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Otto Bock Genium X3 3B5-3-ST Instructions For Use Manual
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Otto Bock Genium X3 3B5-3-ST Instructions For Use Manual

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Genium X3 3B5-3 / 3B5-3=ST
Instructions for use (user) ...............................................................................................
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Florian Sylvain
April 11, 2025

Bonjour j’ai un problème avec genium x3 pour le charge je vais du Québec présentement en république la lumière mauve allume et les petits lumières verte sur le côté aussi mais pas de chargé après plus d’une heure et le x3vibre5foistoutles minutes

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1 comments:
Mr. Anderson
April 11, 2025

If your Otto Bock Genium X3 3B5-3-ST is not charging and shows a purple light along with green lights, take the following steps:

1. Check if the country-specific plug adapter is fully engaged on the power supply.
2. Test the wall socket with another electric appliance to ensure the socket is working.
3. Verify that the charging cable plug is fully engaged on the battery charger.
4. If the issue persists, the power supply or battery charger may be defective and must be inspected by an authorized Ottobock Service Center.

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Summary of Contents for Otto Bock Genium X3 3B5-3-ST

  • Page 1 Genium X3 3B5-3 / 3B5-3=ST Instructions for use (user) ....................
  • Page 2 order-ifu@ottobock.com Documentu 647H47 Versionu 08 SCAN ME httpsu//product-documents.ottobock.com/IFU/INT/3B5-3/647H47/08/O/S/F DE | Lassen Sie sich durch das Fachpersonal in den sicheren Gebrauch des Produkts einweisen. Weitere Sprachen dieser Gebrauchsanweisung sind online verfügbar oder können kostenlos als gedrucktes Exemplar bestellt werden (siehe Seite 2). EN | Consult qualified personnel for instructions on how to use the product safely.
  • Page 3 NO | La fagpersonell instruerer deg i sikker bruk av produktet. Flere språk for denne bruksanvisningen er tilgjengelige på nett, eller de kan bestilles som utskrevet eksemplar (se side 2). FI | Anna ammattihenkilöstön perehdyttää itsesi tuotteen turvalliseen käyttöön. Tämän käyttöohjeen muut kielet ovat saatavilla online tai niitä voi tilata maksutta painettuna versiona (katso sivu 2).

  • Page 4: Product Description

    English 1 Foreword INFORMATION Date of last update: 2024-01-03 Please read this document carefully before using the product and observe the safety ► notices. Obtain instruction from the qualified personnel in the safe use of the product. ► Please contact the qualified personnel if you have questions about the product or in case of ►...
  • Page 5 The microprocessor uses the measurements of an integrated sensor system as a basis to control a hydraulic unit that influences the damping behaviour of the product. These sensor data are updated and evaluated 100 times per second. As a result, the behaviour of the product is adapted to the current motion situation (gait phase) dynamically and in real time.
  • Page 6 3.4 Contraindications 3.4.1 Absolute Contraindications • Body weight over 150 kg 3.5 Qualification 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.
  • Page 7 WARNING Use of damaged power supply unit, adapter plug or battery charger Risk of electric shock due to contact with exposed, live components. ► Do not open the power supply unit, adapter plug or battery charger. Do not expose the power supply unit, adapter plug or battery charger to extreme loading ►...
  • Page 8 CAUTION Use of the product when battery charge level is too low Falling due to unexpected behaviour of the prosthesis because of changed damping behaviour. ► Check the current charge level before use and charge the prosthesis if required. Note that the operating time of the product may be reduced at low ambient temperatures or ►...
  • Page 9 CAUTION Signs of wear and tear on the product components Falling due to damage or malfunction of the product. ► Regular service inspections (maintenance) are mandatory in the interest of your own safety and in order to maintain operating reliability and protect the warranty. CAUTION Use of unapproved accessories >...
  • Page 10 4.5 Battery charger information WARNING Storing/transporting the product near active implanted systems Interference with active implantable systems (e.g. pacemaker, defibrillator, etc.) due to the product's magnetic field. When storing/transporting the product in the immediate vicinity of active implantable sys­ ► tems, ensure that the minimum distances stipulated by the manufacturer of the implant are observed.
  • Page 11 4.6 Information on Proximity to Certain Areas CAUTION Insufficient distance to HF communication devices (e.g. mobile phones, Bluetooth devices, WiFi devices) Falling due to unexpected behaviour of the product caused by interference with internal data communication. Therefore, keeping a minimum distance of 30 cm to HF communication devices is recom­ ►...
  • Page 12 4.7 Information on Use CAUTION Walking up stairs Falling due to foot placed incorrectly on stair as a result of changed damping behaviour. Always use the handrail when walking up stairs and place most of the area of the sole of ►...
  • Page 13 CAUTION Improper mode switching Falling due to unexpected behaviour of the product because of changed damping behaviour. ► Ensure that you stand securely during all switching processes. Verify the changed damping characteristics after switching and observe the feedback from ► the acoustic signal emitter.
  • Page 14 CAUTION Safety mode cannot be activated due to malfunction caused by water penetration or mechanical damage Falling due to unexpected behaviour of the product because of changed damping behaviour. Do not continue using the defective product. ► Consult the O&P professional promptly. ►...

  • Page 15: Scope Of Delivery And Accessories

    Ask the O&P professional and/or therapist to instruct you regarding the functionality and ► adjustment options for all parameters of the MyModes. CAUTION Independently applied changes or modifications made to the mobile device Falling due to altered damping behaviour as a result of unexpected switching to a MyMode. Do not make any independent changes to the hardware of the mobile device on which the ►...

  • Page 16: Charging The Battery

    6 Charging the battery The following points must be observed when charging the battery: • Use the 757L16-4 power supply unit and 4E60* battery charger to charge the battery. • With average use, the capacity of the fully charged battery is sufficient for about 5 days. •...
  • Page 17 1) Connect the inductive charger to the receiver of the charging unit on the rear of the product. The charger is held in place by a mag­ net. → The LED ring on the rear of the charger pulsates purple (4-second cycle).

  • Page 18: Cockpit App

    38% – Charge level of battery for currently connected component 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. Quantity Battery charge level 0%-10%...
  • Page 19 7.2 Initial connection between cockpit app and prosthesis The following points should be observed before the initial connection: • Bluetooth of the component must be switched on (see page 29). • Bluetooth on the mobile device must be switched on. • The mobile device must not be in "flight mode"...
  • Page 20 7.3 Control elements for cockpit app Access the navigation menu (see page 20) 2. Product The component name can only be changed with the adjust­ Product change ment software. 1. Basic Mode 2. Golf 3. If connections to more than one component have been saved, you can switch between the saved components by tapping the entry change.
  • Page 21 7.4 Managing components Connections with up to four different components can be stored in the app. However, a compon­ ent can only be connected to one mobile device at a time. INFORMATION Before establishing the connection, observe the points in the section "Initial connection between Cockpit app and component"...
  • Page 22 If there is an existing connection between the component and a different mobile device, the fol­ lowing information appears while the connection is being established with the current mobile device: ► Tap the "OK" button. → The connection to the last connected mobile device is Connect to this component? broken off and established with the current mobile device.
  • Page 23 Deliberate unlocking of the joint ► By deliberately extending or unloading the knee joint, is it unlocked again. INFORMATION Stance function with hip disarticulation amputation level Due to personal abilities and experiences with prostheses, these users may encounter diffi­ culties with activating/deactivating the stance function. If these users want to stand with a flexed and locked knee joint for extended periods of time, the O&P professional can configure a MyMode that can be activated/deactivated using the Cockpit app.
  • Page 24 8.1.5 Sitting INFORMATION While sitting, the knee joint also switches to energy saving mode. This energy saving mode is activated regardless of whether the sitting function is activated or not. If the patient is in a sitting position for more than two seconds (i.e. the thigh is close to horizontal and there is no load on the leg), the knee joint switches the resistance to a minimum in the extension direction.
  • Page 25 Although the knee joint is passive, which means it cannot actively initiate movements, negotiating stairs step-over-step is possible. This function must be practised and executed consciously. 1) Lift the extended prosthesis off the floor. 2) Immediately after lifting the extended leg off the floor, extend the hip briefly and then abruptly flex it.
  • Page 26 8.1.9 Walking down stairs This function must be practised and executed consciously. Only when the sole is properly positioned can the knee joint react correctly and permit controlled flexion. 1) Hold the handrail with one hand. 2) Position the leg with the prosthesis on the step so that the foot projects halfway over the edge of the step.
  • Page 27 8.2.1 Changing the prosthesis setting using the cockpit app 1) Once the component is connected and in the desired mode, tap the  icon in the main menu. → The navigation menu opens. 2) Tap the “Settings” menu option. → A list appears with the parameters for the currently selected mode.
  • Page 28 Parameter Adjustment Setting Meaning software range, app range Sitting function Deactivated 0 - deactivated Activation/deactivation of the sitting Activated 1 - activated function. For switching with the Cock­ pit app, this function has to be activ­ ated in the adjustment software. Fur­ ther information (see page 24).
  • Page 29 Parameter Adjustment Setting Meaning software range, app range Locking angle 0–90 +/- 10 Angle up to which the knee joint can be extended. Information: If this parameter is >0, the knee joint is locked in a flexed position in the extension direction. To unlock it, unload the prosthesis and tilt it back for at least 1.5 seconds.
  • Page 30 2) Follow the on-screen instructions. → If Bluetooth is switched on, the  symbol appears on the screen. 8.4 Querying the prosthesis status 8.4.1 Query status through cockpit app 1) When the component is connected, tap the  symbol in the main menu. 2) In the navigation menu, tap the entry "Status".
  • Page 31 It can be awakened from deep sleep mode with the Cockpit app or by connecting the battery charger. Waking from deep sleep mode using the Cockpit app can take up to 30 seconds. After ending deep sleep mode, the knee joint is in basic mode again. 8.6.1 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.
  • Page 32 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. 9 MyModes The O&P professional can activate and configure up to five MyModes in addition to basic mode using adjustment software.
  • Page 33 1) Tap the symbol of the MyMode (1) you want in the main menu of the app. → A security question for changing the MyMode appears. Product change 2) If you want to change the mode, tap the "OK" button. 1.
  • Page 34 → A beep and vibration signal will sound to confirm that the movement pattern has been recognised. 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 activ­ ated.

  • Page 35: Additional Operating States (Modes)

    → A confirmation signal will sound to indicate that the prosthesis has successfully switched over to basic mode. INFORMATION: If this confirmation signal does not sound, the leg with the prosthesis was not correctly kept still or mute mode (silent mode) is activated. Repeat the pro­ cess for correct switching.

  • Page 36: Storage And Bleeding

    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 11 Storage and bleeding Air may accumulate in the hydraulic unit if the product is stored for longer periods and not in an upright position.
  • Page 37 14.3 CE conformity Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with applicable European requirements for medical devices. The product meets the requirements of the RoHS Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic devices.

  • Page 38: 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...
  • Page 39 Product Mobility grade (MOBIS) 3 and 4 Maximum body weight including additional 150 kg weight Protection rating IP66 / IP68 Maximum water depth: 3 m Maximum time: 1 hour Water resistance Waterproof, corrosion-resistant, resistant to penetration from jets of water Range of Bluetooth connection to mobile Max.
  • Page 40 Prosthesis battery Charge level after 8 hours charging time Fully charged Product behaviour during the charging process The product is non-functional Operating time of the prosthesis with new, fully Approx. 5 days with average use charged battery at room temperature Power supply unit Reference number 757L16-4...
  • Page 41 16 Appendices 16.1 Symbols Used Manufacturer Type BF applied part 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 protection against water Dust-proof, protected against strong jets of water Dustproof, protection against permanent submersion.
  • Page 42 Lot number (PPPP YYYY WW) PPPP – plant YYYY – year of manufacture WW – week of manufacture Article number Medical device Caution, hot surface Protect from moisture 16.2 Operating states/error signals The prosthesis indicates operating states and error messages through beeps and vibration sig­ nals.
  • Page 43 Beep signal Vibration Additional action per­ Event signal formed 2x short 2x short Weight taken off prosthetic Switching to MyMode 1 (mode 2) leg and leg kept still for 1 carried out. second 3x short 3x short Weight taken off prosthetic Switching to MyMode 2 (mode 3) leg and leg kept still for 1 carried out.
  • Page 44 Beep signal Vibration signal Event Required action – Continuous Total failure Attempt to reset this error Electronic control no by connecting/discon­ longer possible. necting the battery char­ Safety mode active or ger. undetermined valve If the error persists, use state. Undetermined of the product is prohib­...
  • Page 45 Status Charging status Error Resolution indicator (5 LEDs) The LED LED 2 and 4 are lit up Charger excess tem­ Check whether the ring is lit perature specified ambient con­ up yellow ditions for charging the LED 1, 3 and 5 are lit Excessively high or battery are met (see low temperature of the...
  • Page 46 Error message Cause Correction A current connection to Check the following points: the component was • Distance from the component to the interrupted device • Charge level of the component's bat­ tery • Bluetooth of the component switched on? (Switching Bluetooth of the com­ ponent on/off) •...
  • Page 47 Beep Vibration Event Resolution signal signal 3x short 3x short Maintenance note: • Use the Cockpit app to check E.g.: Maintenance interval has been the next maintenance date for exceeded, temporary disruption of a the prosthesis (see page 30). If sensor signal the date is within the next month, make a maintenance appointment with the O&P pro­...
  • Page 48 Electromagnetic emissions Interference meas­ Compliance Electromagnetic environment directive urements HF emissions accord­ Group 1/class B The product uses HF energy exclusively for its ing to CISPR 11 internal functioning. Its HF emissions are therefore very low, and interference with neigh­ bouring electronic devices is unlikely. Harmonics according Not applicable –...
  • Page 49 Interference resistance against wireless communication devices Test fre­ Frequency Radio ser­ Modulation Maximum Distance Interfer­ quency band vice power [W] ence [MHz] [MHz] immunity test level [V/m] 380 to 390 TETRA 400 Pulse modu­ lation 18 Hz 430 to 470 GMRS 460, FRS 460 ± 5 kHz deviation 1 kHz sine...
  • Page 52 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...

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Genium x3 3b5-3