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BionX BiOM T2 Ankle User Manual

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Instructions for Use
BiOM
®
T2 Ankle
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BionX BiOM T2 Ankle Specifications

General IconGeneral
Power SourceBattery
ModelBiOM T2 Ankle
ManufacturerBionX Medical Technologies, Inc. (Now iWalk)
TypeAnkle-foot prosthesis
BrandBionX (iWalk)
MaterialTitanium, Aluminum, Polymers

Summary

INTRODUCTION

INDICATIONS FOR USE

Specifies the intended medical purpose and eligible amputations for the BIOM T2 Ankle.

SAFETY PRECAUTIONS

Outlines critical safety guidelines and warnings to prevent injury and device malfunction.

PRODUCT OVERVIEW

SAFETY STANDARDS AND CLASSIFICATIONS

Details the safety standards, classifications, and certifications the Ankle complies with.

SYSTEM COMPONENTS AND ACCESSORIES DESCRIPTION

Lists and describes the various components and accessories included with the BIOM T2 Ankle system.

ANKLE SPECIFICATIONS

Provides detailed technical specifications for the Ankle, including weight, dimensions, and range of motion.

BATTERY SPECIFICATIONS

Lists technical specifications for the rechargeable Lithium-Ion battery, such as voltage and capacity.

CHARGER SPECIFICATIONS

Details the technical specifications for the battery charger, including input, output, and operating conditions.

INDICATORS

VISUAL

Explains the visual cues, such as LED lights, used to indicate the Ankle's status and battery level.

TACTILE

Describes the tactile feedback (vibrations) provided by the Ankle to alert the user about battery status.

POWERING ON/OFF

SETUP

ALIGNMENT

Guides the user through the initial alignment process for the Ankle, including transtibial and transfemoral applications.

STATIC ALIGNMENT

Details the steps for ensuring correct static alignment of the prosthesis for a level pelvis and flat foot.

DYNAMIC ALIGNMENT

Explains how to fine-tune the Ankle's alignment during movement for optimal gait characteristics.

ATTACH FOOT MODULE

Provides step-by-step instructions for attaching the Foot Module to the Ankle assembly.

REMOVE FOOT MODULE

Outlines the procedure for safely removing the Foot Module from the Ankle for maintenance or replacement.

HARDSTOP COVER

Describes how to attach the Hardstop Cover to protect the Ankle joint from snagging.

TUNING

CONNECT TO THE ANKLE

Guides the user on connecting the BIOM Ankle to the tuning application via Bluetooth.

TROUBLESHOOT CONNECTION

Offers solutions for common issues encountered when connecting the Ankle to the tuning application.

PAIRING THE ANKLE WITH THE PERSONAL BIONICS TUNING APP

Details the process of pairing the BIOM Ankle with the tuning device using Bluetooth settings.

TUNE THE ANKLE

Explains the basic and advanced settings for tuning the Ankle's performance to the user's needs.

GENERATE AN ANKLE TUNING RECORD

Describes how to generate and save a tuning record using the Net Work Graph and application.

TROUBLESHOOT TUNING

Provides solutions for common tuning issues and explains how alignment changes affect Ankle response.

BATTERY AND CHARGER

BATTERY DETAILS

Provides comprehensive specifications and operational details for the rechargeable Lithium-Ion battery.

CHARGER SPECIFICATIONS

Details the technical specifications for the BIOM battery charger, including power requirements and environmental conditions.

CHARGE THE BATTERY

Step-by-step instructions for charging the BIOM Ankle battery correctly and safely.

CLEANING BATTERY AND CHARGER

Guidance on how to clean the battery and charger components using appropriate methods.

BATTERY MANAGEMENT

Offers tips and best practices for managing the battery to ensure optimal longevity and performance.

EXTENDING SHELF LIFE

Explains how to properly store batteries to maintain their capacity and extend their shelf life.

UNDERSTANDING SLEEP MODE

Describes the device's sleep mode and how it affects the Ankle's powered functionality.

ANKLE WILL NOT POWER ON

Troubleshooting steps for when the BIOM Ankle fails to power on, including battery checks.

BATTERY AND CHARGER SAFETY PRECAUTIONS

Crucial safety warnings and precautions related to the handling, charging, and use of the battery and charger.

TROUBLESHOOT BATTERY AND CHARGER

Provides solutions for common issues related to battery charging, fitting, and indicator lights.

MAINTENANCE

SERVICE

Recommends regular inspections of the Ankle for signs of unusual wear and tear.

CLEANING

Instructions for cleaning the Ankle, Foot Cover, and Foot Module using recommended methods.

RETUNING

Advises on when and how the Ankle should be retuned by a professional for optimal performance.

REPAIRS

Information on contacting customer service for repairs and limitations on self-repair.

TRANSPORT

Guidelines for safely transporting the Ankle and its batteries, including air travel considerations.

DISPOSAL

Instructions for the proper and safe disposal of Lithium-Ion batteries.

WARRANTY

WHAT DOES THIS LIMITED WARRANTY COVER?

Details the specific components and materials covered under the limited warranty.

WHAT IS NOT COVERED BY THIS WARRANTY?

Lists conditions, damages, and usage scenarios that are excluded from the warranty coverage.

HOW LONG DOES THE COVERAGE LAST?

Specifies the duration of the limited warranty for the Ankle, Charger, and Batteries.

WHAT WILL THE COMPANY DO IF THERE IS A MATERIAL DEFECT?

Explains the company's procedure for addressing material defects under the warranty terms.

WARRANTY DISCLAIMERS

Legal disclaimers regarding implied warranties of merchantability and fitness for a particular purpose.

LIMITS ON LIABILITY

Outlines the extent of the company's liability for damages arising from the device's use.

AUTHORIZED PROSTHETISTS

States that warranty service is contingent on using company-approved prosthetists.

RETURN POLICY

Clarifies the company's policy regarding returns of the Ankle and its accessories.

EMC PRECAUTIONS - ANKLE

ELECTROMAGNETIC EMISSIONS

Provides guidance on electromagnetic emissions and the Ankle's compliance with relevant standards.

ELECTROMAGNETIC IMMUNITY

Details the Ankle's immunity to electromagnetic interference and recommended usage environments.

EMC PRECAUTIONS - CHARGER

ELECTROMAGNETIC EMISSIONS

Explains the electromagnetic emissions characteristics of the Battery Charger and its compliance.

ELECTROMAGNETIC IMMUNITY

Details the Battery Charger's immunity to electromagnetic fields and the conditions for its use.