Related Manuals for Otto Bock Genium X3 Series
Summary of Contents for Otto Bock Genium X3 Series
- Page 1 Genium X3 - Bionic Prosthetic System 3B5-X3/3B5-X3=ST Patient information � �������������������������������������������������������������������������������������������������������������� 3...
-
Page 3: Explanation Of Symbols
INFORMATION Last update: 16 October 2013 • Please read this document carefully� • Follow the safety instructions and the precautions specified in this accompanying document� • Please contact the responsible prosthetist if assistance is required during the start-up, use or maintenance of the product, or in the event of unexpected operating behaviour or circumstances� Explanation of symbols 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 Application INFORMATION Before using the Genium X3 knee joint, please read these instructions for use thoroughly! Please follow your prosthetist's directions and observe the safety instructions carefully� The Genium X3 knee joint is intended exclusively for exoprosthetic fittings of the lower extremity� Conditions of Use The Genium X3 was designed for broad field of application and can be used by transfemoral am- putees as well as by active hip disarticulation amputees� For knee disarticulation amputees, a ver- sion for long residual limbs is available (3B5-X3=ST)� Please see the Technical Information section... - Page 4 CAUTION Use of unsuitable prosthetic components. If unsuitable prosthetic components are installed in the prosthesis, malfunction of the knee joint and a loss of functionality due to structural failure may occur� This can cause you to fall� The knee joint may only be combined with adapters and feet approved by Ottobock� Ottobock assumes no liability if the knee joint is used with prosthetic feet other than those specified� 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 can cause you to fall� • Any changes or modifications to the knee joint may limit its usability� • Opening and repairing of the knee joint may only be performed by authorised Ottobock personnel and the handling of the battery may only be carried out by Ottobock Service Centres (independent replacement is not permitted)� Please contact your prosthetist if you have any service questions� CAUTION Improper use of the remote control� Improper use may damage the remote control� This can lead to malfunction of the remote control and result in unexpected actions of the knee joint� This can cause you to fall� Please observe the information on the proper use of the remote control in the remote control section� CAUTION Transport damage. Mechanical impacts or stress during transportation of the knee joint, such as shocks and vibrations, can lead to: • Defects and resulting malfunctions of the knee joint� • Battery and hydraulic unit damage resulting in leaks� • Loss of functionality due to structural failure� This can cause you to fall and / or result in skin irritation�...
- Page 5 CAUTION Mechanical overloading. Exterior mechanical impacts or stress such as shocks and vibrations can lead to: • Short circuits in the electronics and battery, resulting in malfunction of the knee joint� • Defects of the battery and the hydraulic unit, resulting in leaks� • Loss of functionality due to structural failure� This can cause you to fall and / or result in skin irritation� Do not expose system components to mechanical vibrations or shocks� 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 per- manently� • 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 the section 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�...
- Page 6 CAUTION Overheating of the hydraulic unit� Extended, continuous use (e�g� lengthy downhill walks) can lead to: • Overheating of the hydraulic unit resulting in malfunction of the knee joint • Defects of the hydraulic unit resulting in leakage of liquid This can cause you to fall and / or result in skin irritation� Touching overheated components can also cause burns� Please take note of pulsating vibration signals� They indicate the risk of overheating� As soon as these pulsating vibrations begin, stop all activities and allow the hydraulic unit to cool down� You may resume your activities once the pulsating vibration signals stop� If activities are continued despite the pulsating vibration signals, there is the risk of overheating the hydraulic element and, in extreme cases, of damage to the knee joint� The knee joint should then be sent to an authorised Ottobock Service Centre for inspection� Please contact your prosthetist with any service questions� CAUTION Danger of falling when descending stairs. • When walking down stairs, the banister or handrail should always be used and the prosthetic foot should be placed on the step so that the heel (max� centre of the foot) is close to the edge of the step to facilitate rollover� • If the audible signal sounds, stop descending immediately and check whether stance phase con- trol is active (see Section “Safety Messages and Safety Mode“)� • Observe the vibration and audible signals (beeps) of the knee joint� • Particular caution is required when carrying children down stairs� CAUTION Improper MyMode switching. Incorrectly switching from MyModes into basic mode or vice versa results in a risk of falling (see the section MyMode Switching via remote control)! • After switching to one of the MyModes, check the functions since you may have accidentally activa- ted a different MyMode than you intended (see the section „MyMode Switching without the remote...
- Page 7 WARNING Danger of accidents when operating a motor vehicle. The ability of leg prosthesis wearers to operate a motor vehicle is determined on a case-by-case basis� Criteria include the type of fitting (amputation height, unilateral or bilateral, residual limb conditions, design of the prosthesis) and the individual abilities of the leg prosthesis wearer� Ensure you observe the applicable national laws for the operation of motor vehicles and have your driving ability examined and certified by an authorised agency for insurance purposes� In general, Ottobock recommends that vehicles should be professionally retrofitted to meet each user’s individual needs (e� g� automatic transmission)� Risk-free driving must be ensured even when the leg prosthesis is not functioning� CAUTION Malfunction of the knee joint. Malfunctions of the knee joint can cause you to fall� Observe the vibration signals and audible warnings (beep signals) of the knee joint� CAUTION Non-active safety mode. If safety mode can no longer be activated, there is a risk of falling� If the knee joint is no longer able to select safety mode (e�g� in case of short circuit caused by water penetration), the knee joint may have to be actively secured upon heel impact using the residual limb musculature until reaching a prosthetist or replacing the prosthesis� In this case, the prosthet- ist must be contacted promptly� CAUTION Risk of pinching in the flexion range area of the joint. Keep fingers / body parts away from this area when flexing the joint�...
- Page 8 Charging the knee joint INFORMATION Charging the knee completely before use is strongly recommended� INFORMATION Charging the battery is only possible at temperatures over 0 °C� Fully charging the battery in the knee joint takes approx� 6 - 8 hours� The better the connection between the charger and receiver on the knee joint (not interrupted e�g� by a sock), the shorter the charging time� CAUTION Charging the prosthesis without taking it off. During charging of the prosthesis the damp- ing characteristics of the knee joint change because the adjustable safety mode is activated� In certain situations, this can cause the user to fall� For safety reasons, take the prosthesis off before charging the battery� Connect the power cord to the charger with the correct polarity (Figure 1)� 1� Start the inductive charging process by connecting the charger to the receiver on the back of the knee joint� The charger is held in place by a magnet (Figure 2a / 2b)� Verify the battery capacity using the LEDs on the side (Figure 3) and the charging process based on the colour of the illu- minated ring (Figure 2b) (see tables below)� 2� End the inductive charging process by disconnecting the charger from the receiver� The knee joint performs a self-test and is then ready for operation, provided it is connected to the AXON Tube Adapter� This is indicated by a single vibration signal and beep� If this is not the case, an error has occurred� In that case please send the knee joint to your prosthetist or an authorised Ottobock Service Centre� INFORMATION After disconnecting the charger the knee joint will conduct a self test� Be sure not to move the knee joint during this brief self test, since it can cause an error� If you encounter this error, the problem can be corrected by reconnecting and then disconnecting the charger� INFORMATION Charging is not possible if the distance between the transmitter and receiver is greater than 2 mm� However, charging should proceed normally if, for example, a sock or Superskin between transmitter and receiver of the charger (also see the Charging Process table)�...
- Page 9 Charging Process Table Status Status LED Battery capacity indicator The power supply is connected, but the All five LEDs off Continuous green charger is not attached to the knee joint Charger connected to knee joint, good Display of the battery capacity Purple pulsing connection (green) (4-second cycle) according to the number of illuminated LEDs Charger connected to knee joint, bad Display of the battery capacity Weak purple connection (green) according to the number of illuminated LEDs a) Charger excess temperature a) 2nd and 4th LED illuminated Continuous b) Joint excess / insufficient temperature yellow� a) 1st, 3rd and 5th LED il- luminated c) Connection may be improved by reduc- The joint is not ing the distance between the charger and charged� c) 3rd LED illuminated (see the receiver section Charging the knee joint, Figure 3) Charger fault (error correction by discon- LEDs indicate an error code�...
-
Page 10: Sitting Function
INFORMATION When the knee joint is fully charged (all 5 LEDs at the side light up (Fig� 3)), the maximum period of use for the knee joint before the next charging process is up to 5 days, depending on patient activity� However, we recommend charging the knee joint every night� Functions in the Basic Mode INFORMATION Your prothetist can activate/deactivate settings using the X-Soft configuration software� Sitting function When a sitting position is maintained 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 both the flexion and extension directions� The sitting function can be activated by the prosthetist by using the X-Soft adjustment software� INFORMATION While sitting, the knee joint switches to an energy-saving mode� This energy-saving mode is acti- vated regardless of whether the Sitting function has been enabled or not� Intuitive Stance function The Intuitive Stance function automatically recognises any situation that puts strain on the prosthesis in the flexion direction but where flexion is not permitted� Examples where this is the case include standing on uneven or sloping surfaces� The joint is always locked in the flexion direction when the prosthetic leg is not fully extended, under some amount of load and at rest� When the load is taken off the leg or upon forward or backward rollover, the level of resistance is immediately reduced to stance phase resistance again� The knee joint is not locked when the above conditions are met and a sitting position is assumed (for example while driving)� The Intuitive Stance function can be activated by the prosthetist by using the X-Soft configuration software� Stairs and Obstacles function Negotiating stairs step-over-step: Although the Genium X3 is a passive knee joint, which means it cannot actively initiate movements, negotiating stairs step-over-step is possible� In order to do so, the prosthetic foot has to be placed on the next higher step first with the knee flexed� Then the hip is extended, which also extends the knee� This requires a sufficiently secure hold in the socket and a certain level of residual limb strength� During physiological stair climbing, knee... -
Page 11: Crossing Obstacles
be achieved via the mass inertia of the lower part of the leg� Immediately after lifting the extended leg off the floor, simultaneously extend the hip briefly and then abruptly flex it� This whip action flexes the knee� The knee joint recognises this movement sequence and sets flexion resistance to minimum� Without activation of this mode - i�e� with stance phase resistance - knee flexion would be limited and unpleasant pressure would be felt on the residual limb� The movement pattern is very similar to the physiological process if the toes extend below the next higher step at the beginning of the cycle� Here, too, the heel has to be pulled back first� Practice the “toes under the step” movement pattern with the sound side and with the prosthesis; then the complete movement pattern is intuitive and easy to learn� When sufficient knee flexion has been achieved, the knee joint increases extension resistance so that there is enough time to position the foot on the next step before the knee joint is extended again� The supporting area for the foot on the step has to be sufficient so that the heel does not extend back too far over the edge� With too little support area, the lower leg would extend too early and position the leg too far backwards� In this phase, the knee joint has already maximised the flexion resistance (that is, further flexion is blocked)� The knee joint can no longer be flexed but only extended� This ensures that the leg does not buckle if the hip strength is not sufficient for the extending motion� Support yourself with your hand on the contralateral side� A smooth wall is also sufficient for this purpose� This lateral support is intended to prevent the residual limb from twisting in the socket� Twisting can lead to unpleasant surface tension between the skin and the socket� Lateral support also improves your balance� When the knee joint is fully extended, the initial position has been reached� You can climb the next step or continue walking normally� Crossing obstacles: The stairs and obstacles function can be used to cross obstacles� Instead of achieving the required ground clearance of the prosthetic foot through lateral abduction of the extended leg, the whip action described above can be used� This is also possible from the walking motion� Take the weight off the prosthetic leg when the knee joint is extended and then perform the whip motion, which switches the knee joint to the stair and obstacle function� This delays the extension movement, giving enough time and ground clearance to step over an obstacle� The prosthetic leg will not be fully extended upon heel impact� An active knee joint would be required to achieve this� Since the knee joint is locked in the flexion direction during this phase, putting weight on it does not pose a hazard� You can then resume walking normally� The stairs and obstacles func- tion can be activated by the prosthetist using the X-Soft configuration software� Optimized Physiological Gait (OPG) function OPG minimizes the X3 user’s prosthetic deviations and promotes a more biomechanically correct gait pattern� There are no initiation or exit strategies that apply to OPG - it simply happens during the course of normal walking� Selection of this function enables the following features: (1) PreFlex (2) Adaptive Yielding Control (3) Dynamic Stability Control (DSC) (4) Stance Release on Ramps,... - Page 12 surfaces when PreFlex is present� PreFlex also allows users to ascend ramps in a more anatomically correct way by reducing the need for users to vault over a fully extended knee� (2) Adaptive Yielding Control The knee has an intelligent, auto adaptive control of stance flexion (max 17°) and extension move- ments, depending on the forces affecting the knee system� The varying stance flexion resistance experienced by the user is e�g� dependent on the behavior of the user, the surface condition and the angle of a slope or incline� (3) Dynamic Stability Control (DSC) DSC ensures the knee will not release stance resistance during biomechanically unstable static and dynamic conditions� Constantly checking multiple parameters, DSC ensures the optimally timed decision for the knee to safely switch from stance to swing� Because DSC is always monitoring knee function, multidirectional movement and walking backward are also possible without risk of stance resistance releasing� (4) Stance Release on Ramps Although flexed and partially loaded - the knee will release stance on hills and ramps to allow for greater knee flexion, improved swing phase clearance, and less hip flexion force needed to bring the shank into extension� (5) Adaptive Swing Phase Control Instantaneous adaptation to varied walking cadences and to changes of the pendular mass (i�g� varying footgear) ensures the knee always achieves the swing flexion target angle within (+/-) one degree� The swing extension and flexion resistance experienced by the user is autoadaptive� Enabling the OPG function: The OPG function can be activated by the prosthetist using the X-Soft configuration software� When this function is activated, both stance phase extension and swing phase extension are adjusted auto- matically� This means that the configurations in these areas are not necessary and the corresponding...
- Page 13 MyMode without the remote control is accomplished by bouncing on the forefoot at least three times within one second while maintaining ground contact and keeping the prosthetic leg extended� In doing so, the forefoot has to bear approx� 40 % of the total body weight at peak load and less than approx� 25 % of the body weight at the lowest load� However, the load may not be taken off the foot fully� 3 x in 1 second 1 second After the audible signal is emitted (one long beep and a long vibration signal), your weight needs to be taken off the prosthesis entirely for at least one second with the knee extended (no ground contact)� The knee joint then switches to the first MyMode and emits two short Beep and vibration signals� The procedure for switching to the second MyMode is similar, but by bouncing four times� In this case, the switch is indicated by three short Beep and vibration signals� Returning to basic mode from any MyMode is accomplished by bouncing at least three times� The switch is confirmed by a short Beep and vibration signal� If bouncing three times is activated but bouncing four times is not, any number of bounces greater than or equal to 3 switches to the first MyMode� CAUTION Improper MyMode switching. Incorrectly switching from MyModes into basic mode results in a risk of falling (see the section MyMode Switching via remote control)! • After switching to one of the MyModes, check the functions since you may have accidentally activa- ted a different MyMode than you intended (see the sections MyMode Switching without the remote control and MyMode Switching via remote control)� • Ensure that you switch back to basic mode once your activities in the MyMode have ended� CAUTION Feedback is disabled in mute mode. When the mute mode is active, no feedback will be given when switching into a MyMode or back to basic mode� If switching was unsuccessful, the behav- iour 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 to use the knee joint� INFORMATION Switching back to basic mode by bouncing three or more times cannot be deactivated� This means basic mode will be selected even if switching by bouncing was not activated in the X-Soft configuration software�...
-
Page 14: Remote Control
Remote control During normal operation, the knee joint can be used in basic mode (including 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 pa- rameters can also be adjusted with the remote control� CAUTION Improper MyMode switching using the remote control. MyMode switching using the remote control changes the cushioning properties of the knee joint� In certain situations, this can cause you to fall� You must stand securely when switching between modes and must carefully confirm whether the desired function was successfully set by the knee joint� CAUTION Penetration of water into the remote control. The remote control is not waterproof� Under ambient conditions where the remote control may get wet, using the supplied 4X194 Arm Band for protection is recommended� If water penetrates the remote control, the device may be dam- aged (warranty will become void)� This can lead to malfunction of the remote control, result in unexpected actions of the knee joint and cause you to fall� If penetrated by water, the remote control should be dried at room temperature for at least 1 day� Before using the remote control again, send it to an authorised Ottobock Service Centre� Please contact your prosthetist with any service questions� CAUTION Manipulation of the remote control. Any changes or modifications you make to the remote control on your own initiative can lead to malfunction and result in unexpected actions of the knee joint� This can cause you to fall�... - Page 15 INFORMATION The range of the remote control is max� 5 meter� Control Elements of the remote control 1� LCD screen 2� Enter button 3� Navigation keys: Left , right , up , down 4� Charging receptacle Initial Connection Between the remote control and the knee joint (Pairing) 1� Turn on the remote control by pressing the enter button� The start-up screen with the date, time and battery capacity of the remote control is displayed� Without additional input, the remote control turns off automatically after 5 seconds� 2� Attempt to establish a connection by pressing � The remote control searches for active prostheses� 3� When a knee joint is found (serial number is displayed), confirm by pressing the enter button� If several knee joints are found, the serial number of the desired knee joint has to be selected using the navigation keys (display: serial number)� Then the configuration data are downloaded from the knee joint�...
-
Page 16: Status Bar
Status Bar The status bar shows: 1� Battery capacity of the remote control 2� Charging state of the knee joint with percentage indicator 3� Current MyMode 4� In case of a deviation from normal knee joint functionality (e�g� when the charger is connected), an exclamation mark is shown in the status bar at the top right� The current MyMode is not displayed in some of these situations� MyMode Switching via remote control 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 confirm with the enter button� 2� A list of the available MyModes is displayed� Use to select the desired MyMode and confirm with the enter button� If the list of MyModes was called up accidentally, the active MyMode can be selected again� 3� The remote control can be turned off by selecting and confirming "RC Power off"� Changing Prosthesis Settings Once an active connection to the prosthesis has been established, the settings of the respective MyMode can be changed using the remote control� 1� Select “Device settings” from the main menu and confirm with the enter button� 2� A list of available parameters for the current MyMode is displayed� Select the desired parameter and confirm with the enter button�... -
Page 17: Basic Mode
5� The remote control can be turned off by selecting and confirming "RC Power off"� In order to change the settings of another MyMode, you first have to switch to that MyMode (see the section MyMode 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 with the help of the X-Soft configura- tion software� The remote control is not intended for use by the prosthetist in order to set up the knee joint� The behaviour of the prosthesis can be changed to a certain extent on a day-to-day basis using the remote control (e�g� while becoming accustomed to the prosthesis)� At the next appointment, the prosthetist can track the changes in the X-Soft configuration software� The table below shows the adjustment parameters for the individual 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 resistance 120 – 180 ±10 Resistance to flexion movements, e�g� while walking downstairs or sitting down in a chair� Swing phase - 55° – 70° ±3° Maximum flexion angle in the swing flexion angle phase�... - Page 18 Friction brake mode Slider name in X-Soft Absolute Range Remote control Description Adjustment Range Basis 0-180 ±20 Basic resistance for the knee joint without load Pitch 1000 Hz – 1000 Hz – Frequency (pitch) of the beeper for 4000 Hz 4000 Hz confirmation signals� Volume 0 – 4 0 – 4 Volume of the beeper for confirmation signals� Deep sleep mode The remote control can be used to place the knee joint in a deep sleep mode, in which power con- sumption is minimised� The knee joint offers no functionality in this mode� It can be awakened from deep sleep mode with the remote control or by connecting the charger� Proceed as follows to activate deep sleep mode: 1� Select „Device Settings“ in the main menu and confirm the selection� 2�...
-
Page 19: Mute Mode
Prosthesis Status Inquiry 1� Selecting and confirming “Status” displays the following: • The total pedometer value (“Step”) • The daily pedometer value (“Trip”) • The battery capacity of the prosthesis in percent (“Batt�”) • The estimated remaining operating time of the prosthesis in hours during active use and at rest (e�g� sitting function) („Stb/Act“ for Standby/Active) • The next service due date 2� Selecting "Trip" and pressing the selection key resets the day step counter� Mute Mode The remote control ca 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 an beep signals are disabled� In case of 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 you to fall�... - Page 20 4� The font size in the menu bar can be changed by selecting “Zoom”� 5� � 6� P ress on the screen to set the font to normal (1, ) or large (2, ) and then press the enter enter button to confirm� 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� Prosthesis Administration Connections with up to four different prostheses can be stored in a single remote control� Conversely, a prosthesis can only be connected to a single remote control� Complete the following steps to add additional connections: 1� Use to select "RC Settings" from the main menu and confirm using the enter button� 2� Select “Pairing” from the menu that appears� 3� The remote control searches for additional prostheses within range� 4� Use the enter button to confirm once another prosthesis has been 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)� Use to select one of the four positions and confirm with the enter button� 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� Use to select "RC Settings" from the main menu and confirm using the enter button� 2� In the menu that appears, select "Delete connection" and confirm using the enter button�...
-
Page 21: Charging The Remote Control
Connecting to the Prosthesis during Normal Operation If more than one connection has been saved, a selection menu for the saved connections appears after powering up; the most recently active connection is pre-selected here� 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� Charging the remote control Disconnect the charging cable from the charger of the knee joint and connect it to the charging receptacle on the remote control� Depending on how often the remote control is used, it should last two months on a single charge� The battery capacity of the remote control is shown at the top left of the display (see Figure 1 in the section Initial Connection between the remote control and knee joint (Pairing))� Fully charging the remote control battery takes a maximum of 3-4 hours� Genium X3 - Bionic Prosthetic System Ottobock | 21... - Page 22 Safety Messages and Safety Mode Symbols used: Charging status 25% short beep Charging signal status 10% Vibration signal Total failure or long beep charging sta- signal tus 0% continuous short vibration signal Hydraulic system every overheated 5 seconds long vibration signal Charger attached to Colours used: knee joint Information no action Using the Remote Control required Selected MyMode active...
- Page 23 Type of error Event User restriction Required action Minor error e�g� service interval has No restriction Consult Prosthetist expired e�g� a sensor (tube adapter, Restart the knee joint by triple sensor, ���) is not attaching and removing in- operating ductive charger (up to three Medium error times); If error remains, con- Selftest failure (if signals sult Prosthetist immediately occur after removing the charger) AXON Tube Adapter has Walking possible with been disconnected while the restrictions (activation knee joint is activated and of safety mode) the inductive charger is not AXON Connect the AXON Tube attached Tube Adapter Adapter AXON Tube Adapter not disconnected connected while removing...
-
Page 24: Battery Capacity
In addition, swing phase control and stance phase extension resistance may or may not be available depending on the type of error� If safety mode was triggered due to a empty battery (see Section “Charging the knee joint“), charg- ing the prosthesis resets it to basic mode� In this case, the resistance value configured in the X-Soft adjustment software is activated� There is also an overheating mode to protect the knee joint against excessive temperatures� In this safety mode, stance phase resistance increases as the temperature rises – especially in order to slow down walking downhill so that overheating is not allowed to worsen� Swing phase control is also progressively reduced� Overheating mode is indicated by brief vibration every 5 seconds� Basic mode is reactivated once the temperature has fallen sufficiently� CAUTION Feedback is disabled. When the mute mode is active, all vibration an beep signals are disabled� In case of low battery or system errors, the safety modes will be activated without warnings� If unexpected, this can cause you 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 you will fall� If the knee joint can no longer be set to safety mode, you 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 can cause you to fall� As soon as the sound and vibration signals are emitted simultaneously, stop all activities involving the leg prosthesis� After approx� 10 seconds in a secure standing position, determine whether stance phase resistance is active by repeatedly flexing the knee joint slightly under controlled load� CAUTION Safety mode cannot be deactivated. When the knee joint is in safety mode, this most likely indicates a knee joint defect� Malfunctions may occur in this state� This can cause you to fall�... -
Page 25: Cleaning And Care
Storage and Ventilation To store the knee joint, push the knee head to the flexion stop� Upon putting the knee joint back into use, hold it vertically with the knee head up and push the knee head to full extension� During extended non-vertical storage of the knee joint, air may accumulate in the hydraulics� This is noticeable through sounds and irregular damping behaviour� The automatic ventilation mechanism ensures that all functions of the knee joint are once again avail- able after approx� 10 - 20 steps� Cleaning and Care If the prosthesis is lightly soiled, clean it with a damp, soft cloth and mild soap (e�g� Ottobock 453H10=1 Derma Clean)� Afterwards, dry the prosthesis components with a soft, lint-free cloth� In case of extended, ongoing contact, liquids have a negative effect on the functionality of the prosthesis� This can cause leaks and therefore the failure of electronic components� If liquids come into contact with the prosthesis, they must not exceed 65 °C� After contact with shampoo or other liquids (e�g� beverages), rinse the prosthesis immediately and thoroughly with fresh water� Subsequently tilt the prosthesis so that accumulated liquid can drain� Allow the prosthesis to air dry at room temperature� The Genium X3 is resistant to abrasive surfaces (e�g� sand, grass, mud)� However, it may only be used in these environments to the extent that it can be easily cleaned by rinsing it with fresh water� Please note that the weight of dirt adhering to the prosthesis can affect the gait pattern� In case of heavy soiling that cannot be removed by rinsing, please contact your prosthetist� Service INFORMATION This component has been tested according to ISO 10328 standard for three million load cycles� Depending on the amputee‘s activity this corresponds to a duration of use of three to five years� The duration of use can be extended depending on the individual intensity of use by making use of regular service inspections (see 3B5-X3/3B5-X3=ST Service Pass 646D589=*)� In the interest of your own safety and in order to maintain operating safety and warranty, a service inspection is required after 12 months� This service inspection includes a verification of the sensors and the replacement of worn parts� For the service inspection, the Genium X3 knee joint with installed AXON tube adapter (2R19), remote control (4X350-X3) and complete charger (4E60) including power supply (757L16-*) and 3B5- X3/3B5-X3=ST Service Pass (646D589=*) must be sent to the authorised Ottobock Service Centre� Please contact your prosthetist well before the service inspection is due� Warranty Ottobock offers an extensive warranty service on the basis of the 3B5-X3/3B5-X3=ST service and warranty concept� Your prosthetist is the contact person� Genium X3 - Bionic Prosthetic System Ottobock | 25... -
Page 26: Technical Information
Technical Information Operating, storage and transport temperature with and -10 °C to +60 °C (14 °F to 140 °F) without packaging: 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: Li-Ion battery charging cycles (joint) (charging and discharg- ing cycles) after which at least 80% of the original battery capacity remains available: Knee joints Description 3B5-X3 3B5-X3=ST Proximal connection Pyramid adapter Threaded adapter Distal connection Tube clamp Weight without tube adapter 1710 g / 3,77 lbs Prox� system height to alignment 0 mm 26 mm reference point Minimum distal system height 298 mm With 2R19 AXON tube adapter Maximum distal system height 514 mm With 2R19 AXON tube adapter Knee flexion angle 135 °... -
Page 27: Use Of Symbols
AXON Tube Adapter Description 2R19 Weight 190-300 g / 0�42-0�66 lbs Material Aluminium Body weight max� 125 kg (275 lbs�) Waterproofness of the AXON tube IPX7, protected against water immersion but not against jets adapter of water or steam� Use of Symbols The meaning of the symbols on the product is explained below: This product must not be disposed of with regular domestic waste� Disposal that is not in accordance with the regulations of your country may have a detrimental impact on health and the environment� Please observe the information provided by the responsible authorities in your country regarding return and collection processes� Declaration of conformity according to the European Directive for Medical Devices 93/42/EEC and Radio Equipment 1999/5/EU Legal manufacturer In accordance with the requirements of “FCC Part 15” (USA) Non-ionising radiation Attention, hot surface Lot number Serial number of the device� Compliance with the requirements according to the “Radiocommunications Act” (AUS)� Genium X3 - Bionic Prosthetic System Ottobock | 27... - Page 28 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� The manufacturer is not liable for damage caused by component combinations that were not authorised by the manufacturer� 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� CE Conformity The Genium X3 3B5-X3/3B5-X3=ST 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 the guidelines� The Genium X3 3B5-X3/3B5-X3=ST knee joint also meets the requirements of Directive 1999/5/ EC for radio equipment and telecommunications terminal equipment� The conformity assessment was carried out by Ottobock according to Appendix I of the directive� A copy of the declaration of conformity can be requested from the manufacturer (see reverse)� 28 | Ottobock Genium X3 - Bionic Prosthetic System...
- Page 29 Genium X3 - Bionic Prosthetic System Ottobock | 29...
- Page 31 Kundenservice/Customer Service Europe Africa Asia/Pacific Otto Bock HealthCare Otto Bock Italia Srl Us Otto Bock Algérie E�U�R�L� Otto Bock Australia Pty� Ltd� Deutschland GmbH 40054 Budrio (BO) · Italy Mackle-Ben Aknoun Baulkham Hills NSW 2153 37115 Duderstadt · Germany T +39 (0) 051 692-4711 Alger · DZ Algérie Australia T +49 (0) 5527 848-3411 F +39 (0) 051 692-4710 T +213 (0) 21 913863 T +61 (0) 2 8818 2800 F +49 (0) 5527 848-1414 info�italia@ottobock�com F +213 (0) 21 913863 F +61 (0) 2 8814 4500 healthcare@ottobock�de information@ottobock�fr healthcare@ottobock�com�au Otto Bock Benelux B�V� Otto Bock Healthcare 5692 AK Son en Breugel Otto Bock Egypt S�A�E� Beijing Otto Bock Orthopaedic Products GmbH The Netherlands Mohandessein - Giza · Egypt Industries Co�, Ltd� 1070 Wien · Austria T +31 (0) 499 474585 T +202 (0) 330 24 390 Beijing, 100015, P�R� China T +43 (0) 1 5269548 F +31 (0) 499 476250...
- Page 32 Otto Bock Healthcare Products GmbH Kaiserstraße 39 · 1070 Wien · Austria T +43-1 523 37 86 · F +43-1 523 22 64 info�austria@ottobock�com · www�ottobock�com Ottobock has a certified Quality Management System in accordance with ISO 13485�...