Otto Bock Genium X3 3B5-3 Instructions For Use Manual
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Summary of Contents for Otto Bock Genium X3 3B5-3
- Page 1 Genium X3 3B5-3/3B5-3=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 Genium X3 3B5-3/3B5-3=ST...
- Page 3 7.1.3 715H1=2 719R3 7.1.4 710D4 710D4 15Nm basic 70 mm 60 mm 40 mm Genium X3 3B5-3/3B5-3=ST...
- Page 4 7.1.8 7.1.9 5 mm 3 mm 7.1.6 Alignment Connection Job Specification Basic Mode Genium X3 3B5-3/3B5-3=ST...
- Page 5 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 Additional functions Additional functions 7.1.9 5 mm 3 mm Genium X3 3B5-3/3B5-3=ST...
- Page 6 Tightening torque in the direction of rotation and screw geometry Use a torque wrench Wrong Right 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 Genium X3 3B5-3/3B5-3=ST...
- Page 7 HR | INFORMACIJA Dodatno uz tiskane upute za uporabu priloženi su i drugi jezici na CD-u (vidi poleđinu). Na upit možete na dolje navedenoj adresi besplatno naručiti tiskane upute za uporabu na dotičnom jeziku. Genium X3 3B5-3/3B5-3=ST...
- Page 8 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 3B5-3/3B5-3=ST...
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Page 9: Table Of Contents
............................Cockpit app ................................ System Requirements .......................... 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 ....................... Genium X3 3B5-3/3B5-3=ST... - Page 10 Storage and bleeding ............................Cleaning ................................Maintenance ..............................14.1 Identification of the product by the Service Center .................. Legal information .............................. 15.1 Liability .............................. 15.2 Trademarks ............................15.3 CE conformity ............................. 15.4 Local Legal Information ........................Technical data ..............................Genium X3 3B5-3/3B5-3=ST...
- Page 11 ......................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 ............................. 17.3 Directives and manufacturer’s declaration ....................17.3.1 Electromagnetic environment ........................ Genium X3 3B5-3/3B5-3=ST...
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Page 12: Foreword
(see Page 45). 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 45). Genium X3 3B5-3/3B5-3=ST... -
Page 13: Combination Possibilities
(see Page 48). 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 3B5-3/3B5-3=ST... -
Page 14: Application
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 3B5-3/3B5-3=ST... -
Page 15: 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 3B5-3/3B5-3=ST... - Page 16 ► 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 steam. Genium X3 3B5-3/3B5-3=ST...
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Page 17: 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 3B5-3/3B5-3=ST... -
Page 18: Battery Charger Information
► Clean the threads before every installation. ► Apply the specified tightening torque values for installation (see the section "Technical data"). ► Observe the instructions for securing the screw connections and the use of the correct length. Genium X3 3B5-3/3B5-3=ST... - Page 19 (with the help of soft padding on the socket). CAUTION 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 3B5-3/3B5-3=ST...
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Page 20: Information On Proximity To Certain Areas
► Ensure that the patient is not in the vicinity of sources of strong magnetic and electrical interference during tri al fitting (such as theft prevention systems, metal detectors...). If this cannot be avoided, ensure at least that the patient has a safeguard when walking or standing (e.g. a handrail or the support of another person). Genium X3 3B5-3/3B5-3=ST... -
Page 21: Information On Use
► If the activity level is not reduced in spite of the pulsating vibration signals, this could lead to the hydraulic ele ment overheating and, in extreme cases, cause damage to the product. In this case, the product should be inspected by an authorised Ottobock Service Centre. Genium X3 3B5-3/3B5-3=ST... -
Page 22: Notes On The Safety Modes
Safety mode cannot be activated due to malfunction caused by water penetration or mechanical damage Falling due to unexpected product behaviour because of changed damping behaviour. ► Using the product when it is defective is prohibited. ► The product must be inspected by an authorised Ottobock Service Centre. Genium X3 3B5-3/3B5-3=ST... -
Page 23: Instructions For Use With An Osseointegrated Implant System
► Inform the patient that the changed damping characteristics have to be verified after switching, and feedback from the acoustic signal emitter and the device display must be observed. ► Switching back to basic mode is mandatory once the activities in MyMode have been completed. Genium X3 3B5-3/3B5-3=ST... -
Page 24: Scope Of Delivery And Accessories
Use the 757L16* power supply and 4E60* battery charger to charge the battery. • Note the permissible temperature range for charging the battery (see Page 48). • The distance between the battery charger and the receiver on the product must not exceed 2 mm. Genium X3 3B5-3/3B5-3=ST... -
Page 25: Connecting The Power Supply And Battery Charger
6.3 Display of the current charge level 6.3.1 Display of battery charge level without additional devices INFORMATION The charge level cannot be displayed during the charging process, e.g. by turning the prosthesis over. The product is in charging mode. Genium X3 3B5-3/3B5-3=ST... -
Page 26: Display Of The Current Charge Level Using The Cockpit App
Ensure that possible flexion or adduction of the transfemoral residual limb can be compensated to a permissible extent by an adapter approved by the implant manufacturer in the course of static alignment optimisation. Safe functioning of the knee joint is only guaranteed with biomechanically correct alignment. Genium X3 3B5-3/3B5-3=ST... -
Page 27: Settings With The "X-Soft" Adjustment Software
3) Fasten the two closures after removing the Protective Cover. 7.1.3 Shortening the Tube Adapter CAUTION Incorrect processing of tube Falling due to damage to the tube. ► Do not clamp the tube into a vice. ► For shortening the tube, use only a tube cutter. Genium X3 3B5-3/3B5-3=ST... -
Page 28: Installing The Tube Adapter
Static alignment in the alignment apparatus must always be carried out without shoes, otherwise a correct • adjustment will not be possible. Static alignment with the LaserLine/plumb line must be carried out with shoes, otherwise a correct adjust • ment will not be possible. Genium X3 3B5-3/3B5-3=ST... -
Page 29: Static Alignment Optimisation
2) Check the available distance between the hydraulics and socket. It must be at least 3 mm. INFORMATION: If the distance is less, a flexion stop has to be installed or an existing flexion stop replaced with a larger one. For information on the flexion stop, see the next section. Genium X3 3B5-3/3B5-3=ST... -
Page 30: Flexion Stop
The Cockpit app can be downloaded free of charge from the respective online store. For more information, please visit the website: http://www.ottobock.com/cockpitapp. To download the Cockpit app, the QR code on the supplied Bluetooth PIN card can be read with the mobile device (requirement: QR code reader and camera). Genium X3 3B5-3/3B5-3=ST... -
Page 31: System Requirements
Then the main menu appears with the name of the connected component. INFORMATION After the initial connection to the component has been established successfully, the app will connect automatically each time it is started. No further steps are required. Genium X3 3B5-3/3B5-3=ST... -
Page 32: Control Elements For Cockpit App
Change settings of the currently selected mode (see Page 37) Status Status General Query status of the connected component (see Page 40) Manage components Manage components Add or delete components (see Page 33) Imprint/Info Imprint/Info Display information/legal notices for the cockpit app Genium X3 3B5-3/3B5-3=ST... -
Page 33: Managing Components
The connection for a component can be stored on more than one device. However, only one device can be con nected to the component at one time. If there is an existing connection between the component and a different device, the following information appears while the connection is being established with the current device: Genium X3 3B5-3/3B5-3=ST... -
Page 34: Use
3) Do not change the knee angle for a brief period (1/8 second). This time period prevents unintentional activation of the standing function. → The blocked joint can now be fully loaded in the flexion direction. Deliberate unlocking of the joint ► By deliberately extending or unloading the knee joint, is it unlocked again. Genium X3 3B5-3/3B5-3=ST... -
Page 35: Walking
9.1.5.1 Sitting function 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 38). Genium X3 3B5-3/3B5-3=ST... -
Page 36: Standing Up
7) You can climb the next step or continue walking normally. 9.1.8 Overcoming obstacles 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 38). Genium X3 3B5-3/3B5-3=ST... -
Page 37: Walking Down Stairs
If Bluetooth is switched off, it can be turned on by turning the prosthesis upside-down or by connecting/discon necting the battery charger. Bluetooth is then turned on for approx. 2 minutes. The connection must be estab lished during this period. Genium X3 3B5-3/3B5-3=ST... -
Page 38: Changing The Prosthesis Setting Using The Cockpit App
Setting range, Meaning ware range Resistance 120 – 180 +/- 10 Resistance against flexion motion e.g. when walking down stairs or when sitting down Angle 55° – 70° +/- 3° Maximum flexion angle in the swing phase Genium X3 3B5-3/3B5-3=ST... -
Page 39: Overview Of Adjustment Parameters In Mymodes
This makes extension of the joint possible independently of the settings for the paramet ers "Basic ext." and "Locking angle". This may be necessary to switch to basic mode using a movement pattern. Pitch 1000 Hz–4000 Hz 1000 Hz–4000 Hz Pitch of beep signal for confirmation tones Genium X3 3B5-3/3B5-3=ST... -
Page 40: Turning Bluetooth On The Prosthesis On/Off
Display of the next maintenance date For informational purposes only Batt. Current prosthesis charge level, as a For informational purposes only percentage Stb/Act: 58/29 Estimated remaining operating time For informational purposes only of prosthesis in hours. Rest mode (Stb) e.g. 58 hours, active use (Act) e.g. 29 hours Genium X3 3B5-3/3B5-3=ST... -
Page 41: Mute Mode (Silent Mode)
This function enables the following features: PreFlex PreFlex ensures the knee is in 4° of flexion at the end of swing phase in preparation for loading response. This makes initiating stance phase flexion easier and forward movement is less restricted. Genium X3 3B5-3/3B5-3=ST... -
Page 42: Mymodes
1C61 Triton Vertical Shock. For details on assembly and alignment please refer to the instructions for use of the foot. Feet without axial compression are generally not suited for running. Genium X3 3B5-3/3B5-3=ST... -
Page 43: Switching Mymodes With The Cockpit App
Position the prosthetic leg back slightly and bounce on the forefoot with the leg extended while maintaining constant contact with the floor. • Weight must be placed on the forefoot while bouncing. • The load may not be taken off the foot fully when relieving the load. Genium X3 3B5-3/3B5-3=ST... -
Page 44: Switching From A Mymode Back To Basic Mode
(silent mode) is activated. For more information about mute mode, see the section "Mute mode" (see Page 41). 4) After the beep and vibration signal sounds, keep the prosthetic leg extended and still for 1 second. Genium X3 3B5-3/3B5-3=ST... -
Page 45: Additional Operating States (Modes)
Overheating mode is indicated by a long vibration every 5 seconds. The following functions are deactivated in overheating mode: • Sitting function • Display of the battery charge level without additional equipment • Switching to a MyMode Genium X3 3B5-3/3B5-3=ST... -
Page 46: Storage And Bleeding
Use of the prosthesis with incorrect setting data Falling due to unexpected prosthesis behaviour caused by triggering the swing phase at the wrong time. ► The prosthesis settings (parameters) have to be checked using the corresponding adjustment software and changed as needed. Genium X3 3B5-3/3B5-3=ST... -
Page 47: Legal Information
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 48: 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 49 Storage and transport in original packaging -40 °C/-40 °F to +70 °C/+158 °F Storage and transport without packaging -40 °C/-40 °F to +70 °C/+158 °F 10 % to 93 % relative humidity, non-condensing Operation 0 °C/+32 °F to +40 °C/+104 °F max. 90 % relative humidity, non-condensing Input voltage 100 V~ to 240 V~ Mains frequency 50 Hz to 60 Hz Genium X3 3B5-3/3B5-3=ST...
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Page 50: Appendices
Compliance with the requirements according to "FCC Part 15" (USA) Compliance with the requirements under the "Radiocommunications Act" (AUS) Non-ionising radiation Protection against penetration of solid foreign objects with a diameter greater than 1 mm, no pro tection against water Dust-proof, protected against strong jets of water Genium X3 3B5-3/3B5-3=ST... -
Page 51: Operating States/Error Signals
If the Volume parameter is set to '0' in the Cockpit app, there are no beep signals (see Page 37). Beep signal Vibration sig Additional action performed Event 1x short 1x short Mode switching using the Cockpit Mode switching is performed using the Cockpit app. Genium X3 3B5-3/3B5-3=ST... -
Page 52: Warnings/Error Signals
Safety If the error persists, use of the mode active or undeter product is prohibited. The mined valve state. product must be inspected by Undetermined product an authorised Ottobock Ser behaviour. vice Center. Genium X3 3B5-3/3B5-3=ST... - Page 53 Defective battery charger. If the error persists, the bat tery charger and power sup ply must be inspected by an authorised Ottobock Ser vice Center. Genium X3 3B5-3/3B5-3=ST...
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Page 54: 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 3B5-3/3B5-3=ST... -
Page 55: Directives And Manufacturer's Declaration
Electrostatic discharge IEC 61000-4-2 ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air, High frequency electro IEC 61000-4-3 3 V/m 10 V/m magnetic fields 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz 80 % AM at 1 kHz 80 % AM at 1 kHz Genium X3 3B5-3/3B5-3=ST... - Page 56 TETRA 400 Pulse modula tion 18 Hz 430 to 470 GMRS 460, FRS 460 ± 5 kHz devi ation 1 kHz sine 704 to 787 LTE band 13, Pulse modula tion 217 Hz 800 to 960 GSM 800/900, Pulse modula tion TETRA 800, 18 Hz iDEN 820, CDMA 850, GSM 800/900, LTE Band 5 Genium X3 3B5-3/3B5-3=ST...
- Page 57 1845 217 Hz GSM 1900; 1970 DECT; LTE Band 1, 3, 4, 25; UMTS 2450 2400 to 2570 Bluetooth Pulse modula tion WLAN 802.11 217 Hz b/g/n, RFID 2450 LTE band 7 5240 5100 to 5800 WLAN 802.11 Pulse modula a/n tion 5500 217 Hz 5785 Genium X3 3B5-3/3B5-3=ST...
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- Page 59 Genium X3 3B5-3/3B5-3=ST...
- Page 60 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...