Otto Bock Genium X3 3B5-2 Instructions For Use Manual
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Summary of Contents for Otto Bock Genium X3 3B5-2
- Page 1 Genium X3 3B5-2/3B5-2=ST Instructions for use (qualified personnel) ..............
- Page 2 HR | INFORMACIJA Dodatno uz tiskane upute za uporabu priloženi su i drugi jezici na CD-u (vidi poleđinu). Na upit možete na dolje navedenoj adre si besplatno naručiti tiskane upute za uporabu na dotičnom jeziku. Genium X3 3B5-2/3B5-2=ST...
- Page 3 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 Genium X3 3B5-2/3B5-2=ST...
- Page 4 Genium X3 3B5-2/3B5-2=ST...
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Page 5: Table Of Contents
....................8.1.8 Checking the socket after bench alignment .................... 8.1.9 Flexion stop ............................Cockpit app ................................ System Requirements .......................... Initial connection between cockpit app and prosthesis ................9.2.1 Starting the cockpit app for the first time ....................Genium X3 3B5-2/3B5-2=ST... - Page 6 Safety mode ............................12.4 Overheating mode ..........................Storage and bleeding ............................Cleaning ................................Maintenance ..............................15.1 Identification of the product by the Service Center .................. Legal information .............................. 16.1 Liability .............................. 16.2 Trademarks ............................16.3 CE Conformity ............................ Genium X3 3B5-2/3B5-2=ST...
- Page 7 Appendices ................................ 18.1 Symbols Used ............................ 18.2 Operating states/error signals ......................18.2.1 Signals for operating states ........................18.2.2 Warnings/error signals ........................18.2.3 Error messages while establishing a connection with the cockpit app ............18.2.4 Status signals ............................. Genium X3 3B5-2/3B5-2=ST...
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Page 8: Important Information
keys to select the RC version: 1.0.0.4 menu option. If an older version appears than 1.0.0.6, ► Use the the remote control must be updated by an authorised Ottobock Service Centre. The function of the remote control with this or the updated knee joint is only possible with version 1.0.0.6 or higher. Genium X3 3B5-2/3B5-2=ST... -
Page 9: Foreword
(see Page 43). Empty battery mode permits safe walking when the battery is drained. Resistance parameters that are predefined by the product are configured for this purpose (see Page 42). Genium X3 3B5-2/3B5-2=ST... -
Page 10: Combination Possibilities
4 Application 4.1 Indications for use The product is to be used solely for lower limb exoprosthetic fittings. 4.2 Area of application Area of application according to Ottobock’s MOBIS classification: Genium X3 3B5-2/3B5-2=ST... -
Page 11: Conditions Of Use
The product may be fitted only by qualified personnel authorised by Ottobock after completing the corresponding training. 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 3B5-2/3B5-2=ST... -
Page 12: 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 3B5-2/3B5-2=ST... - Page 13 ► 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 3B5-2/3B5-2=ST...
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Page 14: 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 3B5-2/3B5-2=ST... -
Page 15: Battery Charger Information
Falling due to breakage or loosening of the screw connections. ► Clean the threads before every installation. ► Apply the specified installation torque values. ► Observe the instructions for securing the screw connections and the use of the correct length. Genium X3 3B5-2/3B5-2=ST... - Page 16 ► If the patient uses walking aids (e.g. crutches or walking canes) during the adjustment process, readjustment is required as soon as the patient stops using these walking aids. ► Use the online help which is integrated into the software. ► Do not pass on your personal access data. Genium X3 3B5-2/3B5-2=ST...
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Page 17: Information On Proximity To Certain Areas
► Inform the patient that the handrail always has to be used when walking up stairs, and that most of the sole of the foot has to be set onto the stair surface. ► Particular caution is required when carrying children up the stairs. Genium X3 3B5-2/3B5-2=ST... - Page 18 ► Make sure that the patient is standing safely when using the stance function and checks the lock of the knee joint before placing his/her full weight on the prosthesis. ► Inform the patient whether and in what way the stance function was configured in the adjustment software. Information on the stance function see Page 30. Genium X3 3B5-2/3B5-2=ST...
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Page 19: Notes On The Safety Modes
Improper use of the device Falling due to altered damping behaviour as a result of unexpected switching into MyMode. ► Use the instructions for use (user) to instruct the patient on proper use of the device with the cockpit app. Genium X3 3B5-2/3B5-2=ST... -
Page 20: Scope Of Delivery And Accessories
Genium X3 Protective Cover: 4X900 • 4X350-X3 remote control The user interface is available in the following lan • Genium X3 Protective Cover: 4X193-1 guages: German, English, French, Italian, Spanish, • X3 – flexion stop 22.5°: 4H104 Dutch, Swedish Genium X3 3B5-2/3B5-2=ST... -
Page 21: Charging The Battery
3) After the charging process is complete, hold the prosthesis still and remove the inductive charger from the receiver. → A self-test is performed. The joint is operational only after corresponding feedback (see Page 51). Genium X3 3B5-2/3B5-2=ST... -
Page 22: Display Of The Current Charge Level
7.3.4 Display of the current charge level during the charging process During the charging process, the current battery charge level is indicated by the LEDs lit on the side of the char ger. Quantity Battery charge level 0%-10% 10%-30% 30%-50% 50%-70% 70%-90% > 90% Genium X3 3B5-2/3B5-2=ST... -
Page 23: Preparation For Use
2 minutes after connecting/disconnecting the battery charger and is then turned off again automatically. When a connection with the PC is active (the symbol is lit up), the Bluetooth function is not switched off automatically. Genium X3 3B5-2/3B5-2=ST... -
Page 24: Shortening The Tube Adapter
A calibrated alignment recommendation for prosthesis bench alignment is provided in the adjustment software for the individual conditions of the prosthesis and patient. Therefore, consult the adjustment software for the alignment data. The following points must be observed during alignment: Genium X3 3B5-2/3B5-2=ST... -
Page 25: Static Alignment Optimisation
After bench alignment, verify that at maximum extension and maximum flexion the distance from the socket to the knee joint is not less than the minimum. A collision of the socket with the hydraulics or frame can cause damage to the knee joint. Genium X3 3B5-2/3B5-2=ST... -
Page 26: Flexion Stop
INFORMATION: Do not insert the screws without the flexion stop! Inserting the flexion stop 1) Insert the flexion stop. 2) Secure the screws with 636K13 thread lock. 3) Insert the screws. 4) Tighten the screws to 0.6 Nm with the 710D17 torque wrench. Genium X3 3B5-2/3B5-2=ST... -
Page 27: 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. 3) Tap the Add component button. Genium X3 3B5-2/3B5-2=ST... -
Page 28: Control Elements For Cockpit App
7. Display and name of the currently selected mode (e.g. 1. Basic Mode) Mute mode is activated 100% 1. Basic Mode Connection to component has been established Connection to component has been interrupted. The app is attempt ing to re-establish the connection automatically. Genium X3 3B5-2/3B5-2=ST... -
Page 29: Cockpit App Navigation Menu
5) After the PIN code is entered, a connection to the component is established. → While the connection is being established, 3 beep signals sound and the symbol appears. symbol is displayed when the connection has been established. Genium X3 3B5-2/3B5-2=ST... -
Page 30: 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 3B5-2/3B5-2=ST... -
Page 31: Walking
3) Move the buttocks in the direction of the backrest and lean the upper body forward. INFORMATION: Resistance while sitting down can be changed with the Cockpit app or the remote control via the parameter "Resistance" (see Page 35). Genium X3 3B5-2/3B5-2=ST... -
Page 32: Sitting
4) Stand up with support from the hands while keeping weight evenly distributed on feet. 10.1.7 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 or remote control (see Page 35). Genium X3 3B5-2/3B5-2=ST... -
Page 33: 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 3B5-2/3B5-2=ST... -
Page 34: Walking Down Stairs
(e.g. as they become accustomed to the prosthesis). The prosthetist can use the adjustment software to trace these changes at the patient's next appointment. • If the settings of a MyMode are to be modified, one must first switch to this MyMode. Genium X3 3B5-2/3B5-2=ST... -
Page 35: Changing The Prosthesis Setting Using The Cockpit App
Sitting function Deactivated 0 - deactivated Activation/deactivation of the sitting function. Activated 1 - activated For switching with the Cockpit app or remote control, this function has to be activated in the adjustment software. Further information (see Page 32). Genium X3 3B5-2/3B5-2=ST... -
Page 36: Overview Of Adjustment Parameters In Mymodes
0 – 4 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 in case of errors are still gen erated. Genium X3 3B5-2/3B5-2=ST... -
Page 37: Turning Bluetooth On The Prosthesis On/Off
Reset the counter by using the key (Steps with the prosthesis side) to confirm the menu option Step Total step counter For informational purposes only (Steps with the prosthesis side) Batt. Current prosthesis charge level, as a For informational purposes only percentage Genium X3 3B5-2/3B5-2=ST... -
Page 38: Mute Mode (Silent Mode)
10.6.1 Turning deep sleep mode on/off using the Cockpit app Activating deep sleep mode 1) When the component is connected, tap the symbol in the main menu. → The navigation menu opens. 2) In the navigation menu, tap the entry "Functions". Genium X3 3B5-2/3B5-2=ST... -
Page 39: Turning Deep Sleep Mode On/Off Using The Remote Control
The flexed and partially loaded knee will also disable the stance phase on slopes and ramps to allow for greater knee flexion and more ground clearance in the swing phase. Genium X3 3B5-2/3B5-2=ST... -
Page 40: Mymodes
If the Volume parameter is set to '0' in the Cockpit app or using the remote control (see Page 34) or if mute mode (silent mode) is activated, there are no beep signals. Once a connection to a prosthesis has been established, the cockpit app can be used to switch between the MyModes. Genium X3 3B5-2/3B5-2=ST... -
Page 41: Switching Mymodes Using Motion Patterns
INFORMATION: If this beep and vibration signal does not sound, the requirements were not observed when bouncing the foot or mute mode (silent mode) is activated. For more information about mute mode, see the section "Mute mode" (see Page 38). Genium X3 3B5-2/3B5-2=ST... -
Page 42: Switching From A Mymode Back To Basic Mode
(mode 1) from empty battery mode by charging the product. 12.2 Mode for charging the prosthesis The product is non-functional during charging. The product is set to safety mode damping. This may be low or high depending on the setting in the adjustment software. Genium X3 3B5-2/3B5-2=ST... -
Page 43: Safety Mode
Avoid extended disuse of the product (use the product regularly). 14 Cleaning 1) Rinse the product with clear fresh water. 2) Dry the product with a soft cloth. 3) Allow to air dry in order to remove residual moisture. Genium X3 3B5-2/3B5-2=ST... -
Page 44: Maintenance
All product names mentioned in this document are subject without restriction to the respective applicable trade mark laws and are the property of the respective owners. All brands, trade names or company names may be registered trademarks and are the property of the respective owners. Genium X3 3B5-2/3B5-2=ST... -
Page 45: Ce Conformity
Caution: Exposure to Radio Frequency Radiation. This device must not be co-located or operating in conjunction with any other antenna or transmitter. Responsible party: Otto Bock Health Care, LP 3820 West Great Lakes Drive Salt Lake City, Utah 84120-7205 USA... -
Page 46: Technical Data
RF field in excess of Health Canada limits for the general population; consult Safety Code 6, obtainable from Health Canada’s website http://www.hc-sc.gc.ca/rpb. Responsible party: Otto Bock Healthcare Canada Ltd. 5470 Harvester Road L7L 5N5 Burlington, Ontario Canada Phone + 1-800-665-3327 Caution: Federal law (USA) restricts this device to sale by or on the order of a practitioner licensed by law of the State in which he/she practices to use or order the use of the device. - Page 47 Storage and transport without packaging -25 °C to 70 °C/-13 °F to 158 °F Max. 93% relative humidity, non-condensing Operation 5 °C to 40 °C/41 °F to 104 °F Max. 93% relative humidity, non-condensing Protection rating IP40 Input voltage 12 V Cockpit app Article number Cockpit 4X441-Andr=V* Genium X3 3B5-2/3B5-2=ST...
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Page 48: Appendices
Please observe the instructions of your national authority pertaining to return and collection. Declaration of conformity according to the applicable European directives Serial number Lot number Caution, hot surface Protect from moisture Please note the instructions for use Genium X3 3B5-2/3B5-2=ST... -
Page 49: Operating States/Error Signals
The change in flexion resist safety mode activation ance has to be noted. The product must be inspec e.g. a sensor is not oper ted immediately by an author ational ised Ottobock Service Center. Switch to safety mode (see Page 43). Genium X3 3B5-2/3B5-2=ST... - Page 50 LED 3 is lit up The prosthesis is not being Connection charged improved by reducing the distance between the char Distance between battery ger and receiver of the char charger and receiver of the ging unit. charging unit too great. Genium X3 3B5-2/3B5-2=ST...
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Page 51: Error Messages While Establishing A Connection With The Cockpit App
This display turns off automatically after approximately one minute to avoid bother some light at night. The charging process is not affected. Battery charger disconnected Beep sig Vibration Event Resolution signal 1x short 1x short Self-test completed successfully. Product is operational. Genium X3 3B5-2/3B5-2=ST... - Page 52 Battery charge level During the charging process, the current battery charge level is indicated by the LEDs lit on the side of the char ger. LEDs Battery charge 0%-10% 11%-30% 31%-50% 51%-70% 71%-90% >90% level Genium X3 3B5-2/3B5-2=ST...
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- Page 55 Genium X3 3B5-2/3B5-2=ST...
- Page 56 EP 2498730 in DE, FR, GB Patents pending in Australia, Brazil, Canada, China, EPA, Germany, India, Japan, Russia, Taiwan and USA. Otto Bock Healthcare Products GmbH Brehmstraße 16 · 1110 Wien · Austria T +43-1 523 37 86 · F +43-1 523 22 64...