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Otto Bock Genium X3 3B5-2 User Manual

Otto Bock Genium X3 3B5-2
56 pages
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Genium X3 3B5-2/3B5-2=ST
Instructions for use (qualified personnel) ................................................................. 5

Table of Contents

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Otto Bock Genium X3 3B5-2 Specifications

General IconGeneral
BrandOtto Bock
ModelGenium X3 3B5-2
CategoryMedical Equipment
LanguageEnglish

Summary

Important Information

Remote Control Version Requirement

Ensure remote control compatibility by checking version 1.0.0.6 or higher for full functionality.

Product Description

Product Design and Components

Details the components of the prosthesis, including the proximal pyramid adapter, battery, and hydraulic unit.

Product Functionality

Explains the microprocessor-controlled stance and swing phase functionality and adaptive features.

Combination Possibilities

Lists compatible Ottobock components, including adapters, tube adapters, prosthetic feet, and implant system connections.

Product Application

Indications for Use

Specifies that the product is solely for lower limb exoprosthetic fittings.

Area of Application Classification

Defines the application area according to Ottobock's MOBIS classification.

Conditions of Use

Details intended everyday use, not unusual activities, and limits body weight to 125 kg.

Patient Indications

Lists patient types for use, including amputees and dysmelia patients, requiring specific capabilities.

Required Personnel Qualification

States that fitting must be done by Ottobock-authorised qualified personnel with specific training.

Safety Information

Explanation of Warning Symbols

Defines the meaning of WARNING, CAUTION, and NOTICE symbols for potential hazards and damage.

Structure of Safety Instructions

Explains how safety instructions are presented, including hazard source, consequences, and required actions.

General Safety Instructions

Covers warnings for non-observance, use of damaged parts, and handling the power supply unit.

Power Supply and Battery Charging Safety

Addresses safety regarding power supply use, charging, and potential damage from incorrect voltage or polarity.

Battery Charger Safety

Details safety precautions for battery charger operation, including avoiding dirt, mechanical stress, and incorrect usage.

Alignment and Adjustment Safety

Safety notes on using suitable components, proper screw assembly, and alignment procedures to prevent falls or breakage.

Proximity and Environmental Safety

Warns about HF devices, magnetic fields, and temperature ranges affecting product performance and safety.

Usage Safety and Precautions

Covers safety during walking, climbing stairs, overcoming obstacles, and handling mode switching or stance function.

Safety Modes and Operations

Discusses safety mode, implant system loads, and cockpit app usage safety to prevent unexpected behaviour.

Scope of Delivery and Accessories

Scope of Delivery Items

Lists all components included in the product package, such as the prosthesis, adapters, power supply, and documentation.

Available Accessories

Lists optional components that can be ordered separately, like protective covers and remote controls.

Charging the Battery

Connecting Power Supply and Charger

Step-by-step guide on connecting the power supply and battery charger to the wall outlet and the prosthesis.

Prosthesis Battery Charging Process

Details the process of connecting the inductive charger and indicators for charging status.

Displaying Current Battery Charge Level

Explains how to check the battery level using beep signals, the Cockpit app, or the remote control.

Preparation for Use

Prosthesis Alignment

Guidance on connecting the knee joint to a prosthetic socket and ensuring biomechanically correct alignment.

X-Soft Adjustment Software Setup

Details on using the X-Soft software for patient-specific product settings and software updates.

Tube Adapter Shortening Procedure

Instructions for correctly shortening the tube adapter, ensuring cable integrity and proper fit.

Tube Adapter Installation

Steps for installing the tube adapter, connecting cables, and ensuring correct insertion depth and torque.

Bench Alignment Procedures

Guidelines for bench alignment using apparatus or laserline, emphasizing correct shoe usage and full extension.

Static Alignment Optimisation

Using adjustment software for concrete reference values to optimise alignment for minimal patient compensation.

Dynamic Alignment Optimisation

Performing dynamic optimisation during trial walking, adapting aspects like socket position and foot rotation.

Screw Connection Torque Values

Specifies the correct torque values for various screw connections to ensure secure assembly.

Socket Check After Bench Alignment

Verifying distances between the socket and knee joint at maximum flexion/extension to prevent collision and damage.

Flexion Stop Installation and Removal

Details on the knee joint's flexion stop, its purpose, types, and procedures for removal and insertion.

Cockpit App Usage

Cockpit App System Requirements

Lists compatible Android devices and operating system versions for the Cockpit app.

Initial Cockpit App Connection

Key points to observe before establishing the first connection, including Bluetooth activation and device requirements.

First-Time Cockpit App Startup

Steps for launching the app, accepting the EULA, and adding a new component.

Cockpit App Control Elements

Overview of the app's interface, including navigation menu, product status, and mode selection.

Cockpit App Navigation Menu

Details the options available in the navigation menu, such as Product, MyModes, Functions, and Settings.

Managing Connected Components

Information on storing and managing connections with up to four components, and adding new components.

Adding a New Component to Cockpit App

Step-by-step instructions for adding a new prosthesis or device to the Cockpit app.

Deleting Components from Cockpit App

Procedure for removing a component from the app's stored connections.

Connecting Component to Multiple Devices

Guidance on managing component connections across different devices and handling connection conflicts.

Using the Prosthesis

Basic Mode Movement Patterns

Describes basic mode functionality, including standing, walking, and sitting, and the stance function.

Standing Functionality

Details the knee joint's control during standing, including intuitive and deliberate locking mechanisms.

Stance Function Activation

Explains how to enable and use the stance function for improved stability on inclines.

Walking Procedure

Instructions for walking with the prosthesis, emphasizing stance and swing phase control by hydraulics.

Short Distance Running Function

Details the automatic transition to running, changes in swing phase angle, and preFlex reduction.

Sitting Down Technique

Guidance on how to sit down, ensuring controlled flexion and weight distribution.

Sitting Posture and Energy Saving

Describes the energy saving mode during sitting and the optional sitting function for free leg swing.

Standing Up Technique

Steps for standing up, involving foot placement, body lean, and weight distribution.

Walking Up Stairs (Step-over-Step)

Instructions for negotiating stairs step-by-step, requiring practice and conscious execution.

Crossing Obstacles

How to use the stair function to cross obstacles, involving hip extension and flexion.

Walking Down Stairs Technique

Procedure for walking down stairs, ensuring correct foot placement and controlled flexion.

Walking Down a Ramp

Using increased flexion resistance to permit controlled knee flexion when walking down a ramp.

Changing Prosthesis Settings

How to adjust prosthesis settings using the Cockpit app or remote control, including checking selected prosthesis.

Adjusting Settings via Cockpit App

Step-by-step guide to changing parameters like resistance, angle, and function activation within the Cockpit app.

Basic Mode Adjustment Parameters

Details parameters adjustable in basic mode, including resistance, angle, and activating/deactivating functions.

MyMode Adjustment Parameters

Lists modifiable parameters for MyModes, such as gain, pitch, volume, and stance function for specific motion patterns.

MyModes for Specific Activities

Running MyMode Configuration

Describes the 'Running' MyMode for extended periods, including its configuration and compatible prosthetic feet.

Switching MyModes via Cockpit App

How to select different MyModes using the Cockpit app after establishing a connection.

Switching MyModes Using Motion Patterns

Procedure for switching between MyModes by performing specific motion patterns, with requirements and sequence.

Return to Basic Mode from MyMode

Methods to switch back to basic mode from a MyMode, using motion patterns or the battery charger.

Additional Operating States

Empty Battery Mode Operation

Describes the state when the battery is critically low, leading to safety mode damping and eventual shutdown.

Prosthesis Charging Mode

Indicates the prosthesis is non-functional during charging and defaults to safety mode damping.

Safety Mode Functionality

Explains activation of safety mode due to critical faults, its limited functionality, and deactivation procedures.

Overheating Mode

Describes overheating mode activation due to high activity, its indication, and deactivated functions.

Storage and Hydraulic Bleeding

Guidance on proper storage to prevent hydraulic issues and information on the automatic bleeding mechanism.

Product Cleaning Instructions

Steps for cleaning the product using fresh water, drying, and air drying.

Product Maintenance

Product Identification by Service Center

Methods for identifying the product's settings (factory or user) by an authorised service center.

Legal Information

Manufacturer Liability Disclaimer

Defines the manufacturer's liability based on product use according to instructions and disclaims liability for misuse.

Product Trademarks

Information that product names are subject to trademark laws and belong to their respective owners.

CE Conformity and Directives

States compliance with European directives for medical devices, radio equipment, and RoHS.

Local Legal Information (FCC, IC)

Covers FCC and Industry Canada compliance, including rules on interference and RF exposure.

Technical Data and Environmental Conditions

Environmental Conditions

Details operating, storage, and transportation conditions including temperature and humidity limits.

Product Specifications

Provides key product details like article number, weight, maximum body weight, and protection rating.

Battery and Charger Specifications

Lists specifications for the prosthesis battery, power supply, and battery charger, including charging times.

Cockpit App Technical Details

Provides the article number for the Cockpit app.

Appendices and Symbols

Symbols Used in Documentation

Explains the meaning of various symbols used throughout the manual, such as legal manufacturer, IP ratings, and CE marking.

Operating State Signals

Lists signals for battery charger connection, disconnection, and mode switching events.

Warning and Error Signals

Describes error signals like overheating, low battery, and safety mode activation, with required actions.

Cockpit App Connection Error Messages

Lists error messages during app connection, causes, and corrections, e.g., device not found or connection interrupted.

Status Signals Overview

Provides status signals related to the battery charger, including connection status and errors.

Maintenance and Self-Test Signals

Details signals for maintenance notes and self-test errors, including required actions and product usage.

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