Related Manuals for Nabtesco ALLUX NE-Z4
Summary of Contents for Nabtesco ALLUX NE-Z4
- Page 1 User’s Guide Type：NE-Z4,NE-Z4SH Number：81-SS00092 Date of issue：July 31, 2015 ・Carefully read the User’s Guide prior to use. ・Keep this User’s Guide for future reference.
- Page 3 This user’s guide (hereinafter, referred to as this document) provides you with information to ensure that you can safely use our product, Nabtesco ALLUX Keep the document with the attached “Warranty.” ◆ Instructions for safe use...
- Page 4 Doing so can cause injury or damage ALLUX Cautions for handling ALLUX safely Nabtesco Corporation (hereinafter, referred to as our company) cannot foresee all off 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 5 ALLUX 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 Directive 1999/5/EC.
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Page 6: About This Document
About This Document About This Document Target of this document This document is intended for prosthesis users using ALLUX Copyright Our company 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 agreement When this document is lost or damaged If this document or any related document is lost or damaged, immediately ask us to reissue it. - Page 7 Warranty Warranty 1) The warranty period of the main body of the product is 3 years (basic contract) after the day of purchase while designated equipment 1 year. Only if failure or damage is caused by inadequacies of design or manufacture of the equipment supplied by us during the warranty period although it is used normally, we will repair or replace the relevant part(s).
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Page 8: Service (Contact Information)
Service Service (Contact Information) In the following cases, contact the distributor or our company. When you have questions about adjustment or maintenance of ALLUX When you want to purchase replacement parts for maintenance When you want to ask us for periodic inspection When you have questions about the copyright of this document for copy or reference... - Page 9 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 Certification of international Expected performance under normal use of ALLUX standard Information on EMC...
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Page 10: Table Of Contents
Table of Contents Table of Contents Introduction． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ．i Important Information．... -
Page 11: Table Of Contents
Table of Contents Charging Procedure ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． 15 6.1 Charging ALLUX 6.1.1 Specifications for charger and AC adapter．... -
Page 12: Safety Precautions
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. Indicates a potentially hazardous situation which, if not avoided, could result in death or serious injury. -
Page 13: Warning
1. Safety Precautions 1.2 Warning Strictly observe the following instructions to use the product safely. • Before using, read this User’s Guide, and understand the instructions for use. • When there is abnormal noise, play or reduction in hydraulic resistance, discontinue the use, and contact us. •... -
Page 14: Caution． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ．3
1. Safety Precautions 1.3 Caution Strictly observe the following instructions to use the product safely. • Adjust ALLUX in the presence of someone from our company. (At the start of the field test) • Charge the main body of ALLUX before using it on the user. •... -
Page 15: Product Overview
2. Specifications 2 Product Overview 2.1 Introduction of ALLUX ALLUX is a knee joint with a four-Bar linkage mechanism to electronically control the stance and swing phases. It realizes smooth walking according to the walking speed andenables yielding required for descending a slope or stairs. -
Page 16: Before Use
3. Before Use Before Use 3.1 Parts list The package of ALLUX contains the following parts. [Main body and accessories] ALLUX 1 pc. NE-Z4 Instruction manual 1 copy 81-SS00091(for prosthetists) User’s Guide 1 copy 81-SS00092(this document) Warranty 1 copy 81-SO00617 Backup battery case 1 pc. -
Page 17: Safe Posture
4. Safe Posture 4 Safe Posture 4.1 Safe posture and get ready for communication Safe posture is taken to change the mode of ALLUX beforeusing the remote commander and communicating with ALLUX software. ALLUX takes 30 seconds to get ready for communication after you slightly bend or extended. -
Page 18: Function
5. Functions Functions 5.1 Modes of ALLUX ALLUX has charging mode, backup battery connecting mode, high-temperature mode, battery run out mode and modes configured by software that can selected by the remote controller,. When the mode is changed , the vibration will notice the user about the mode change. The internal power supply of ALLUX was designed to last for 2 days when the number of steps taken by the prosthesis is 3000/day. -
Page 19: Normal Usage Condition
5. Functions 5.2 Normal usage condition 5.2.1 In normal state When the charger (NE-BC01) or the power OFF connector (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 20: When Residual Battery Capacity Is Low． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ．9
5. Functions 5.2.3 When residual battery capacity is low When the internal battery capacity allows for less than 30 minutes of walking, the warning vibration will be activated. When the battery is exhausted, the control of ALLUX will be stopped. Connecting the backup battery (NE-DB01) before the internal battery runs out enables the user to use ALLUX continuously for one day. -
Page 21: Battery Exhaustion． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ．10
5. Functions 5.2.4 Battery exhaustion When the internal power supply has exhausted and ALLUX 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 ALLUX will be locked (yielding resistance with high flexion resistance). -
Page 22: N High Temperature State． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ．11
5. Functions 5.2.5 In high-temperature state If walking with the yielding function is continued for several tens of minutes, ALLUX be heated to a high temperature. When the temperature of ALLUX rises, the vibration for warning about increasing temperature will sound at first. In this state, the user can walk. If ALLUX is used continuously, the vibration for alerting the user to stop using due to high temperature will be given. -
Page 23: Operation By Remote Controller． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ．12
5. Functions 5.3 Operation by remove controller ALLUX can be switched to any mode set in 5.13 by using the remote controller (NE-RC01). When the remote controller button is held down for 1.5 seconds or more within 30 seconds after the user finished flexing and extending his/her knee and while the user is in the safe posture, the vibration will sound, and ALLUX will be switched to the specified mode. -
Page 24: Backup Battery． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ．13
5. Functions 5.5 Backup battery Connecting the battery and product The user must carry the backup battery (NE-SB01) at all times. It will be used when the battery in the main body of ALLUX has been exhausted and the warning vibration is given or the knee is locked due to battery exhaustion. -
Page 25: Specifications For Backup Battery． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ．14
5. Functions 5.5.1 Specifications for backup battery ・ Service temperature: 0ºC to 40ºC ・ Resistance to ambient temperature: -20ºC to 80ºC ・ Resistance to ambient humidity: 10 to 90%RH ・ Charger: N-BC01 ・ Applicable device: ALLUX (NE-Z4 or NE-Z4SH) ・ Service life: 2 years - 14 -... - Page 26 6. Charging Procedures 6 Charging Procedures 6.1 Charging ALLUX The internal power supply of ALLUX and backup battery shall be charged with the special charger (NE-BC01). When using ALLUX , it is recommended to charge it every day as a rule.
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Page 27: Charging Procedure
6. Charging Procedures 6.1.2 Charging procedure Connect the charger (NE-BC01) and AC adapter (NE-AD01) indoors, and charge the battery through a commercial power supply. 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 28: Charging The Backup Battery． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ．17
6. Charging Procedures The LED lamp on the charger will light on in orange. * If the temperature of ALLUX is higher than 40ºC 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 29: Indication By Led Lamp On Charger． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ．18
6. Charging Procedures 6.1.4 Indication by LED lamp on charger The LED lamp on the 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 charger or the AC adapter may be defective. -
Page 30: Service Parts
7. Service Parts 7 Maintenance Parts 7.1 List of maintenance parts During periodic inspection, the following maintenance parts are used [Replacement of battery] If the battery life is coming to an end, receive the main body of ALLUX , and Main body of ALLUX return it to our company. -
Page 31: Troubleshooting
8. Troubleshooting 8 Troubleshooting 8.1 Troubleshooting list If any problem occurs during adjustment or assembly of ALLUX , see the following list. If an appropriate item is not shown in the list, contact the prosthesis manufacturer or our company. 8.1.1 While in use Problem Check item Remedy... - Page 32 8. Troubleshooting Problem Check item Remedy Check for foreign Abnormal noise or backlash Check that there are no substances. occurs. screws, etc. between knee joint linking parts. Check that the connections Contact the our of the knee joint and foot are company not loose.
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Page 33: Disposal． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ． ．22
9. Disposal Disposal The table below shows the materials of the ALLUX knee unit in each component. When disposing of the knee joint, comply with the rules stipulated in the local community. Classification Part name Remarks of material Carbon fiber reinforced composite material. Frame Plastic Aluminum structural parts are inserted in it. -
Page 34: Periodic Inspection
10. Periodic Inspection 10 Periodic Inspection 10.1 Periodic Inspection ALLUX shall undergo periodic inspection every year after the start 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...