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Otto Bock Genium User Manual

Otto Bock Genium
108 pages
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Genium 3B1-3/3B1-3=ST
Gebrauchsanweisung (Fachpersonal)..................................................................... 9
Instructions for use (qualified personnel) ................................................................. 57

Table of Contents

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Otto Bock Genium Specifications

General IconGeneral
Adaptive Swing Phase ControlYes
Stance Phase ControlYes
TypeProsthetic Knee
Maximum Load125 kg
Control SystemMicroprocessor-controlled
ModesMultiple (walking, running, cycling, etc.)
Bluetooth ConnectivityYes
Charging TimeApprox. 2 hours

Summary

Charging the battery

Connecting the power supply and battery charger

Steps to connect the power supply and battery charger correctly.

Charging the prosthesis battery

Guidance on charging the prosthesis battery, including alignment requirements.

Display of the current charge level

Methods to check the battery charge level without devices, via Cockpit app, or during charging.

Preparation for use

Alignment

Guidelines for aligning the knee joint to a prosthetic socket.

Shortening the Tube Adapter

Instructions on how to properly shorten the tube adapter.

Installing the Tube Adapter

Detailed steps for installing the tube adapter onto the prosthesis.

Static alignment optimisation

Dynamic alignment optimisation

Checking the socket after bench alignment

Symbols Used

Foreword

Product description

Design

Overview of the physical components of the Genium product.

Function

Explanation of how the Genium product operates and its key functions.

Combination possibilities

Combination with an osseointegrated implant system

Details on combining the product with osseointegrated implant systems.

Application

Indications for use

Specifies the intended uses for the Genium prosthesis.

Conditions of use

Outlines the conditions and limitations for using the product safely.

Indications

Lists the patient types and conditions for which the product is indicated.

Qualification

Specifies the required qualifications for fitting and applying the product.

Safety

Explanation of warning symbols

Explains the meaning of different warning symbols used in the manual.

Structure of the safety instructions

Describes the format and structure of safety instructions.

General safety instructions

Provides general safety guidelines and precautions for product operation.

Use of damaged power supply unit, adapter plug or battery charger

Warning about using damaged charging equipment.

Failure to observe warning/error signals

Consequences of not observing warning or error signals.

Failure to observe activated mute mode (silent mode)

Risks associated with not observing mute mode feedback.

Mechanical stress on the product

Use of the product when battery charge level is too low

Risk of pinching in the joint flexion area

Penetration of dirt and humidity into the product

Mechanical stress during transport

Signs of wear to the product components

Improper product care

Knee joint movement noise

Information on the Power Supply/Battery Charging

Charging the product without taking it off

Warning about charging the product while it is being worn.

Charging the product with damaged power supply unit/charger/charger cable

Caution regarding charging with damaged equipment.

Use of incorrect power supply unit/battery charger

Risk of damage from using unapproved charging accessories.

Operating the power supply unit/charger outside of the permissible temperature range

Independent changes or modifications carried out to the battery charger

Contact of the battery charger with magnetic data storage devices

Information on Alignment/Adjustment

Use of unsuitable prosthesis components

Risks of using incompatible prosthesis components.

Improper assembly of the screw connections

Hazards associated with improper assembly of screw connections.

Incorrectly secured screws

Risks of loose screws causing component breakage.

Incorrect alignment or assembly

Potential damage from misaligned or improperly assembled components.

Errors during prosthesis alignment

Insufficient insertion depth of the tube adapter

Operator errors during the adjustment process with the adjustment software

Safety mode flexion resistance set too low

Insufficient distance to HF communication devices

Proximity to sources of strong magnetic or electrical interference

Entering a room or area with strong magnetic fields

Remaining in areas outside the allowable temperature range

Information on Use

Walking up stairs

Guidance and precautions for walking up stairs.

Walking down stairs

Guidance and precautions for walking down stairs.

Overheating of the hydraulic unit due to uninterrupted, increased activity

Overloading due to unusual activities

Improper mode switching

Improper use of the stance function

Quickly pushing the hip forward with the prosthesis extended

Notes on the safety modes

Using the product in safety mode

Precautions and observations when using the product in safety mode.

Safety mode cannot be activated due to malfunction

Reasons why safety mode might not activate and required actions.

Safety mode cannot be deactivated

Scenarios where safety mode cannot be deactivated and required actions.

Safety signal occurs (ongoing vibration)

Actions to take when a safety signal (vibration) occurs.

Instructions for use with an osseointegrated implant system

Information on the use of a mobile device with the cockpit app

Improper use of the device

Risks of improper use of the mobile device with the app.

Improper use of the setting parameters in the MyModes

Risks of improperly adjusting parameters within MyModes.

Independently applied changes or modifications made to the device

Improper mode switching with the device

Destruction of the device due to falling or penetration of water

Failure to observe the system requirements for the installation of the cockpit app

Scope of Delivery and Accessories

Settings with the "X-Soft" adjustment software

Updating the X-Soft adjustment software

Instructions for downloading and installing updates for the X-Soft software.

Data transfer between the product and the PC

How to transfer product settings to a PC via Bluetooth.

Preparing the product to connect to the adjustment software

Steps to prepare the product for connection to the adjustment software.

Switching on Bluetooth

Adjusting the torsion moment on the 2R21 AXON tube adapter

Bench alignment in alignment apparatus

Flexion stop

Cockpit app

Recommended tools and materials

List of tools and materials needed for installing the inductive charging receiver.

System Requirements

Initial connection between cockpit app and prosthesis

Starting the cockpit app for the first time

Guide to launching and setting up the Cockpit app for initial use.

Control elements for cockpit app

Cockpit app navigation menu

Details on how to navigate and use the Cockpit app's menu.

Managing components

Adding component

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

Deleting a component

Instructions for removing a component from the Cockpit app.

Connecting component with multiple devices

How to connect a component to multiple devices.

Use

Movement patterns in basic mode (mode 1)

How to use the prosthesis in its default basic mode.

Standing

How the prosthesis functions and is used while standing.

Stance function

Details on enabling and using the stance function for stable standing.

Walking

Instructions for walking with the prosthesis.

Running short distances ("walk-to-run" function)

Sitting down

Sitting

Sitting function

Details on enabling and using the sitting function.

Standing up

Walking up stairs step-over-step

Overcoming obstacles

Walking down stairs

Walking down a ramp

Configuration for walking down stairs/ramp using the adjustment software

Changing prosthesis settings

Changing the prosthesis setting using the cockpit app

Detailed steps for changing settings via the Cockpit app.

Overview of adjustment parameters in basic mode

Overview of adjustment parameters in MyModes

Turning Bluetooth on the prosthesis on/off

Switching Bluetooth off/on using the cockpit app

How to control Bluetooth via the Cockpit app.

Querying the prosthesis status

Query status through cockpit app

Steps to check status using the Cockpit app.

Status display in the cockpit app

Interpretation of the status information displayed in the app.

Mute mode (silent mode)

Turning mute mode on/off using the Cockpit app

How to toggle mute mode via the Cockpit app.

Deep sleep mode

Turning deep sleep mode on/off using the Cockpit app

How to manage deep sleep mode via the Cockpit app.

OPG function (Optimised Physiological Gait)

MyModes

Switching MyModes with the cockpit app

How to switch between MyModes using the Cockpit app.

Switching MyModes using motion patterns

Switching from a MyMode back to basic mode

Additional operating states (modes)

Empty battery mode

How the prosthesis behaves when the battery is critically low.

Mode for charging the prosthesis

The operational state of the prosthesis during charging.

Safety mode

Overheating mode

Storage and bleeding

Storage

Guidelines for proper storage of the knee joint.

Maintenance

Identification of the product by the Service Center

How service centers identify product settings.

Legal information

Liability

Manufacturer's disclaimer and terms of liability.

Trademarks

Information regarding trademarks used in the document.

CE conformity

Details on the product's compliance with CE directives.

Local Legal Information

Technical data

Environmental conditions

Operating, storage, and transport conditions for the product.

Product

Data transfer

Tube adapter

Battery charger

Cockpit app

Torque values of the screw connections

Appendices

Operating states/error signals

Signals for operating states

Beep and vibration signals indicating operating states.

Mode switching

Signals related to switching between different operating modes.

Warnings/error signals

Error while charging the product

Error messages while establishing a connection with the cockpit app

Status signals

Electromagnetic environment

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