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Otto Bock Genium 3B1 User Manual

Otto Bock Genium 3B1
100 pages
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Genium 3B1/3B1=ST
Gebrauchsanweisung (Fachpersonal)..................................................................... 5
Instructions for use (qualified personnel) ................................................................. 51

Table of Contents

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Otto Bock Genium 3B1 Specifications

General IconGeneral
ManufacturerOttobock
Microprocessor ControlYes
Stance Phase ControlYes
Swing Phase ControlYes
Intuitive Stance Function (ISF)Yes
Bluetooth ConnectivityYes
Compatible with Myo PlusYes
Product TypeProsthetic Knee Joint
Maximum Body Weight125 kg
Battery LifeUp to 5 days
Water ResistanceIP67
Charging Time3 hours
Activity LevelsModerate to high activity levels (K3/K4)

Summary

Important Information

Remote Control Version Requirement

Remote control functionality requires version 1.0.0.6 or higher for the knee joint and remote.

X-Soft Adjustment Software Version

Specifies X-Soft 4X1 version 1.4 or higher is needed for knee joint adjustment.

Foreword

Product Description

3.1 Design

Details the components of the Genium prosthesis, including adapters, battery, and hydraulic unit.

3.2 Function

Explains the microprocessor control, sensor system, and hydraulic unit for dynamic gait adaptation.

3.3 Combination Possibilities

Lists compatible Ottobock components that can be combined with the Genium prosthesis.

Application

4.1 Indications for Use

Specifies the intended use of the product for lower limb exoprosthetic fittings.

4.2 Area of Application

Defines the product's application area according to the MOBIS mobility system.

4.3 Conditions of Use

Outlines the product's development for everyday use and restrictions on unusual activities.

4.4 Indications

Lists patient categories for whom the product is indicated, including amputation types and requirements.

4.5 Qualification

States that fitting must be performed only by qualified Ottobock-authorized personnel.

Safety

5.1 Explanation of Warning Symbols

Defines the meaning of WARNING, CAUTION, and NOTICE symbols used in the safety instructions.

5.2 Structure of the Safety Instructions

Explains the structure of safety instructions, including hazard source, consequences, and required actions.

5.3 General Safety Instructions

Provides general safety warnings regarding power supply, charger, and component manipulation.

Specific Safety Cautions

Covers safety advice on mechanical stress, battery levels, pinching risks, dirt, transport, and component wear.

5.4 Information on the Power Supply/Battery Charging

Details safety precautions for charging the product, including charger use and compatibility.

5.5 Battery Charger Information

Provides notices on product care, charging, and potential issues with battery chargers.

5.6 Information on Alignment/Adjustment

Highlights safety concerns related to component compatibility, assembly, and connection during adjustment.

5.7 Information on Proximity to Certain Areas

Advises on maintaining safe distances from HF devices and sources of interference.

5.8 Information on Use

Provides safety guidance for specific use cases like walking up/down stairs and handling overheating.

5.9 Notes on the Safety Modes

Explains precautions for using and managing safety modes, including potential activation/deactivation issues.

5.10 Information on the Use of a Mobile Device with the Cockpit App

Details safety aspects of using mobile devices with the cockpit app, including improper use and modifications.

Scope of Delivery and Accessories

Scope of Delivery

Lists all items included in the product package.

Accessories

Lists optional accessories that can be ordered separately for the product.

Charging the Battery

7.1 Connecting the Power Supply and Battery Charger

Provides step-by-step instructions for connecting the power supply and battery charger.

7.2 Charging the Prosthesis Battery

Details the process of charging the prosthesis battery using the inductive charger.

7.3 Display of the Current Charge Level

Explains methods to check the battery charge level via beep signals, Cockpit app, or remote control.

Preparation for Use

8.1 Alignment

Details the requirements and initial steps for aligning the prosthesis using adjustment software.

8.1.1 Shortening the Tube Adapter

Provides instructions and safety precautions for shortening the tube adapter.

8.1.2 Installing the Tube Adapter

Guides through the process of installing the tube adapter, including screw torques and cable connections.

8.1.3 Adjusting the Torsion Moment on the 2R21 AXON Tube Adapter

Explains how to adjust the torsion moment on the 2R21 AXON tube adapter.

8.1.4 Bench Alignment in Alignment Apparatus

Describes bench alignment procedures using specialized apparatus or laser/plumb line.

8.1.5 Static Alignment Optimisation

Details static alignment optimization using adjustment software and patient compensation.

8.1.6 Dynamic Alignment Optimisation

Explains dynamic alignment optimization through trial walking and component adjustments.

8.1.7 Torque Values of the Screw Connections

Specifies required torque values for securing screw connections during prosthesis assembly.

8.1.8 Checking the Socket After Bench Alignment

Provides procedures for checking socket clearance at maximum flexion and extension after alignment.

8.1.9 Flexion Stop

Explains the function of flexion stops and lists available options for limiting the knee's flexion angle.

Removing the Flexion Stop

Details the steps and precautions for removing the flexion stop from the knee joint.

Inserting the Flexion Stop

Provides instructions for installing and securing a flexion stop with thread locking compound.

8.2 Optional: Installing the Foam Cover

Guides on how to move the inductive charging receiver when installing a cosmetic foam cover.

Cockpit App

9.1 System Requirements

Lists the Android OS version and tested devices required for the Cockpit app functionality.

9.2 Initial Connection Between Cockpit App and Prosthesis

Outlines prerequisites for establishing the initial connection between the Cockpit app and the prosthesis.

9.2.1 Starting the Cockpit App for the First Time

Details the initial setup steps for the Cockpit app, including EULA acceptance and component addition.

9.3 Control Elements for Cockpit App

Explains the various control elements and indicators displayed within the Cockpit app interface.

9.3.1 Cockpit App Navigation Menu

Describes the navigation menu structure and functions available within the Cockpit app.

9.4 Managing Prostheses

Covers managing multiple prosthesis connections, including adding and deleting components.

9.4.1 Adding Component

Step-by-step guide on adding a new prosthesis component to the Cockpit app.

9.4.2 Deleting a Component

Instructions for removing a prosthesis component from the Cockpit app.

9.4.3 Connecting Component with Multiple Devices

Explains how to connect the prosthesis to different devices, managing existing connections.

Use

10.1 Movement Patterns in Basic Mode (Mode 1)

Describes basic movement patterns and the stance function in the default mode.

10.1.1 Standing

Details the stance function, its activation, and its benefits for standing on inclined surfaces.

10.1.2 Walking

Explains the initial walking process, emphasizing stabilization and swing phase control.

10.1.3 Running Short Distances ('Walk-to-Run' Function)

Describes the 'walk-to-run' function for quick short-distance movement and its settings.

10.1.4 Sitting Down

Details the process of sitting down, including weight distribution and body posture.

10.1.5 Sitting

Explains the sitting function's activation, resistance reduction in flexion/extension, and its effect on prosthetic leg swing.

10.1.6 Standing Up

Provides instructions for standing up, including body posture and weight distribution.

10.1.7 Walking Up Stairs Step-over-Step

Details the technique for negotiating stairs step-over-step, emphasizing practice and conscious execution.

10.1.8 Overcoming Obstacles

Describes how to use the stair function to cross obstacles, including hip and knee movements.

10.1.9 Walking Down Stairs

Outlines the procedure for walking down stairs, focusing on foot positioning and controlled flexion.

10.1.10 Walking Down a Ramp

Explains how to manage controlled flexion when walking down a ramp using increased resistance.

10.2 MyModes

Introduces MyModes for specific motion patterns and their configuration via software, app, or remote.

10.2.1 Switching MyModes with the Cockpit App

Details how to switch between MyModes using the Cockpit app, requiring Bluetooth connection.

10.2.2 Switching MyModes Using Motion Patterns

Explains how to switch MyModes by performing specific movement patterns, with requirements and process.

10.2.3 Switching from a MyMode Back to Basic Mode

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

10.3 Changing Prosthesis Settings

Explains how to adjust prosthesis settings for the currently active mode using the Cockpit app or remote control.

10.3.1 Changing the Prosthesis Setting Using the Cockpit App

Step-by-step guide on changing prosthesis settings for a selected mode within the Cockpit app.

10.3.2 Overview of Adjustment Parameters in Basic Mode

Lists and defines adjustable parameters in basic mode for dynamic gait behavior, including stance and stairs functions.

10.3.3 Overview of Adjustment Parameters in MyModes

Details adjustable parameters within MyModes for specific motion patterns like 'Brake knee'.

10.4 Turning Bluetooth on the Prosthesis On/Off

Explains how to enable or disable the prosthesis's Bluetooth function for app connectivity.

10.4.1 Switching Bluetooth Off/On Using the Cockpit App

Provides instructions on controlling Bluetooth via the Cockpit app for connection management.

10.5 Querying the Prosthesis Status

Details how to access the prosthesis status information using the Cockpit app or remote control.

10.6 Mute Mode (Silent Mode)

Explains mute mode, which turns off audible and vibration feedback signals, and its activation.

10.6.1 Turning Mute Mode On/Off Using the Cockpit App

Instructions for activating and deactivating mute mode via the Cockpit app interface.

10.6.2 Turning Mute Mode On/Off Using the Remote Control

Details how to toggle mute mode using the optional remote control's status menu.

10.7 Deep Sleep Mode

Describes deep sleep mode for minimizing power consumption and how to awaken the prosthesis.

10.7.1 Turning Deep Sleep Mode On/Off Using the Cockpit App

Guides on activating and deactivating deep sleep mode through the Cockpit app.

10.7.2 Turning Deep Sleep Mode On/Off Using the Remote Control

Explains how to activate and deactivate deep sleep mode using the device settings on the remote control.

10.8 OPG Function (Optimised Physiological Gait)

Details the OPG function, which promotes biomechanically correct walking and enhances features like PreFlex and adaptive control.

Additional Operating States (Modes)

11.1 Empty Battery Mode

Describes the empty battery mode, its signals, safety mode damping, and how to switch back.

11.2 Mode for Charging the Prosthesis

Explains the product's non-functional state during charging and its setting to safety mode damping.

11.3 Safety Mode

Covers automatic switching to safety mode upon critical faults, its indication, and how to disable it.

11.4 Overheating Mode

Explains overheating mode, its triggers, indication, deactivated functions, and the product's behavior.

Storage and Bleeding

Cleaning

Maintenance

Legal Information

15.1 Liability

States the manufacturer's liability conditions regarding product use and disregard of the document.

15.2 Trademarks

Addresses product names, brands, and trade names as registered trademarks and their ownership.

15.3 CE Conformity

Confirms the product meets European directives for medical devices and radio equipment.

15.4 Local Legal Information

Covers FCC compliance rules and conditions for device operation in the USA.

Appendices

16.1 Symbols Used

Lists and explains symbols found on the product, including legal manufacturer and compliance marks.

16.1.1 Symbols on the Product

Lists and explains symbols found on the product, including legal manufacturer and compliance marks.

16.1.2 Symbols on the Battery Charger

Explains symbols found on the battery charger, such as legal manufacturer, lot number, and IP rating.

16.2 Operating States/Error Signals

Details beep and vibration signals indicating operating states like charging and mode switching.

16.2.1 Signals for Operating States

Details beep and vibration signals indicating operating states like charging and mode switching.

16.2.2 Warnings/Error Signals

Lists warnings and error signals, their causes, and required actions for issues like overheating or low battery.

16.2.3 Error Messages While Establishing a Connection with the Cockpit App

Lists error messages encountered during cockpit app connection, their causes, and correction steps.

16.2.4 Status Signals

Describes status signals for battery charger connection and disconnection, and self-test completion.

16.3 Technical Data

Provides technical specifications including environmental conditions, product details, and mobility grades.

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