual to avoid the risk of ignition or
electric shock.
Nabtesco Corporation, hereby declare that following Class I medical device complies
with the essential health and safety requirements of the REGULATION (EU) 2017/745
OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on medical
devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation
(EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
*）
Body mass limit not to be exceeded. For specific conditions and limitations of
use see manufacturer’s written instructions on intended use.
ISO10328-P6-125kg*）
2.3 Certification of International Standard
Product Overview
2
Product Overview
2

5ALLUXTM User’s Guide
Product Overview
Type： NE-Z41 (pyramid), NE-Z41SH (threaded)
Application range & Weight limit:
～ K3(MOB3):125kg(275 lb)
K4(MOB4):100kg(220 lb)
Weight: 1510g(NE-Z41)/1520g(NE-Z41SH)
Maximum flexion angle: 180º
Water resistance: IP44
Internal power supply:
Lithium ion battery
Communication distance: Within 5 m
Usage temperature:
-10℃/+14℉ ～ +40℃/+104℉
CAUTION
NOTICE
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.
Do not give the product a strong impact, such as hitting the front cover to
the product.
This could deteriorate its water-proof performance.
Do not immerse the product in water.
Do not wash the product with a high temperature or pressure.
This could allow water invasion and damage the product.
If the product is wetted, wipe the moisture out.
Do not allow saltwater such as seawater to attach to the product.
If liquid other than water attaches, wash the product. Do not use any
detergent.
Such liquid could cause rust or corrosion.
The maximum flexion angle may be less than 180° depending on the shape
of the socket and the presence of a resin stopper.
Dimensions ： D
B
A
F
※ 1 inch = 25.4mm
※ The above specifications are subject to change without prior notice for
product improvement.
NE-Z41 NE-Z41SH
A 295mm 287mm
B 30mm 22mm
C 268mm 266mm
D 15mm 15mm
E 21mm 21mm
F 76mm 68mm
G 16.5mm 14mm
2.4 Specifications
Product Overview
2
2
G
E
C

6
ALLUXTM User’s Guide
Before Use
3
3.1 Parts list
The package of ALLUXTM contains the following parts. Confirm whether everything is included.
※ For screw heads, 81-SS0062 Knee Release Adapter Instruction Manual will be added.
※ The shape of the plug depends on the form ordered.
※ Backup battery pac may not be included depending on the form ordered.
【Main body and accessories】
【Designated devices】
ALLUXTM
NE-Z41
Backup battery holder
NE-SC01
Instruction Manual
81-SS00125E User’s Guide 81-SS00126E This Document
Bluetooth password and
unit number
81-SS00133
Information as to Periodic
Inspection
81-SS00135
Charging port cap
NE-CC01
Power OFF cap
NE-CC02
Backup battery pac NE-SB01 Extension cable
NE-CL02
Battery charger
NE-BC01
AC adapter
NE-AD01
Plug adapter(UL)
NE-PAXX
Backup battery charging
cable
NE-CL01
Do not use non-designated peripheral devices.
That might cause a crash of ALLUXTM.
NOTICE
Before Use
3
ProductType：NE−Z41，NE−Z41SH
DocumentNumber：81-SS00126E(Ver4)
Dateofissue：2021-07-01
RelatedprosthetistIFU:81-SS00125E(Ver4)
Language:English
■CarefullyreadtheUserʼsGuidepriortouse.
■KeepthisUserʼsGuideforfuturereference.
UserʼsGuide
CAUTION
TM

7ALLUXTM User’s Guide
Safe Posture
4
Safe Posture
4
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 Control App or communicating with the Remote Control App. Be sure to understand
the following safe postures before using ALLUXTM.
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.
【Safe posture】
CAUTION
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.
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
battery charger or power OFF cap from ALLUXTM. Once ALLUXTM communication is established,
this state lasts until communication is disconnected.
When you board an airplane or other such vehicles and need to turn off the wireless function of
ALLUXTM, you can use the Remote Control App to turn it off. To reactivate the wireless function again
after that state, follow the procedure provided below. To reactivate the wireless function again after that
state, follow the procedure provided below.
①Remove the battery charger or the power source OFF cap from ALLUXTM.
② In the case, loads are applied intermittently on the toe or heel four times (this operation can be
changed on the smartphone).
A vibration will occur to tell the reactivation of the wireless function when operation
② is performed.
Note that this vibration occurs if operation ② is performed even when the wireless function is active.
120
Sec
2sec ：reactivates the wireless function.
120
Sec
120
sec
120
sec
Do this
four
times.
Do this
four
times.

8
ALLUXTM User’s Guide
Selective Modes by Remote Control App
5
5.1 ALLUXTM operational modes
5.2 Remote Control App
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
Install the Remote Control App of smartphone.
● ALLUXTM supports the following operating systems (OS):
Android ：7 or later
(There is no guarantee that it will work on every Android device.)
iOS ：13 or later
● The installation and adjustment methods vary depend on the OS.
Download the manual corresponding to the OS from the website below and
follow the instructions.
Website for downloading the Remote Control App Manual:
https://allux.info/ne-z41/manual_u.html
Use the Remote Control App to change the operational modes. The optional buttons on the Remote
Control App can be customized as appropriate. Please consult your prosthetist.
Precautions on Bluetooth
Radio waves emitted by a Bluetooth device may affect the operation of electronic
devices and other devices.
Turn off Bluetooth devices when near priority seats in trains, in areas where
flammable gas is generated such as in airplanes, near automatic doors and fire
alarm devices, as it may cause an accident.
We do not take any responsibility for the leakage of information when using
Bluetooth technology.
This product does not guarantee wireless connection with all Bluetooth devices.
The Bluetooth device to be connected must comply with the Bluetooth standard
specified by Bluetooth SIG and must have obtained at least a certification.
In addition, even if the device to be connected complies with the Bluetooth
standard, phenomena such as inability to connect or different display/operation
may occur, depending on the characteristics and specifications of the device.
Do not disassemble or modify this product as the wireless functionality of this
product has been certified to meet technical standards.
Selective Modes by Remote Control App
5

9ALLUXTM User’s Guide
Selective Modes by Remote Control App
5
5.3 Operation with the Remote Control App
Operational Modes
①Normal mode: normal walking --- button 1 or optional button
②Flexion angle limit mode: lock ALLUXTM at a designated angle --- optional button
③ Variable selective flexion lock mode: lock ALLUXTM at the angle designated by the Remote Control
App --- optional button
④Full extension lock mode: lock ALLUXTM at the fully extended position --- optional button
⑤Free swing mode: maintain the least resistance against flexion and extension --- optional button
The operational mode can be selected with the Remote Control App of smartphone, etc.
To change modes, tap the button on the Remote Control App within 120 seconds of bending
and stretching your knee or removing your body weight and then applying it while standing
in safe posture.
Press the ‘1’ button on the Remote Control App to return to normal mode.
If using a smartphone, be careful to prevent buttons etc from incorrect
operation..
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 incorrect operation of the
Remote Control App has occurred.
Please do not use the Remote Control App anywhere radio waves are prohibited,
for example aircraft etc.
Connecting and disconnecting the battery charger and power off cap will result
in ALLUX™ returning to the normal mode set using the ‘1’ button on the Remote
Control App.
Please exercise caution as the status may differ before and after charging.
●Assume safe posture. (See 4. Safe posture)
●Tap buttons 1-5 on the Remote Control App.
●Then a pop-up will appear. Select ″OK″.
vibration will sound for 2 seconds.
●The selected mode is applied.
After a mode change, move ALLUXTM to check the behavior. If the mode has not
been changed to the intended one due to a wrong button operation, an accident
such as a fall may occur.
WARNING
NOTICE
CAUTION
Selective Modes by Remote Control App
5

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ALLUXTM User’s Guide
Selective Modes by Remote Control App
5
5.4 Normal Mode
5.4.1 Overview
The normal mode is adjusted for normal walking. Judging various walking situations and normal motions
with the sensor, ALLUXTM automatically adjusts the flexion or extension resistance.
5.4.2 Yield Function
In the following situations, ALLUXTM yields, increasing flexion resistance and allowing knees to bend slowly.
5.4.3 Walking speed auto-adjust function
ALLUXTM automatically adjusts the flexion and extension resistance according to walking speed.
5.4.4 Seated position
When in a seated position, ALLUXTM maintains no resistance in flexion or extension.
5.4.5 Safety lock
When under a burden and knees are bent continually for a few seconds, ALLUXTM locks the
flexion resistance at a certain angle. (This function can be turned off or the sensitivity can
be adjusted.)
Standing Sitting down Standing up Going down steps Going downhill
WARNING
CAUTION
CAUTION
CAUTION
Hold onto the handrail while getting down the stairs.
An intended behavior of the product may cause a fall.
Check the setting in a safe place,
such as in between parallel bars.
An inappropriate adjustment may
produce bad timing.
When standing up from a seated position, put your weight
on the side with the prosthesis.
A free state continues, which may cause a knee to bend.
During a safety lock,
keep putting weight
on ALLUXTM. The lock
may be released, causing
ALLUXTM to bend.
Selective Modes by Remote Control App
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11 ALLUXTM User’s Guide
Selective Modes by Remote Control App
Selective Modes by Remote Control App
5
5
5.5 Flexion angle limit mode
5.6 Variable selective flexion lock mode
5.7 Full extension lock mode 5.8 Free swing mode
5.4.6 Bicycle
When riding a bicycle with ALLUXTM, lower the Stance Resistance value to a low setting to allow
it to easily flex.
If riding a bicycle is more comfortable in “Free mode”, make sure the user is
able to stand using their sound side while in the riding position. Make sure
they are aware that if the prosthesis is used to stand, while stopping there
will be no microprocessor stumble recovery or highresistance to prevent
the knee from bucking and the user may fall.
In flexion angle limit mode, flexion resistance is locked at a designated angle while extension
resistance remains free.
ALLUXTM remembers the angle at which variable selective flexion lock mode is turned on.
Flexion resistance is locked when it reaches that angle while extension resistance remains free.
Knees are locked in a fully extended state.
To change modes using the Remote
Control App once locked, put your weight
on ALLUXTM and then remove it.
In free swing mode, ALLUXTM is kept
free.
CAUTION
NOTICE
Bend ALLUXTM to the lock angle
swiftly; do not stop in the middle.
ALLUXTM may be damaged.
NOTICE
Bend ALLUXTM to the lock angle
swiftly; do not stop in the middle.
ALLUXTM may be damaged.
0 °～
60°
( )
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ALLUXTM User’s Guide
States of ALLUXTM
6
States of ALLUXTM
6
6.1 States of ALLUXTM
ALLUXTM has charging mode, backup battery pac 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 pac is connected at this
time, ALLUXTM can be used for one day. The backup battery pac 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 7. “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 ALLUXTM cannot be used without
charging, the user cannot use ALLUXTM even if the backup battery pac 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.
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 battery 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.
Constant use of the backup battery pac is not recommended.
Could hasten battery degradation.
* After using the backup battery pac, charge the internal power supply and
backup battery pac.
* The operational duration time may vary due to the temperature,
deterioration, or walking conditions.
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 ALLUXTM 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 ALLUXTM 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.
WARNING
CAUTION
NOTICE

13 ALLUXTM User’s Guide
States of ALLUXTM
States of ALLUXTM
6
6
6.2 Normal use state
6.2.1 When battery charger or power OFF cap is disconnected
When the battery 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 battery
charger and power OFF connector, connect the charging port cap (NE-CC01).
● Disconnect the battery charger or the power OFF cap. When the vibration does not sound
as below, connect the battery charger or the power OFF cap and disconnect it again.
6.2.2 When power is turned off for charging
The power supply turns off when the battery charger or power off cap are connected.
●Connect the battery charger
●Connect the Charging port cap.
0.25sec×8times :3hours or more
0.5sec×8times :Less than 3hours
2sec
0.75sec8times+(4sec) :No more walk
After disconnecting the battery 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.
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
Charging port cap
NE-CC01
Power OFF cap
NE-CC02
WARNING