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Related Manuals for Nabtesco ALLUX NE-Z41
Summary of Contents for Nabtesco ALLUX NE-Z41
- Page 1 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 CAUTION Carefully read the User’s Guide prior to use. Keep this User’s Guide for future reference. ALLUX User’s Guide...
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Page 2: Introduction
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™... -
Page 3: Important Information
WARNING Cautions for handling ALLUX safely 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... -
Page 4: About This Document
This document is intended for the 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. -
Page 5: Structure Of This Document
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 ALLUX About This Document Notes on this document Structure of This Document Contents of each chapter in this document 1. -
Page 6: 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. Definition.of.symbols ....................................1 1.2 Warning ........................................1 1.3 Caution ........................................2 1.4 Notice ........................................... -
Page 7: Table Of Contents
Table of Contents 6 States of ALLUX 6.1 States of ALLUX ....................................12 6.2 Normal use state ..................................... 13 6.2.1 When battery charger or power OFF cap is disconnected ........................1 3 6.2.2 When power is turned off for charging ................................1 3 6.2.3 Use of backup battery pac .................................... -
Page 8: Safety Precautions
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. Indicates a potentially hazardous situation which, if not WARNING avoided, could result in death or serious injury. -
Page 9: Caution
Safety Precautions 1.3 Caution Strictly observe the following instructions to use the product safely. CAUTION The adjustment of ALLUX must be done by a certified prosthetist of ALLUX handling. Incorrect adjustment could impair walking safety and comfort. Charge the main body of ALLUX before using it. -
Page 10: Product Overview
Product Overview 2.1 Overview of ALLUX ALLUX 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 ALLUX suddenly bending and as an anti-stumbling function for when the toes get stubbed on the ground etc. -
Page 11: Certification.of.international.standard
Declaration of Conformity 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... -
Page 12: Specifications
Product Overview 2.4 Specifications Type ： NE-Z41 (pyramid), NE-Z41SH (threaded) Water resistance: IP44 Application range & Weight limit: Internal power supply: ～ K3(MOB3):125kg(275 lb) Lithium ion battery K4(MOB4):100kg(220 lb) Communication distance: Within 5 m Weight: 1510g(NE-Z41)/1520g(NE-Z41SH) Usage temperature: Maximum flexion angle: 180º -10℃/+14℉... -
Page 13: Before Use
Before Use 3.1 Parts list The package of ALLUX contains the following parts. Confirm whether everything is included. 【Main body and accessories】 ALLUX Backup battery holder NE-Z41 NE-SC01 Instruction Manual User’s Guide 81-SS00126E This Document Userʼs Guide Product Type ： N E −Z41 ， NE −Z41SH Document Number ：... -
Page 14: Safe Posture
Safe Posture 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 ALLUX 【Safe posture】... -
Page 15: Selective Modes By Remote Control App
Selective Modes by Remote Control App 5.1 ALLUX operational modes ALLUX 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 Control App to change the operational modes. The optional buttons on the Remote Control App can be customized as appropriate. -
Page 16: Operation With The Remote Control App
Selective Modes by Remote Control App 5.3 Operation with the Remote Control App 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. -
Page 17: Normal Mode
Selective Modes by Remote Control App 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, ALLUX automatically adjusts the flexion or extension resistance. 5.4.2 Yield Function In the following situations, ALLUX yields, increasing flexion resistance and allowing knees to bend slowly. -
Page 18: Bicycle
Selective Modes by Remote Control App 5.4.6 Bicycle When riding a bicycle with ALLUX , 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. -
Page 19: States Of Allux
States of ALLUX 6.1 States of ALLUX ALLUX 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 ALLUX was designed to last for 4 days and the number of steps taken by the prosthesis is 5000/day. -
Page 20: Normal Use State
States of ALLUX 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, ALLUX will enter the normal usage condition, and the vibration will activate to indicate the residual capacity of the internal power supply of ALLUX . -
Page 21: Use Of Backup Battery Pac
States of ALLUX 6.2.3 Use of backup battery pac 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 ALLUX will be stopped. Connecting the backup battery pac (NE-SB01) before the internal battery runs out enables the user to use ALLUX continuously for one day. - Page 22 States of ALLUX ■Do not use the backup battery pac for any other devices. It may cause damage to the battery or the device. ■Do not use constantly in the normal state. The main battery for internal power supply of ALLUXTM shall not be charged by backup battery.
- Page 23 States of ALLUX 【Specifications for backup battery pac】 ■Service temperature: 0℃/+32℉ to +40℃/+104℉ ■Resistance to ambient temperature: -20℃/-4℉ to +60℃/+140℉ ■Resistance to ambient humidity: 10 to 90%RH ■Battery charger: NE-BC01 ■Applicable device: ALLUX (NE-Z41 or NE-Z41SH) ■Service life: 1 year NE-SB01 6.2.4 Battery exhaustion (zero battery) When the internal power supply has exhausted and ALLUX...
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Page 24: In High-Temperature State
States of ALLUX 0.75 ) ： No more walk times＋ 0.5 * 3 ： Request for safe posture times× times ⇒ ALLUX will be locked even if the user is not in the safe posture after the completion of vibration for 1 minute. ●The user must take the safe posture. -
Page 25: In Case Of Malfunction
States of ALLUX 【When the temperature is increasing】 sec * times with sec interval * Stop walking with the yielding function or take a rest and stay still until ALLUX cools down. 【When the temperature has abnormally increased】 sec * times＋... -
Page 26: Vibration Alert Pattern Chart
States of ALLUX 6.4 Vibration alert pattern chart Vibration alert Alert conditions Meaning When the battery charger or Control of ALLUX™ has been stopped. Power OFF cap is connected When the battery charger or The battery level supports at least 3 hours 0.25 Power OFF cap are disconnected sec ×... - Page 27 States of ALLUX The figure below provides the different types of ALLUX™ status and the transitionary vibration notification patterns. Mode operation Safety lock Restart disconnect the Do this battery charger Do this four times. four times. normal charging reactivation of wireless function detect 6 7 8...
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Page 28: Charging Procedures
Charging Procedures 7.1 Charging ALLUX The internal power supply of ALLUX and backup battery pac shall be charged with the special battery charger (NE-BC01). When using ALLUX , it is recommended to charge it every day as a rule. ■Remove the prosthesis before charging. ■... -
Page 29: Charging Procedure
Charging Procedures 7.1.2 Charging procedure Connect the battery charger （ NE-BC01） and AC adapter (NE-AD01) to charge from an indoor household power supply outlet. Although the charging time depends on the residual battery capacity, the battery will be fully charged after about 3 hours. Four types of plug adapters are available for the AC adapter. -
Page 30: Charging The Backup Battery Pac
Charging Procedures ●The LED lamp on the battery charger will light on in orange. * If the temperature of ALLUX is higher than +40℃/+104℉ just after ALLUX is used, the green LED lamp will flash. ●When charging is completed after a certain time, the LED lamp will turn green. * If ALLUX is left for a long time after the completion of charging and the battery capacity becomes lower than a certain level, the battery will be recharged. -
Page 31: Indication By Led Lamp On Battery Charger
Charging Procedures 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 the LED lamp still does not light up, the battery charger or the AC adapter may be defective. -
Page 32: Maintenance Parts
Maintenance Parts The lifetime of the device is 6 years, depending on the activity level of the patient. The actual useful life is ultimately determined by the prosthetist upon request of the device’s owner. While the device is in use and after the end of the period of use, its functionality and operating condition should be assessed by the prosthetist periodically with a minimum frequency of 2 years. -
Page 33: Troubleshooting
Troubleshooting 9.1 Troubleshooting list Should you encounter any issues in the use of your ALLUX , please check the following list. If you are encountering an issue not listed in the below list, please contact your prosthetist. Issue Check item Solution Your ALLUX wont charge. - Page 34 Troubleshooting Issue Check item Solution Abnormal noise or Check for foreign substances. Please remove any foreign matter and weakness in joints. Are any screws etc. interfering with the ensure that normal movement takes knee joint section? place. Does vibration sound when connected Please contact your prosthetist.
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Page 35: Disposal
When disposing of ALLUX , comply with the rules stipulated in the local community. If you return it to Nabtesco after giving such a notification, we will dispose of it for you. Part name Classification of material... -
Page 36: Periodic Inspection
Periodic Inspection 11.1 Periodic Inspection In ensuring safe use please make sure ALLUX™ has a periodic inspection after 2 years of use. The periodic inspection will be performed free of charge within the warranty period. After the warranty period has expired, the periodic inspection will be performed at the user’s expense. The worn parts (extension stopper rubber and rubber pads) attached to ALLUX will be replaced free of charge if they have deteriorated during the periodic inspection within the... -
Page 37: Warranty
■When failure or damage occurs after the warranty period has expired. ■ When failure or damage is caused by adjustment by a party other than those certified by Nabtesco or the Distributor. ■ When failure or damage is caused by use without periodic inspection. -
Page 38: Warranty Periods Of Designated Devices
Warranty 12.2 Warranty periods of designated devices The warranty periods of the designated devices used for ALLUX , such as the battery charger, are shown in the following table. Charging port cap 1 year NE-CC01 Power OFF cap 1 year NE-CC02 Backup battery pac 1 year... -
Page 39: Repair
Warranty 12.3 Repair 1） If the cause of defect is unclear, the measures will be determined through consultation between the customer and the Distributor. 2） Repair of external painting will be performed at the user’s expense. Ask the Distributor for estimation. -
Page 40: Symbols Used
Symbols Used 13.1 UDI label (Packing box) Legal manufacturer Made date Item number Medical Device Global Trade Serial number Item Number GTIN Authorized representative for EU countries The maximum and minimum temperatures for storing, transporting, and using the product. Declaration of conformity according to the European Regulation 2017/745 Single patient multiple use 13.2 Serial number label (Charging port) -
Page 41: Ac Adapter Label (Ac Adapter)
Symbols Used 13.5 AC adapter label (AC adapter) It certifies that this product complies with UL safety standards. Compliance with the requirements according to FCC Charge it indoors. Energy efficiency level 5 CB mark （Safety tests based on IEC standards） RCM mark （Safety standards for Oceania）... -
Page 42: Backup.battery.label（.Backup.battery.pac
Symbols Used 13.6 Backup battery label （Backup battery pac） It certifies that this product complies with UL safety 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. - Page 43 MEMO...
- Page 44 Manufacture Authorized representative for EU countries Nabtesco Corporation PROTEOR SAS 6 rue de la Redoute Accessibility Innovations Company 21850 Saint-Apollinaire Assistive Products Department France 35, Uozakihama-machi, Higashinada-ku KOBE, 658-0024, JAPAN TEL: +33 3 80 78 42 42 Phone: +81-78-413-2724 FAX: +33 3 80 78 42 15 Fax: +81-78-413-2725 cs@proteor.com...