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ALLUX

User’s Guide

Only the persons who have received ALLUX

license seminar are allowed to assemble and adjust it.

If necessary, inquire your ALLUX

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 ALLUX

for any other purposes. For hip

prostheses, it is recommended to use a torsion adapter to prevent application of large torsion
to ALLUX

For the specifications for ALLUX

, see 2.Product Overview.

Do not use ALLUX

outside of the specification range. Do not modify the

main body or parts.
Doing so can cause injury or damage ALLUX

Nabtesco Corporation (hereinafter, referred to as Nabtesco) cannot foresee all of potential residual
risks of ALLUX

and risks resulting from human errors and usage environment.

Although there are a lot of instructions and prohibitions for handling ALLUX

(assembling,

adjusting and maintaining the prosthesis), all these matters cannot be described in this document
or on the warning labels on the body of ALLUX

Therefore, when handling ALLUX

, 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 ALLUX

are described below.

If you have a serious incident related to ALLUX, please report it to your prosthetist.

Before handling ALLUX

, thoroughly read this document, and sufficiently understand the contents.

Strictly observe the safety precautions stated in the document.

WARNING

Important Information

Purpose of ALLUX

Cautions for handling ALLUX

safely

Read this document thoroughly

Qualification of assemblers and adjusters

Important Information

Содержание ALLUX NE-Z41

Страница 1: ...duct 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 ...

Страница 2: ...gh 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 Introductio...

Страница 3: ...isks 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...

Страница 4: ...ithout 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 trade...

Страница 5: ...e 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 ...

Страница 6: ...ndard 4 2 4 Specifications 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 1...

Страница 7: ... 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 device...

Страница 8: ...e 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 damage...

Страница 9: ...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 hei...

Страница 10: ...n 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 ...

Страница 11: ...mation 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 ...

Страница 12: ... 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 de...

Страница 13: ...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 ALLUX...

Страница 14: ...ds 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 reactiv...

Страница 15: ...our 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 in...

Страница 16: ...f 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 pr...

Страница 17: ...on 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...

Страница 18: ...roprocessor 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 f...

Страница 19: ... 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 backu...

Страница 20: ... 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 th...

Страница 21: ...hours or more 0 5sec 8times Less than 3hours 0 75sec8times 4sec No more walk The backup battery pac must be charged Connect the backup battery pac 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 holder on the thigh side above ALLUXTM The cable may be caught between knee joint parts or damaged durin...

Страница 22: ...if significantly scratched or deformed The power supply ceasing due to poor contact etc the parts Could be damaged or broken thus resulting in a fall Do not drop from a height Do not allow strong shock Could result in a malfunction Do not use if liquid leaks or an abnormal odor is exuded Could lead to failure of the main ALLUXTM unit Do not allow babies children or animals to touch lick or put in ...

Страница 23: ...the user is walking and may result in a fall NE SB01 6 2 4 Battery exhaustion zero battery When the internal power supply has exhausted and ALLUXTM cannot be used the warning about battery exhaustion will be given by vibration Then the vibration for request for safe posture will be given When the user takes the safe posture the walking control will be stopped and ALLUXTM will be locked yielding re...

Страница 24: ... a high temperature When the temperature of ALLUXTM rises the vibration for warning about increasing temperature will sound at first In this state the user can walk If ALLUXTM is used continuously the vibration for alerting the user to stop using due to high temperature will be given When the user takes the safe posture ALLUXTM will be locked yielding resistance with high flexion resistance After ...

Страница 25: ... has abnormally increased 4sec 4times 10sec Take the safe posture ALLUXTM will be locked in the ﬂexed state at a high yielding resistance When ALLUXTM cools down 0 5 3times 15times Request for safe posture ALLUXTM will be restored to the normal state even if the user is not in the safe posture after the completion of vibration for 1 minute The vibration for confirmation of battery capacity will so...

Страница 26: ...l walking can still continue 4sec 4times 10sec When the main ALLUX unit has become abnormally hot Normal walking is not currently supported by ALLUX and will not return until the temperature has dropped Please wait until normal status has been achieved as indicated by vibration pattern 0 25sec 50times 5sec When the main ALLUX unit has been malfunctioned The status of ALLUX is abnormal and normal w...

Страница 27: ... low battery zero battery high temperature malfunction malfunction detection 9 The detection of any abnormality will result in the abnormality status No 1 12 correspond to numbers in the vibration alert pattern chart 6 4 detect temperature detect temperature 6 4 6 connect the battery charger 1 low battery Safety lock disconnect the battery charger 2 3 reactivation of wireless function 10 States of...

Страница 28: ...perature of 10 14 or less or 60 140 or more Charge indoors in a temperature range from 0 32 to 40 104 Do not pull the connector cable with a force of 30 N 3 kgf or more Do not charge from a car cigar plug cord After charging do not use without the Charging port cap NE CC01 Do not put any conductive body such as metallic parts to the connector terminal of ALLUXTM Failing to follow the above could c...

Страница 29: ...will be heard To remove the adapter slide it while pressing the center pawls Connect the battery charger and AC adapter Insert the plug adapter of the AC adapter to a commercial power supply For connection to a supply not in the U S A use an attachment plug adaptor of the proper configuration for the power outlet if needed Remove the Charging port cap NE CC01 of ALLUXTM Remove it sliding the conne...

Страница 30: ...ptor may overheat or catch fire Keep children and infants away while the AC adaptor is connected to the commercial power supply There is a risk of electric shock NOTICE NOTICE 7 1 3 Charging the backup battery pac Charge the backup battery pac in the same manner as when charging the main body of ALLUXTM Connect the charging cable for backup battery NE CL01 to the battery charger connector and conn...

Страница 31: ...ot charge owing to a failure ON Completion of charging The battery has been charged fully Flashing Waiting until charging Waiting until the heated battery cools down LED lamp on battery charger Backup battery charging cable NOTICE 7 1 4 Indication by LED lamp on battery charger The LED lamp on the battery charger has four modes When it does not light up recheck the connection referring to 7 1 2 If...

Страница 32: ... List of maintenance parts Do not apply a commonly sold lubricant Such lubricant may impede a smooth bending of ALLUXTM The backup battery pac is a L ithium ion battery Do not discard the battery with general household garbage Thrown away short circuits of the battery may cause ignition and release of fume NOTICE NOTICE Main body of ALLUXTM NE Z41 If the battery life is coming to an end contact to...

Страница 33: ...tlined above Contact your prosthetist Unable to change modes with the Remote Control App Are you pressing the button within 120 seconds of flexing and extending ALLUXTM or removing your body weight and then applying it Flex and extend ALLUXTM or removing your body weight and then applying it assume safe posture and use the Remote Control App See 4 1 Are you in safe posture when operating via the R...

Страница 34: ...fficiently to ALLUXTM When the weight is not applied or ALLUXTM is flexing or extending even slowly the lock does not function Hold ALLUXTM in a sufficiently loaded state In cases other than above Please contact your prosthetist ALLUXTM is locked and jams when you sit down Check that you do not stop flexing ALLUXTM halfway Since the safety lock is effective it is necessary to sit down without stop...

Страница 35: ...r reinforced composite material Aluminum structural parts are inserted in it 2 Knee links Metal Aluminum alloy 3 Knee pad Rubber 4 Stopper rubber Rubber 5 Hydraulic cylinder Metal Body aluminum alloy piston rod titanium alloy o ring rubber 6 Microprocessor control board Electronic component Electronic substrates and component chips comply with the RoHS directive 7 Lead wire Electric wire 8 Battery...

Страница 36: ...rge if they have deteriorated during the periodic inspection within the warranty period When you want to ask us about a periodic inspection contact your prosthetist Ensure that ALLUXTM undergoes periodic inspection after 2 years If it is used without periodic inspection wear and deterioration may be accelerated and the warranty may not cover issues or damages Make sure that no moisture or lint fro...

Страница 37: ...or damage is caused by incorrect use or improper modification or repair When failure or damage is caused by fire earthquake wind flood seawater lightning or any other extraordinary natural phenomenon When failure or damage is caused by use of a device other than those designated by Nabtesco When failure or damage occurs after the warranty period has expired When failure or damage is caused by adju...

Страница 38: ...harger are shown in the following table Charging port cap NE CC01 1 year Power OFF cap NE CC02 1 year Backup battery pac NE SB01 1 year Extension cable NE CL02 1 year Battery charger NE BC01 1 year AC adapter NE AD01 1 year Plug adapter UL NE PAXX 1 year Backup battery charging cable NE CL01 1 year Backup battery holder NE SC01 1 year Warranty 12 Warranty ...

Страница 39: ...tributor 2 Repair of external painting will be performed at the user s expense Ask the Distributor for estimation 3 If ALLUXTM must be repaired after the warranty period has expired the warranty period only for the repaired part will be extended for 6 months 4 ALLUXTM which has been used for 8 years after purchase may be unrepairable Warranty 12 12 Warranty ...

Страница 40: ...017 745 Single patient multiple use Declaration of conformity according to the applicable European directives The EU requires recycling without landfill When disposing of it follow the rules of the local government Body mass limit not to be exceeded See page 4 Declaration of conformity according to the applicable European directives The EU requires recycling without landfill When disposing of it f...

Страница 41: ...rds for Japan Double insulation Compliant with LPS standard DC center plus Tu V Rheinland has certified GS mark Safety standards for Germany Based on RoHS Directive certain hazardous substances are below the standard value Declaration of conformity according to the applicable European directives The EU requires recycling without landfill When disposing of it follow the rules of the local governmen...

Страница 42: ...ty standards Declaration of conformity according to the applicable European directives The EU requires recycling without landfill When disposing of it follow the rules of the local government Indicates the need for the user to consult the instructions for use Lithium ion battery Wash by hand chlorine and oxygen bleach is prohibited Ironing is prohibited Dry cleaning is prohibited Tumble drying is ...

Страница 43: ...MEMO ...

Страница 44: ...tive Products Department 35 Uozakihama machi Higashinada ku KOBE 658 0024 JAPAN Phone 81 78 413 2724 Fax 81 78 413 2725 https welfare nabtesco com Please contact us if you find any page missing or disordered PROTEOR SAS 6 rue de la Redoute 21850 Saint Apollinaire France TEL 33 3 80 78 42 42 FAX 33 3 80 78 42 15 cs proteor com ...

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