Otto Bock Genium X3 Instructions For Use Manual
Bionic prosthetic system
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Also See for Genium X3:
- Instructions for use manual (136 pages) ,
- Setup manual (32 pages) ,
- Reference manual (8 pages)
Related Manuals for Otto Bock Genium X3
Summary of Contents for Otto Bock Genium X3
- Page 1 Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST, Genium X3 3B5-2/3B5-2=ST Instructions for use (qualified personnel) ..............
- Page 2 Quick Reference Guide This "Quick Reference Guide" does not replace the instructions for use 7.1.2...
- Page 3 7.1.3 719R3 715H1=2 7.1.4 710D4 710D4 15Nm basic 70 mm 60 mm 40 mm...
- Page 4 7.1.8 7.1.9 5 mm 3 mm 7.1.6 Connection Job Specification Alignment Basic Mode...
- Page 5 7.1.6 Connection Job Specification Alignment Basic Mode Patient data Alignment recommendation Static Patient data Alignment recommendation Static Patient data Alignment recommendation Static 7.1.7 Connection Job Specification Alignment Basic Mode Stance phase Swing phase Functions in the gait cycle Additional functions Stance phase Swing phase Functions in the gait cycle Additional functions Stance phase Swing phase Functions in the gait cycle Stance phase Swing phase Functions in the gait cycle...
- Page 6 Symbolm Umed Readetheesectioneinetheeinstructionseforeuse Magnetic components x-Nm Tighiening iorque in ihe direciion of roiaiion and screw geomeiry Use a torque wrench Wrong Righi Use the adjustment software A successful connection between the product and the adjustment software is established Fill in the fields in the adjustment software Check the values...
- Page 7 DE | INFORMATION Zusätzlich zu der gedruckten Gebrauchsanweisung, sind auch weitere Sprachen auf CD beigelegt (siehe rückseitigen Umsch lag). Auf Anfrage können Sie eine gedruckte Gebrauchsanweisung kostenlos in der jeweiligen Landessprache unter der unten angegebenen Anschrift bestellen. EN | INFORMATION In addition to the printed Instructions for Use, additional language versions are also included on CD (see back cover).
- Page 8 TR | INFORMATION Basılmış olan kullanım kılavuzuna ilave olarak CD'de daha fazla alternatif diller bulunmaktadır (bakınız zarfın arka yüzü). İstek üzerine ilgili dilde basılmış kullanım kılavuzunu aşağıda belirtilmiş olan adresten temin edebilirsiniz. Ottobock Healthcare Products GmbH Brehmstraße 16 | 1110 Wien | Austria Service-admin.vienna@ottobock.com | Fax (+43-1) 526 79 85...
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Page 9: Table Of Contents
Table of contents Table of contents Important information for the products 3B5-X3/3B5-X3=ST and 3B5-2/3B5-2=ST ........Foreword ................................Product description ............................Design ............................... Function ............................Combination possibilities ........................2.3.1 Combination with an osseointegrated implant system ................Intended use ..............................Indications for use .......................... - Page 10 Table of contents Initial connection between cockpit app and prosthesis ................8.2.1 Starting the cockpit app for the first time ....................Control elements for cockpit app ......................8.3.1 Cockpit app navigation menu ....................... Managing components ........................8.4.1 Adding component ..........................8.4.2 Deleting a component ..........................
- Page 11 Table of contents Technical data ..............................Appendices ................................ 17.1 Symbols Used ............................ 17.2 Operating states/error signals ......................17.2.1 Signals for operating states ........................17.2.2 Warnings/error signals ........................17.2.3 Error messages while establishing a connection with the cockpit app ............17.2.4 Status signals .............................
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Page 12: Important Information For The Products 3B5-X3/3B5-X3=St And 3B5-2/3B5-2=St
Important information for the products 3B5-X3/3B5-X3=ST and 3B5-2/3B5-2=ST Important information for the products 3B5-X3/3B5-X3=ST and 3B5-2/3B5-2=ST Using the 4X350-X3 remote control is no longer possible on products with the marking "DUAL" Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 13: Foreword
Only put the product into use in accordance with the information contained in the accompanying documents sup plied. According to the manufacturer (Otto Bock Healthcare Products GmbH), the patient is the operator of the product according to the IEC 60601-1:2005/A1:2012 standard. -
Page 14: Combination Possibilities
(see page 51). Please ensure that the qualified personnel applying the product is not only authorised for fitting this knee joint, but also for the connection to the osseointegrated implant system. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 15: Intended Use
Only valid for the products 3B5-2/3B5-2=ST If the product is to be connected to an osseointegrated implant system, the qualified personnel must also be authorised for the connection to the osseointegrated implant system. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 16: Safety
► Inform the patient that the changed damping characteristics have to be verified after switching to a MyMode/basic mode. ► Ensure that the patient stands securely during all switching processes. ► To deactivate mute mode, connect and then disconnect the battery charger. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... - Page 17 ► In case of a malfunction after drying, the knee joint and AXON tube adapter must be inspected by an author ised Ottobock Service Center. ► The knee joint and the AXON tube adapter are not protected against the penetration of jets of water and steam. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST...
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Page 18: Information On The Power Supply/Battery Charging
Falling due to unexpected behaviour of the product caused by insufficient charging. ► Check the power supply unit, charger and charger cable for damage before use. ► Replace any damaged power supply unit, charger or charger cable. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 19: Battery Charger Information
► Use the product only in combination with components listed in the section "Combination possibilities" (see page 14). ► If the product is to be used in water, verify that each prosthetic component is waterproof. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... - Page 20 Insufficient insertion depth of the tube adapter Falling due to breakage of load-bearing components. ► Insert the tube adapter at least 40mm to ensure operational safety. ► The patient must be seated for length adjustments. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST...
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Page 21: Information On Proximity To Certain Areas
► Do not stack the product with other electronic devices during operation. ► If simultaneous operation cannot be avoided, monitor the product and verify proper use in the existing setup. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 22: Information On Use
► Notify the patient that resistance in the flexion and extension direction can change in case of warnings and error signals. ► Particular caution is required when carrying children down the stairs. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... - Page 23 ► If the patient participates in sports where this movement pattern can occur, configure corresponding MyModes using the adjustment software. For further information about the MyModes, see the section 'MyModes' (see page 45). Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST...
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Page 24: Notes On The Safety Modes
Improper use of the setting parameters in the MyModes Falling due to unexpected product behaviour because of changed damping behaviour. ► Instruct the patient regarding the functionality and adjustment options for all parameters of the MyModes. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 25: Scope Of Delivery And Accessories
• 1 pc. 757L16* power supply System (with threaded connector) or • 1 pc. 4E60* inductive charger • 1 pc. 3B5-X3 Genium X3 - Bionic Prosthetic System • 1 pc. cosmetic case for battery charger and power (with pyramid connector) or supply •... -
Page 26: Charging The Battery
INFORMATION When the Protective Cover is installed, the battery charger cable has to point to the upper closure. A correct knee joint charging process is only ensured with this alignment. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 27: Display Of The Current Charge Level
6.3.3 Display of the current charge level during the charging process During the charging process, the current battery charge level is indicated by the number of LEDs lit on the side of the charger. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 28: Display Of Current Charge Level Using Remote Control (Optional Accessory)
Product settings using the adjustment software can only be made via Bluetooth data transfer. For this purpose, a Bluetooth wireless connection must be established between the product and the PC using the "60X5 BionicLink Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 29: Preparing The Product To Connect To The Adjustment Software
► Apply the specified tightening torque values for installation (see the section "Technical data" see page 51). ► Observe the instructions for securing the screw connections and the use of the correct length. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 30: Bench Alignment In Alignment Apparatus
Adduction position of the socket and M-L positioning of the socket adapter (frontal plane) • Rotation position of the knee joint axis and outward rotation of the prosthetic foot (transversal plane) Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 31: Protective Cover Installation
The flexion stop can be removed to increase the flexion angle. In this case, it must be ensured that the socket and the hydraulic unit do not collide (see page 31). Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... - Page 32 When installing the screws, make sure that screws of similar type are always used on the same flexion stop. Using a cap screw and a countersunk screw together to install the flexion stop is not permitted. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST...
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Page 33: Cockpit App
2) Accept the end user license agreement (EULA) by tapping the Accept button. If the end user license agree ment (EULA) is not accepted, the Cockpit app cannot be used. → The welcome screen appears. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 34: Control Elements For Cockpit App
Mute mode is activated Connection to component has been established Connection to component has been interrupted. The app is attempt ing to re-establish the connection automatically. No existing connection to the component. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 35: Cockpit App Navigation Menu
► Delete the component from the Cockpit app if applicable (see the section "Deleting a component") ► Add the component again in the Cockpit app (see the section "Adding a component") Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 36: Deleting A Component
The joint is fixed in the flexion direction. This function must be enabled in the adjustment software. Once the function is enabled, you can also choose between an intuitive and a conscious lock. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 37: Walking
3) Move the buttocks in the direction of the back support and lean the upper body forward. INFORMATION: Resistance while sitting down can be changed with the Cockpit app via the parameter “Resistance” (see page 41). Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 38: Sitting
9.1.7 Walking up stairs step-over-step INFORMATION To use this function, it needs to be enabled in the adjustment software. It also has to be activated using the Cock pit app (see page 41). Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 39: Overcoming Obstacles
3) Quickly flex the hip. This causes the knee to flex. 4) With the knee flexed, step over the obstacle. With sufficient knee flexion, the extension resistance is increased to allow enough time for crossing the obstacle. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 40: Walking Down Stairs
(e.g. while becoming accustomed to the prosthesis). The O&P professional can use the adjustment software to track these changes at the patient’s next appointment. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 41: Changing The Prosthesis Setting Using The Cockpit App
Activation/deactivation of the sitting function. Activated 1 - activated For switching with the Cockpit app, this func tion has to be activated in the adjustment software. Further information (see page 38). Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 42: Overview Of Adjustment Parameters In Mymodes
Volume of beep signal for confirmation tones (e.g. when checking the charge level, switch ing MyModes). The "0" setting deactivates the audible feedback signals. However, warning signals are still generated if errors occur. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 43: Turning Bluetooth On The Prosthesis On/Off
Connecting the battery charger automatically deactivates mute mode again. 9.5.1 Turning mute mode on/off using the Cockpit app 1) When the component is connected, tap the symbol in the main menu. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 44: Deep Sleep Mode
DSC ensures the knee will not release stance resistance during biomechanically unstable static and dynamic con ditions. Constantly checking multiple parameters, DSC ensures the optimally timed decision for the knee to safely Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 45: Mymodes
Bluetooth is then turned on for approx. 2 minutes. During this time, the app must be started and used to establish a connection. If required, Bluetooth on the prosthesis can be switched on permanently afterwards (see page 43). Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 46: Switching Mymodes Using Motion Patterns
à MyMode 1 2x à MyMode 1 4x à MyMode 2 3x à MyMode 2 MyMode 1 ð ð ð ð þ ð MyMode 2 1) Position the prosthetic leg back slightly. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 47: Switching From A Mymode Back To Basic Mode
Beeps and vibration signals are emitted if the available battery charge level is 5% (see page 55). During this time, damping settings are set to their safety mode values. This may be low or high depending on the setting in the Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 48: Mode For Charging The Prosthesis
Before storing the knee joint, the knee head has to be extended. The knee head must not be flexed! • Avoid extended disuse of the product (use the product regularly). Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 49: Cleaning
► The prosthesis settings (parameters) have to be checked using the corresponding adjustment software and changed as needed. 15 Legal information All legal conditions are subject to the respective national laws of the country of use and may vary accordingly. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 50: Liability
15.3 CE conformity Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with European require ments for medical devices. The full text of the regulations and requirements is available at the following Internet address: http://www.ottobock.com/conformity... -
Page 51: Technical Data
Maximum time: 1 hour Water resistance Waterproof, corrosion-resistant Prox. system height to alignment reference point 3B5-3* 0 mm (pyramid adapter) Prox. system height up to alignment reference point 26 mm 3B5-3=ST* (threaded connector) Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... - Page 52 90 % relative humidity, non-condensing Input voltage 100 V~ to 240 V~ Mains frequency 50 Hz to 60 Hz Output voltage 12 V Battery charger Reference number 4E60* Storage and transport in original packaging -25 °C to 70 °C/-13 °F to 158 °F Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST...
- Page 53 Tube clamp of the knee joint 7 Nm / 62 lbf. In. Proximal prosthesis components with pyramid receiver 15 Nm / 133 lbf. In. Proximal prosthesis components with threaded connect 10 Nm / 89 lbf. In. Flexion stop 0.6 Nm / 5 lbf. In. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST...
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Page 54: Appendices
WW – week of manufacture NNN – sequential number Lot number (PPPP YYYY WW) PPPP – plant YYYY – year of manufacture WW – week of manufacture Caution, hot surface Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 55: Operating States/Error Signals
– 3 x long Charge level under 25% Charge battery soon. Remaining operating time approx. 24 hours – 5 x long Charge level under 10% Charge battery soon Remaining operating time approx. 6 hours Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... - Page 56 If the dis tance is more than 2 mm, the prosthesis cannot be charged. Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST...
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Page 57: Error Messages While Establishing A Connection With The Cockpit App
• Hold the component with the sole of the foot facing up to make the component "visible" for 2 minutes. • If multiple components were stored, was the correct component selected? Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 58: Status Signals
During the charging process, the current battery charge level is indicated by the number of LEDs lit on the side of the charger. LEDs Battery charge 0%-10% 10%-30% 30%-50% 50%-70% 70%-90% >90% level Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST,Ge nium X3 3B5-2/3B5-2=ST... -
Page 59: Directives And Manufacturer's Declaration
Directives and manufacturer's declaration – electromagnetic interference The product 'Genium X3 - Bionic Prosthetic System 3B5-X3 / Genium X3 3B5-2' is designed for operation in an electromagnetic environment as specified below. The customer or user of the product 'Genium X3 - Bionic Pros... - Page 60 Directives and manufacturer's declaration – electromagnetic interference immunity The product 'Genium X3 - Bionic Prosthetic System 3B5-X3 / Genium X3 3B5-2' is designed for operation in an electromagnetic environment as specified below. The customer or user of the product 'Genium X3 - Bionic Pros...
- Page 61 A site survey is recommended to establish the electromagnetic conditions as a result of sta tionary HF transmitters. If the field strength determined at the site of the product 'Genium X3 - Bionic Prosthetic System 3B5-X3 / Genium X3 3B5-2' exceeds the compliance level specified above, the product 'Genium X3 - Bionic Prosthetic System 3B5-X3 / Genium X3 3B5-2' has to be monitored in regards to normal operation at each place of use.
- Page 62 HF telecommunication equipment and the product 'Genium X3 - Bionic Prosthetic System 3B5-X3 / Genium X3 3B5-2' The product 'Genium X3 - Bionic Prosthetic System 3B5-X3 / Genium X3 3B5-2' is designed for operation in an electromagnetic environment where HF interference is monitored. The customer or user of the product 'Genium X3 - Bionic Prosthetic System 3B5-X3 / Genium X3 3B5-2' can help prevent electromagnetic interference by com...
- Page 64 EP 2772232 in DE, GB, FR, IT, NL, SE, TR, IS Patents pending in Brazil, Germany and USA Otto Bock Healthcare Products GmbH Brehmstraße 16 · 1110 Wien · Austria T +43-1 523 37 86 · F +43-1 523 22 64...