Otto Bock Genium X3 Instructions For Use Manual
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Otto Bock Genium X3 Instructions For Use Manual

Bionic prosthetic system
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Genium X3 - Bionic Prosthetic System
Instructions for Use (Qualified Personnel) 3

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Summary of Contents for Otto Bock Genium X3

  • Page 1 Genium X3 - Bionic Prosthetic System Instructions for Use (Qualified Personnel) 3...
  • Page 3 4R104=60 4R57 4R41 4R111=N 4R119 4R40 4R118 4R104=75 4R57=ST 4R43 4R111 4E60 757L16-* 4R89 4R116 with Pyramid Adapter with Screw Top 4H102 4H101 not illustrated 4X194 4X350-X3 Wristband 3B5-X3 3B5-X3=ST 4X193 2R19 1M10 1C30/1C31 1C40 1D35 4X1=* X-Soft 1E56 1E57 1C60 60X5 BionicLink PC 1C61...

  • Page 4: Table Of Contents

    INFORMATION Last update: 16 October 2013 • Please read this document carefully • Follow the safety instructions and the stated precautions in this accompanying document • If assistance is required during the start-up, use or maintenance of the product, as well as in the event of unexpected operating behaviour or circumstances, contact the manufacturer (see manufacturer‘s address on the back of this accompanying document) Table of Contents 1 Intended Use .............................6 11 Medical Purpose  6 12 Field of Application  6 13 Conditions of Use  7 14 Qualifications  7 141 Qualifications of the Prosthetist  7 142 Qualifications of the Therapist and Nursing Staff   7 15 Functions  7 16 Safety Instructions  7 17 Scope of Delivery  7 18 Recommended Accessories   7...
  • Page 5 69 Mute mode 24 610 Remote control Adjustments  24 611 Managing Prosthesis  25 612 Connecting to the Prosthesis during Normal Operation 25 613 Charging the remote control  26 614 Completing the Fitting 26 7 Important Information for Patients ....................27 71 Safety Messages and Safety Modes  27 72 Charging Status 29 73 Storage and Ventilation  29 74 Cleaning and Care 29 75 Service  29 76 Warranty  30 77 Technical Information 30 771 General Information 30...

  • Page 6: Intended Use

    Intended Use Explanation of symbols in the instructions for use Warnings regarding directly impending risks of severe accident or injury DANGER Warnings regarding possible risks of severe accident or injury WARNING Warnings regarding possible risks of accident or injury CAUTION Warnings regarding possible technical damage NOTICE 1 Intended Use INFORMATION Read these instructions carefully before using the knee joint! Pay particular attention to the safety instructions! The patient must be taught how to handle, care for and operate his/her prosthesis properly See the following sections: 13 Conditions of Use, 15 Functions, 16 Safety Instructions, 21 Charging the knee joint, 5 MyMode Motion Switching, 6 remote control, 7 Important Information for Patients, 9 Liability Only start up the product in accordance with the information contained in the accompanying documents supplied Instruct the patient in the proper use and care of the product The product may not be transferred to the patient without prior instruction 1.1 Medical Purpose The knee joint is to be used exclusively for exoprosthetic fittings of the lower extremity 1.2 Field of Application The Genium X3 was designed for broad field of application and can be used by transfemoral amputees as well as by active hip disarticulation amputees For knee disarticulation amputees, a version for long residual limbs is available (3B5-X3=ST) The patient must fulfill the following requirements: • The patient must fulfill the physical and mental requirements for the perception of audible signals and/or me- chanical vibrations • The skin on the residual limb must be completely healed...

  • Page 7: 13 Conditions Of Use

    Intended Use 1.3 Conditions of Use INFORMATION Advise your patients of the information in this section The knee joint was developed for everyday activities Misuse and abuse is not covered under warranty See Sec- tion 77 “Technical Information“ for the permitted ambient conditions The Genium X3 System is designed exclu- sively for use on one patient Use of the product by other persons is not approved by the manufacturer 1.4 Qualifications 1.4.1 Qualifications of the Prosthetist Only prosthetists who have been authorised by Ottobock after completing a corresponding training course may fit patients with the knee joint 1.4.2 Qualifications of the Therapist and Nursing Staff The therapists or nursing staff must be trained in handling the knee joint (and accessories) by the authorised prosthetist 1.5 Functions The knee joint is a electronic knee joint system with hydraulic stance and swing phase control Microprocessor-...

  • Page 8: 19 General Safety Instructions

    Intended Use 1.9 General Safety Instructions CAUTION Alignment and adjustment errors. When fitting and adjusting the prosthesis, errors can occur, which can cause malfunctions of the knee joint including loss of function due to structural failure This may cause the pa- tient to fall • Participation in an Ottobock product training course for the knee joint is mandatory prior to the first fitting Additional product training courses may become necessary to qualify for product updates • Correctly entering the foot size, the prosthesis dimensions and the body weight are important criteria for the quality of the fitting If the values are too high, the prosthesis may not trigger the swing phase If the values are too low, the prosthesis may trigger the swing phase at the incorrect time CAUTION Use of unsuitable prosthetic components. If unsuitable prosthetic components are installed in the prosthe- sis, malfunction of the joint and a loss of functionality due to structural failure may occur This may cause the patient to fall Only combine the knee joint with adapters and feet tested by Ottobock (see system overview, front) Ensure that the waterproofness and corrosion resistance of every single prosthetic component is considered individually Ottobock assumes no liability if the knee joint is used with components other than those specified (see system overview, front) CAUTION Manipulation of system components. Independent changes and / or modifications of system components may lead to malfunction of the knee joint and a loss of functionality due to structural failure This may cause the patient to fall • Any changes or modifications to the knee joint may limit its use • The knee joint may only be opened and repaired by authorised Ottobock technicians and the battery may only be handled by Ottobock Service Centres (no independent battery replacement) CAUTION...

  • Page 9: 10 Patient Information

    Intended Use CAUTION Transport damage. Mechanical impacts or stress during transportation of the knee joint such as shocks and vibrations can lead to: • Defects and resulting knee joint malfunctions • Battery and hydraulic unit defects, resulting in leaks • Loss of functionality due to structural failure This may cause the patient to fall and can result in skin irritation Use the original packaging when transporting the knee joint CAUTION Consequences of product deterioration. Wear and tear on system components can lead to malfunctions of the knee joint This may cause the patient to fall In the interest of patient safety and in order to maintain reliability and protect the warranty, the specified service intervals must be observed 1.10 Patient Information CAUTION Magnetic interference. The knee joint can malfunction when near high-voltage power lines, transmitters, transformers, CT scanners or other sources of strong electromagnetic radiation (such as security systems for goods in deapartment stores or body scanners in airport areas) This may cause the patient to fall Avoid proximity to strong sources of magnetic and electric interference (eg transformer stations, transmitters) If this can not be avoided, make sure to go or to stand securely (eg by means of handrail or the support of a person)...
  • Page 10 Intended Use CAUTION Penetration of dirt and humidity. Penetration of dirt and humidity into the system components can lead to: • Short circuits in the electronics and battery, resulting in malfunctions of the knee joint • Hydraulic unit defects with an associated leakage of fluid or a loss of functionality due to structural failure This may cause the patient to fall and/or result in skin irritation • Ensure that no particles can penetrate the system components • The knee joint and the AXON tube adapter are waterproof They must not be used under extreme conditions like diving or jumping into the water and are not intended to be used under water permanently • After using the knee joint in a salt water environment, remove the protector, rinse knee joint and protector with fresh water and let them dry • Should the knee joint come into contact with solutions other than fresh or salt water, it must be rinsed with fresh water immediately (also see Section 74, Cleaning and Care) • The knee joint is not resistant against penetration with water jets or steam • If there is a water leakage into the electronic system, the knee joint must be sent to an authorised Ottobock Service Centre for inspection Please contact your prosthetist CAUTION Improper use of the joint. Any kind of overloading or excessive strain as well as improper use can lead to: • Defects and resulting knee joint malfunctions • Loss of functionality due to structural failure • Battery and hydraulic unit defects resulting in leaks This may cause the patient to fall and can result in skin irritation The knee joint was developed for everyday use Misuse and abuse is not covered under warranty Careful handling of the prosthesis and its components not only increases their service life but, above all, ensu-...
  • Page 11 Intended Use CAUTION Improper MyMode switching. In case of improper MyMode switching into basic mode or vice versa, there is a risk of falling (see Section 65 MyMode Switching via remote control)! • After switching to a MyMode, verify the function since you may have activated a MyMode other than the intended one (see Section 5 “MyMode Motion Switching“ and Section 65 “MyMode Switching via remote control“) • Ensure that you return to basic mode when you have completed your activities in the MyMode CAUTION MyMode switching via remote control. The patient can use the remote control to initiate different actions changing the damping behaviour of the knee joint In certain situations, this may cause the patient to fall I f you inadvertently selected the wrong action with the remote control (vibration or audible signal), take the load off the knee joint and correct the command CAUTION Consequences of product deterioration. Wear and tear on system components can lead to malfunctions of the knee joint This may cause the patient to fall...

  • Page 12: 11 Installation Of X-Soft 12

    Alignment and Adjustment of the Prosthesis CAUTION Distance to HF communication devices is too small (e.g. mobile phones, Bluetooth devices, WiFi de- vices). Unexpected prosthesis behaviour due to interference with internal data communication In certain situ- ations, this can cause the user to fall Therefore, maintain the following minimum distance from these HF communication devices: • Mobile phone GSM 850/GSM 900: 099 m • Mobile phone GSM 1800/GSM 1900/UMTS: 07 m • DECT cordless phones incl base station: 035 m • WiFi (routers, access points,…): 022 m • Bluetooth devices (third-party products not approved by Ottobock): 022 m 1.11 Installation of X-Soft To install and register X-Soft, please refer to the X-Soft Instructions for use 647G819 2 Alignment and Adjustment of the Prosthesis 2.1 Charging the knee joint INFORMATION Advise your patients of the information in this section...
  • Page 13 Alignment and Adjustment of the Prosthesis INFORMATION Hold the joint still while it is performing the self-test, ie immediately after removing the charger Otherwise, error messages may occur They can be rectified by connecting and removing the charger INFORMATION Charging is no longer possible when the distance between the transmitter and receiver is greater than 2 mm However, charging should not be a problem if there is a sock or Superskin between transmitter and receiver of the charger (See also the charging process table) Charging process: LEDs Charging 0%-10% 10%-30% 30%-50% 50%-70% 70%-90% >90% status Charging process table: Status Status LED Charging status indicator AC Adapter is connected, but the Continuous green All five LEDs off charger is not connected to the knee joint Charger connected to knee joint Charging status indicator (green)

  • Page 14: 22 Connecting The Axon Tube Adapter 14

    Alignment and Adjustment of the Prosthesis CAUTION Feedback is disabled in mute mode. When the mute mode is active, all vibration and beep signals are di- sabled and the knee joint will go into low battery mode without any warning! If unexpected, this can cause the patient to fall Be aware of this fact before activating the mute mode 2.2 Connecting the AXON Tube Adapter 1 Determine the required length of 2R19 AXON Tube Adapter with the configuration software X-Soft 2 Shorten the AXON Tube Adapter to the determined value with the 719R3 AXON Tube Adapter cutter (Fig 1) Smooth the cutting surface with a 718S2 countersink and sandpaper (Fig 2) If necessary, smooth by machine the material raised at the outer edge when shortening the AXON Tube Adapter, and always countersink the interior to prevent damage to the AXON Tube Adapter cable 3 Finally, the plug cover must be removed INFORMATION Do not cut the AXON Tube Adapter below the 365 mm value on the tube adapter scale CAUTION Risk of cable damage. If the cable is damaged when cutting the AXON Tube Adapter to length, malfunctions of the knee joint may follow This may cause the patient to fall Ensure the cable is not damaged INFORMATION If the AXON Tube Adapter is disconnected when the knee joint is activated and the charger is not attached, a safety mode is activated and the knee joint sends a warning signal If the AXON Tube Adapter is connected again and then the knee joint is reset by connecting and removing the charger, it returns to normal mode INFORMATION If the knee head is fully flexed while the joint is standing upright, the joint switches to sitting or energy-saving mode after 2 seconds Then the tube adapter can be disconnected without triggering an error message Ensure that there is no active Bluetooth connection...
  • Page 15 Alignment and Adjustment of the Prosthesis 6 Push the protruding cable loop into the AXON Tube Adapter (Fig 5) When the AXON Tube Adapter has been shortened to the minimum length, the plug must be inserted in the cavity (Fig 6) The cable loop must then be stored carefully 7 Push the AXON Tube Adapter 60 mm into the knee joint (Fig 7) Corrections to min 40 mm and max 70 mm insertion depth of the AXON Tube Adapter into the knee joint are permitted CAUTION Inserting the AXON Tube Adapter. If the AXON Tube Adapter is not inserted far enough into the knee joint, a loss of functionality due to structural failure can result This may cause the patient to fall For reliable operation, the AXON Tube Adapter must be inserted at least 40 mm INFORMATION If the length must be adjusted by pushing the AXON Tube Adapter in or out during subsequent trials, the patient must always be seated Before the body weight is supported on the prosthesis after adjusting the length, the screws on the tube clamp of the knee joint must first be tightened to the prescribed torque values 8 Turn the foot outwards slightly, and tighten both screws on the terminal clamp slightly using an Allen key (size 4 mm) (approx 4Nm) (Fig 8) INFORMATION • the AXON Tube Adapter is shortened excessively, • the foot has been replaced with a foot with insufficient system height, • a shorter AXON Tube Adapter is used in the event of a service joint, intermediate adapters (eg 4R84) are used to compensate for the height difference If this is the case, the knee axis-ankle adapter distance must be re-entered in the software In general, the AXON Tube Adapter should be left as long as possible Genium X3 - Bionic Prosthetic System Ottobock | 15...

  • Page 16: Torque Values Of The Screw Connections

    Torque values of the screw connections 3 Torque values of the screw connections CAUTION Failure to comply with torque values. Failure to comply with the torque values of the screw connections can lead to a loss of functionality due to structural failure This may cause the patient to fall Compliance with the specified torque values is essential in order to ensure operational reliability 15 Nm 15 Nm 7 Nm Use a 710D4 Torque Wrench with a 710Y2=4 Hex Bit to tighten the screws alternately, in several steps increasing the torque slowly, until the prescribed torque is reached: 1 Tube adapter: 15 Nm 2 Clamp: 7 Nm 3 Fitting for short residual limb 4 W hen using a rotation adapter or sliding adapter: 15 Nm 3.1 Configuring Control of the Prosthesis via X-Soft To configure the prosthesis, please refer to the X-Soft Instructions for use 647G819 In addition to all functions described in the X-Soft instructions, the knee joint offers a running function 3.1.1 Running function in Basic Mode...

  • Page 17: 4H101/4H102 Flexion Stops

    4H101/4H102 Flexion stops 4 4H101/4H102 Flexion stops CAUTION Errors in prosthesis alignment. Errors made during the alignment of the prosthesis can damage the hydraulic unit of the joint A defective hydraulic unit can lead to joint malfunction up to loss of function due to structural failure This can cause the patient to fall The hydraulic unit may be destroyed if it comes into contact with the socket! At maximum flexion, it is essential to maintain a minimum distance of 3 mm (1/8“) between the hydraulic unit and the socket At maximum flexion, the knee joint must be equipped with a flexion stop if contact with the frame of the knee joint cannot be avoided (voluminous residual limbs) 4H101 4H102 15° 7,5° When delivered, the knee joint is equipped with the 4H102 Flexion Stop, which reduces the maximum flexion angle by 15°, thus preventing contact with the hydraulic unit It is also possible to equip the knee joint with the smaller 4H101 Flexion Stop, which reduces the flexion angle by 75° INFORMATION If no flexion stop is desired, the knee joint can also be used without a flexion stop (the screws are removed to- gether with the flexion stop) In this case, it must be ensured that the socket and the hydraulic unit do not collide To switch to the smaller 4H101 Flexion Stop: 1 Loosen the screws with the 710H5=1 Screwdriver (Fig 1) 2 Remove the 4H102 Flexion Stop and insert the 4H101 Flexion Stop (Fig 2) 3 Clean the screw thread with a brush Apply Loctite 243 onto the screw thread and tighten the screws (Phillips Recess size 1) with a dynamometric key with 60 NM Genium X3 - Bionic Prosthetic System Ottobock | 17...

  • Page 18: Mymode Motion Switching

    MyMode Motion Switching 5 MyMode Motion Switching INFORMATION Advise your patients of the information in this section 5.1 Switching to MyModes without a remote control If switching by bouncing up and down has been activated in X-Soft, you can switch without a remote control by bouncing up and down on the forefoot three times in a second, with the foot remaining in contact with the ground at all times and the prosthetic leg extended While doing so, the forefoot has to bear approximately 40% of the total body weight at peak load and less than approximately 25% of the body weight at the lowest load However, the load may not be taken off the foot fully 3 × in 1 second 1 second After the audible signal sounds (one long beep and a long vibration signal), your weight must be taken off the prosthesis entirely for at least one second with the knee extended (no ground contact) Then the knee joint swit- ches to the first MyMode and emits two short Beep and vibration signals The procedure for switching to the second MyMode is the same, except for bouncing up and down four times In this case, the switch is indicated by three short Beep and vibration signals Bouncing at least three times to return to basic mode from any MyMode The switch is confirmed by a short Beep and vibration signal If only triple bouncing is activated but quadruple bouncing is not, you can access the first MyMode via any number of bouncing motions greater or equal to 3 INFORMATION Switching back to basic mode by bouncing up and down three or more times cannot be deactivated Thus, you can access basic mode even if switching via bouncing is not enabled in X-Soft INFORMATION Returning to basic mode is also possible by connecting the battery charger CAUTION Feedback is disabled in mute mode. When the mute mode is active, no feedback will be given when swit- ching into a MyMode or back to basic mode If switching was unsuccessful, the behaviour of the knee joint may be unexpected This may result in a risk of falling Make sure that the switching process has been successful before continuing...

  • Page 19: Remote Control

    Remote control 6 Remote control 6.1 Introduction INFORMATION Advise your patients of the information in this section The knee joint can be used in normal operation in basic mode (incl optional Intuitive Stance function, Sitting function, Stairs and Obstacles function and OPG function) and in up to five different MyModes The MyModes can be activated using the remote control Basic mode is used on a day-to-day basis, while the MyModes are pre-programmed for specific movements and / or postures such as standing at a workbench, cycling, inline skating or cross-country skiing X-Soft is used to configure which MyModes are used as well as their settings However, some parameters can also be adjusted with the remote control CAUTION Improper MyMode switching using the remote control. MyMode switching using the remote control chan- ges the damping behaviour of the knee joint In certain situations, this may cause the patient to fall The patient must stand securely when switching between modes and must carefully confirm whether the desi- red function was successfully set by the knee joint CAUTION Penetration of water into the remote control. The remote control is not waterproof Under ambient condi- tions where the remote control may get wet, using the supplied 4X194 Arm Band for protection is recommen- ded If water penetrates the remote control, the device may be damaged This can lead to malfunctions of the remote control, result in unexpected actions of the knee joint and cause the patient to fall Should the remote control accidentally come into contact with water then be dried at room temperature for at least 1 day Before using the remote control again, send it to an authorised Ottobock Service Centre CAUTION Manipulation on the remote control. Any unauthorised changes or modifications you make to the remote control can lead to malfunctions and result in unexpected actions of the knee joint This may cause the patient to fall Any changes or modifications to the device may limit its usability...

  • Page 20: 64 Status Bar 20

    Remote control 6.2 Control Elements of the remote control INFORMATION Advise your patients of the information in this section 1 LCD screen 2 Enter button 3 Navigation buttons: left, right, up, down 4 Charging receptacle 6.3 Initial Connection between the remote control and the knee joint (Pairing) 1 Press the enter button to activate the remote control The start-up screen with the date, time and charging state of the remote control is displayed Without additional input, the remote control turns off automatically after 5 seconds 2 Press to attempt to connect the device The remote control searches for active prostheses 3 When a knee joint is found (serial number is shown), press enter to confirm If several knee joints are found, the serial number of the desired knee joint has to be selected using the navigation keys (display: serial num- ber) The configuration data from the knee joint is then loaded...

  • Page 21: 65 Mymode Switching Via Remote Control 21

    Remote control 6.5 MyMode Switching via remote control INFORMATION Advise your patients of the information in this section Once an active connection to the prosthesis has been established, the remote control can be used to switch between MyModes 1 Select "Mode" in the main menu and press the enter button to confirm 2 A list of the available MyModes is displayed Press to select the required MyMode and the enter button to confirm If you open the MyMode list by accident, you can select the active MyMode again • Feedback from the prosthesis: 1 long vibration signal and 1 long beep signal 3 You can switch off the remote control by selecting and confirming "RC Power off" 6.6 Changing Prosthesis Settings INFORMATION Advise your patients of the information in this section...

  • Page 22: 67 Deep Sleep Mode  22

    Remote control If the settings of another MyMode are to be modified, you must first switch to this MyMode (see Section 65 "My- Mode Switching via remote control") INFORMATION The prosthetist‘s setting is usually found in the middle of the scale After adjustment, you can reset the prosthetist‘s setting by moving the slider control into the middle INFORMATION The knee joint settings should be optimised by the prosthetist using X-Soft The remote control is not intended for use by the prosthetist to configure the knee joint The patient can change the behaviour of the prosthesis to a certain extent on a day-to-day basis using the remote control (eg while becoming accustomed to the pros- thesis) The prosthetist can monitor the changes using X-Soft at the next appointment The table below shows the adjustment parameters for the MyModes along with a brief description, the adjustment range of the remote control around the value selected by the prosthetist and the absolute value range Basic mode: Slider name in X-Soft Absolute range Remote control Description adjustment range Stance flexion resis-...

  • Page 23: 68 Querying The Prosthesis Status 23

    Remote control Proceed as follows to activate deep sleep mode: 1 Select “Device Settings“ in the main menu and confirm the selection 2 A list of the parameters available for the current MyMode is displayed The entry “Deep sleep“ is at the end of this list; select it and press the enter button 3 A confirmation prompt is displayed Press the enter button again • Feedback from the prosthesis: 1 short beep signal and 1 short vibration signal Proceed as follows to wake the knee joint using the remote control: 1 Activate the remote control by pressing the enter button and  2 Select the "Device Power On" menu entry and press the enter button to confirm 3 The knee joint is reactivated after 20 seconds at the latest with a single beep and vibration signal The knee joint is then in basic mode again Alternatively, the knee joint can be woken by attaching the charger INFORMATION Deep sleep mode is not available if the joint is in safety mode 6.8 Querying the Prosthesis Status...

  • Page 24: 69 Mute Mode 24

    Remote control 6.9 Mute mode INFORMATION Advise your patients of the information in this section The remote control can be used to send the knee joint into a mute mode, in which all vibration and beep signals are disabled All other functions of the knee joint are unaffected The mute mode can be disabled with the remote control or by attaching the charger Proceed as follows to activate the mute mode: 1 Select „Status“ in the main menu and press enter to confirm 2 Navigate to the entry „Mute“ and press enter to confirm To deactivate the mute mode repeat this procedure, or connect the Charger CAUTION Feedback is disabled. When the mute mode is active, all vibration and beep signals are disabled In case of a mode change, low battery or system errors, the mode will be changed (or safety modes will be activated, respectively) without warnings If unexpected, this can cause the patient to fall Be aware of this fact before activating the mute mode 6.10 Remote control Adjustments INFORMATION Advise your patients of the information in this section 1 In the main menu, select "RC Settings" and press enter to confirm 2 Select the corresponding line to change the date and time Use the navigation buttons to change the settings 3 You can then set up other connections ("Pairing") Connections can be deleted ("Delete Connection") (see Section 611 "Managing Prosthesis") 4 The font size in the menu bar can be changed by selecting "Zoom"...

  • Page 25: 11 Managing Prosthesis  25

    Remote control 7 Information about the firmware version of the knee joint and signal strength is accessible under “Info“ Select the arrow symbol to return to the main menu on the display 6.11 Managing Prosthesis Connections with up to four different prostheses can be stored in a single remote control Conversely, a prosthe- sis can only be connected to a single remote control Complete the following steps to add additional connections: 1 In the main menu, use to select "RC Settings" and press enter to confirm 2 Select "Pairing" from the menu that appears 3 The remote searches for other prostheses in range (display: "Device scan") 4 Press the enter button to confirm if another prosthesis is found If several additional prostheses are found, the serial number of the desired prosthesis has to be selected using the navigation keys (display: serial number) Press to select one of the four items and press the enter button to confirm One of the existing connections can also be overwritten The configuration files are loaded from the prosthesis and the main menu is displayed To delete an existing connection, please follow the steps below: 1 In the main menu, use to select "RC Settings" and press enter to confirm 2 In the menu which is then displayed, select "Delete Connection" and press enter to confirm 3 Use to select the connection to be deleted and press enter to confirm 6.12 Connecting to the Prosthesis during Normal Operation INFORMATION...

  • Page 26: 13 Charging The Remote Control  26

    Remote control 1 To change the active connection, select the name of the current connection in the main menu and press enter to confirm 2 In the list of saved connections which is then displayed, select the required connection and press enter to confirm 3 If the chosen connection cannot be re-established, a reduced main menu appears Choose “Select device“ to activate another selected connection In some cases following service, the connection cannot be restored even though the joint is within range of the remote control In this case, the existing connection must be erased and the pairing process has to be completed again 6.13 Charging the remote control INFORMATION Advise your patients of the information in this section Disconnect the charging cable from the charger for the knee joint and connect it to the charging receptacle of the remote control Depending on how often the remote control is used, it should last two months on a single charge The battery charge level of the remote control is shown at the top left of the display (see Fig1, Section 63 “Initial Connection between the remote control and the knee joint (Pairing)“) Fully charging the remote control battery takes a maximum of 3-4 hours 6.14 Completing the Fitting CAUTION Securing the screws. If the screws are not secured properly, loss of functionality due to structural failure may result This may cause the patient to fall • The screws must be secured in order to ensure operating reliability • Upon finalising all settings, all screws must be fastened and tightened to the proper torque (see Section 3 "Torque values of the screw connections") • The screws must then be secured with 636K13 Loctite 26 | Ottobock Genium X3 - Bionic Prosthetic System...

  • Page 27: Important Information For Patients

    Important Information for Patients 7 Important Information for Patients INFORMATION Advise your patients of the information in this section 7.1 Safety Messages and Safety Modes Symbols used: Charging status 25% short beep signal Charging status 10% long beep signal Vibration signal Total failu- re or continuous charging short vibration signal status 0% long vibration signal Hydraulic system every overheated 5 seconds Colours used: no action requi- Information Charger attached to...
  • Page 28 Important Information for Patients Type of error Event User restriction Required action eg service interval has No restriction Consult Ottobock Minor error expired eg a sensor (tube adap- Restart the knee joint by ter, triple sensor, ) is not attaching and removing operating inductive charger (up to Medium error three times); Selftest failure (if signals If error remains, consult occur after removing the Ottobock immediately charger) Walking possible with AXON Tube Adapter has restrictions (activation of been disconnected while safety mode) the knee joint is activated and the inductive charger AXON Tube Adapter Connect the AXON Tube is not attached disconnected Adapter...

  • Page 29: 72 Charging Status 29

    Important Information for Patients CAUTION Feedback is disabled. When the mute mode is active, all vibration and beep signals are disabled In case of a low battery or system errors, the safety modes will be activated without warnings If unexpected, this can cause the patient to fall Be aware of this fact before activating the mute mode CAUTION Non-active safety mode. If the safety mode can no longer be activated, there is the risk that the patient will fall If the knee joint can no longer be set to safety mode, the patient must actively secure the knee joint with the residual limb musculature upon heel strike and visit a prosthetist as soon as possible CAUTION Danger when activating safety mode. The damping characteristics of the knee joint change when a safety mode is activated In certain situations, this may cause the patient to fall When the audible and vibration signals are emitted simultaneously, the patient must immediately stop all activi- ties involving the leg prosthesis After approximately 10 seconds, and from a secure standing position, check to see if stance phase resistance is active by slightly bending the knee joint repeatedly under controlled weight bearing CAUTION Safety mode cannot be deactivated. If the knee joint is in safety mode, it is probably defective When in this condition, malfunctions can occur This may cause the patient to fall If the safety mode cannot be deactivated by recharging the battery, an error has occurred Contact the prosthe- tist to have the error corrected 7.2 Charging Status During normal operation, the battery charge level is indicated via vibration signals (in addition to the display on the remote control) (see Section 21 “Charging the knee joint“) 7.3 Storage and Ventilation When storing the knee joint, push the knee head to the flexion stop When using the knee joint again, hold the knee joint with the the knee head facing upwards and push the top of the knee until it is fully extended If the knee joint is stored in a position other than vertical for an extended period, air can gather in the hydraulic...

  • Page 30: 77 Technical Information 30

    Important Information for Patients 7.6 Warranty Ottobock offers a comprehensive warranty on the basis of the current 3B5-X3/3B5-X3=ST service and warranty concept For details, please consult the 3B5-X3/3B5-X3=ST Service Pass (646D589=*) included in the scope of delivery In the interests of the medical supply company providing the fitting, the instruction of the patient and the transfer of the leg prosthesis system must be confirmed by the patient in writing 7.7 Technical Information 7.7.1 General Information Ambient conditions Operating, storage and transport temperature with packaging: -10 °C to +60 °C (14 °F to 140 °F) Operating, storage and transport temperature without packaging: -10 °C to +60 °C (14 °F to 140 °F) Battery charging temperature: 0 °C to +45 °C (32 °F to 113 °F) Relative humidity range: up to 93 % Operating voltage of the battery charger: 100 V to 240 V AC Operating frequency of the battery charger: 50 Hz to 60 Hz Remote control charging cycles (battery) (charging and discharging cycles) after which at least 80% of the original battery capacity remains available: Charging cycles, Li-Ion battery (joint) (charging and discharging cycles) after which at least 80% of the original battery capacity remains availab- 7.7.2 Knee joints Description 3B5-X3 3B5-X3=ST Proximal connection Pyramid adapter Threaded adapter Distal connection Tube clamp...

  • Page 31: 78 Symbols On The Knee Joint 31

    Important Information for Patients 7.7.3 AXON Tube Adapter Description 2R19 Weight 190-300 g / 042-066 lbs Material Aluminium Body weight max 125 kg (275 lbs) Waterproofness of the AXON tube adap- IPX7, protected against water immersion but not against jets of water or steam 7.8 Symbols on the knee joint Declaration of conformity according to the European Directive for Medical Devices 93/42/EEC and 1999/5/ EU Caution, hot surface Serial number of the device Compliance with the requirements according to „FCC Part 15“ (USA) Legal manufacturer Non-ionising radiation This product may not be disposed of with regular domestic waste Disposal that is not in ac- cordance with the regulations of your country may have a detrimental impact on health and the en- vironment Please observe the information provided by the responsible authorities in your country regarding return and collection processes 7.9 Symbols on the remote control Declaration of conformity according to the European Directive for Medical Devices 93/42/EEC and 1999/5/ EC with the number of the specified authority (0681) 0681 Lot number...

  • Page 32: 10 Symbols On The Inductive Charger 32

    Definition of Terms 7.10 Symbols on the Inductive Charger Declaration of conformity according to the European Directive for Medical Devices 93/42/EEC Lot number Legal manufacturer This product may not be disposed of with regular domestic waste Disposal that is not in ac- cordance with the regulations of your country may have a detrimental impact on health and the en- vironment Please observe the information provided by the responsible authorities in your country regarding return and collection processes 8 Definition of Terms Ground reaction force: Lowering the foot to the ground, and thus applying body weight, results in a ground reaction force The software model indicates the vector of the total effective ground reaction force and the vector of the horizontal component of the ground reaction force Terms relating to body planes and position: Anterior: At the front Posterior: At the rear Lateral: At the side Proximal: Towards the body Distal: Away from the centre of the body Flexion: Bending Extension: Stretching Plantar flexion: Lowering the bottom of the foot towards the ground Dorsiflexion: Lifting the top of the foot...
  • Page 33 Definition of Terms 1 Plantar flexion 2 Dorsiflexion 3 Posterior socket shifting 4 Anterior socket shifting 5 Knee flexion 6 Knee extension Thomas test: The Thomas test is a method to determine the range of motion of the hip and, in particular, a hip flexion contrac- ture 1 To determine the extent of hip flexor contracture, the patient lies on an examination table or other level surface without their prosthesis 2 Place one hand under the lordosis of the patient’s lumbar spine Now the patient uses both arms to pull the sound leg as close as possible to the body until the spine is pressing on your hand This fixates the pelvis in the normal position 3 Determine the hip flexion contracture on the affected side The hip flexion contracture corresponds to the angle between the thigh and the horizontal plane If the patient is able to fully extend the hip of the affected side, there is no hip flexion contracture Enter the value of flexion contracture in X-Soft under "Residual limb / Hip flexor contracture" Determining a socket reference point: 1 Mark the centre of the distal part of the socket in the sagittal plane 2 Mark the proximal centre in the sagittal plane 3 Connect the two points with a line and extend it to the lowest point of the socket...

  • Page 34: Liability

    Liability INFORMATION Since the trochanter is often difficult to recognise as a reference point or because of changes in the hip and pelvic region due to the amputation, this process to determine the socket reference point as the assumed hip rotation point is intended to facilitate prosthesis alignment INFORMATION If the LASAR/PROSA Assembly is used, the socket reference point must be marked when the prosthesis is already secured in the alignment unit This is due to the 5° outward rotation of the prosthesis in the alignment unit 9 Liability The product may only be used under the specified conditions and for the intended purpose, and in conjunction with the modular component combinations tested for the prosthesis, in accordance with the Ottobock MOBIS mobility system, and in accordance with the instructions for use The manufacturer is not liable for damage caused by component combinations that were not authorised by the manufacturer 10 Trademarks All product names mentioned in this accompanying document are subject without restriction to the respective applicable trademark 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 Should trademarks used in this accompanying document fail to be explicitly identified as such, this does not justify the conclusion that the respective designation is free of third-party rights 11 CE Conformity The knee joint meets the requirements of the 93/42/EEC guidelines for medical devices This device has been classified as a class I device according to the classification criteria outlined in appendix IX of the guidelines The declaration of conformity was therefore created by Ottobock with sole responsibility according to Appendix VII of...
  • Page 36 FCC-Statement: This device complies with part 15 of the FCC Rules Operation is subject to the following two conditions: 1) This device may not cause harmful interference, and 2) this device must accept any interference received, including interference that may cause undesired operation This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules These limits are designed to provide reasonable protection against harmful interference in a residential installation This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications However, there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: —Reorient or relocate the receiving antenna —Increase the separation between the equipment and receiver —Connect the equipment into an outlet on a circuit different from that to which the receiver is connected —Consult the dealer or an experienced radio/ TV technician for help Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment 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 Two Carlson Parkway North, Suite 100 55447 Minneapolis, Minnesota, USA Phone + 1-763-553-9464 This device complies with RSS 210 of Industry Canada Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of this device L ‘ utilisation de ce dispositif est autorisée seulement aux conditions suivantes: (1) il ne doit pas produire d’interference et (2) l’ utilisateur du dispositif doit étre prêt à accepter toute interference radioélectrique reçu, même si celle-ci est susceptible de compromettre le foncti- onnement du dispositif Caution: Exposure to Radio Frequency Radiation The installer of this radio equipment must ensure that the antenna is located or pointed such that it does not emit RF field in excess of Health Canada limits for the general population; consult Safety Code 6, obtainable from Health Canada’s website http://wwwhc-scgcca/rpb Responsible party: Otto Bock Healthcare Canada Ltd 5470 Harvester Road L7L 5N5 Burlington, Ontario Canada Otto Bock Healthcare Products GmbH Kaiserstraße 39 · 1070 Wien · Austria T +43-1 523 37 86 · F +43-1 523 22 64 infoaustria@ottobockcom · wwwottobockcom Ottobock has a certified Quality Management System in accordance with ISO 13485...

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