Otto Bock Genium X3 3B5-2 User manual

Genium X3 3B5-2/3B5-2=ST
Instructions for use (qualified personnel) ................................................................. 5

DE | INFORMATION
Zusätzlich zu der gedruckten Gebrauchsanweisung, sind auch weitere Sprachen auf CD beigelegt (siehe rückseitigen Um
schlag). Auf Anfrage können Sie eine gedruckte Gebrauchsanweisung kostenlos in der jeweiligen Landessprache unter der un
ten angegebenen Anschrift bestellen.
EN | INFORMATION
In addition to the printed Instructions for Use, additional language versions are also included on CD (see back cover). You can
order a printed version of the Instructions for Use at no charge in the respective national language at the address below.
FR | INFORMATION
Le mode d‘emploi est disponible en d‘autres langues sur CD en supplément de la version imprimée (voir au dos de la couver
ture). Vous pouvez commander gratuitement une version imprimée du mode d‘emploi dans la langue de votre choix en envoyant
votre demande à l‘adresse indiquée ci-dessous.
ES | INFORMAĆION
Aparte de las instrucciones de uso impresas, se incluye un CD con dichas instrucciones en otros idiomas (véase la solapa del
dorso). Puede solicitar de forma gratuita unas instrucciones de uso impresas en el idioma de su país a la dirección que se indi
ca más abajo.
IT | INFORMAZIONE
In aggiunta alle istruzioni per l‘uso in formato cartaceo, il CD contiene le istruzioni anche in altre lingue (vedere il retro della co
pertina). Su richiesta, potete ordinare gratuitamente le istruzioni per l‘uso in formato cartaceo nella relativa lingua del vostro
Paese all‘indirizzo di seguito riportato.
PT | INFORMAÇÃO
Adicionalmente ao manual de utilização impresso encontra-se incluído um CD com mais idiomas (consultar a contracapa). A
pedido é possível encomendar gratuitamente um exemplar impresso do manual de utilização no respectivo idioma junto do
endereço especificado.
NL | INFORMATIE
De gebruiksaanwijzing is behalve in gedrukte vorm ook in diverse andere talen bijgevoegd op cd (zie de achterzijde van de oms
lag). Een gedrukte gebruiksaanwijzing in de gewenste taal kunt u kosteloos bestellen op het hieronder vermelde adres.
SE | INFORMATION
Som komplement till den tryckta bruksanvisningen har dessutom ytterligare språk bifogats på CD (se baksidan av omslaget).
Vid efterfrågan kan du utan kostnad beställa en tryckt bruksanvisning i det respektive språket under den angivna adressen.
DA | INFORMATION
Supplerende til brugsanvisningen på papir er der også vedlagt yderligere sprog på cd (se bagsiden af omslaget). På den oplys
te adresse nedenfor kan du bestille en gratis brugsanvisning på papir på det pågældende sprog.
NO | INFORMASJOU
I tillegg til den trykte bruksanvisningen er flere språk vedlagt på CD (se på baksiden omslaget). Ved forespørsel kan du bestille
en gratis trykt bruksanvisning i det gjeldende språket via adressen nedenfor.
FI | TIEDOT
Painetun käyttöohjeen lisäksi tarjoaa oheinen CD-levy käyttöön myös lisää kieliä (katso kansilehden takapuoli). Painettu käyt
töohje kunkin maan omalla kielellä on pyynnöstä tilattavissa maksutta alla ilmoitetusta osoitteesta.
CZ | INFORMACE
Kromě této vytištěné verze návodu k použití jsou na přiloženém CD k dispozici také další jazykové verze překladu (viz zadní stra
na obalu). V případě požadavku si můžete na níže uvedené adrese zdarma objednat vytištěný návod k použití v příslušném jazy
ce.
PL | INFORMACJA
Dodatkowo do wydrukowanej instrukcji użytkowania dołączono na CD wersję w innych językach (patrz tył okładki). Na żądanie
istnieje możliwość zamówienia bezpłatnie pod podanym poniżej adresem wydrukowanej instrukcji użytkowania w języku danego
kraju.
SK | INFORMÁCIA
Dodatočne ku vytlačenému návodu na používanie sú na CD uložené aj ďalšie jazyky (pozri zadnú obálku). Na požiadanie si
môžete bezplatne objednať vytlačený návod na používanie v príslušnom jazyku krajiny na dole uvedenej adrese.
HU | INFORMATION
A kinyomtatott használati utasítást kiegészíti a további nyelveket tartalmazó, mellékelt CD (ld. a hátlapon lévő borítékot). Az
alábbi címen, kérésre költségmentesen megrendelhet az adott ország nyelvén kinyomtatott használati utasítást.
HR | INFORMACIJA
Dodatno uz tiskane upute za uporabu priloženi su i drugi jezici na CD-u (vidi poleđinu). Na upit možete na dolje navedenoj adre
si besplatno naručiti tiskane upute za uporabu na dotičnom jeziku.
2 Genium X3 3B5-2/3B5-2=ST

TR | INFORMATION
Basılmış olan kullanım kılavuzuna ilave olarak CD'de daha fazla alternatif diller bulunmaktadır (bakınız zarfın arka yüzü). İstek
üzerine ilgili dilde basılmış kullanım kılavuzunu aşağıda belirtilmiş olan adresten temin edebilirsiniz.
Ottobock Healthcare Products GmbH
Brehmstraße 16 | 1110 Wien | Austria
[email protected] | Fax [phone]
3Genium X3 3B5-2/3B5-2=ST

4 Genium X3 3B5-2/3B5-2=ST

Important information1 8........................................................................................................................................
Foreword2 9..............................................................................................................................................................
Product description3 9............................................................................................................................................
Design3.1 9.................................................................................................................................................
Function3.2 9..............................................................................................................................................
Combination possibilities3.3 10.....................................................................................................................
Combination with an osseointegrated implant system3.3.1 10..............................................................................
Application4 10.........................................................................................................................................................
Indications for use4.1 10...............................................................................................................................
Area of application4.2 10..............................................................................................................................
Conditions of use4.3 11................................................................................................................................
Indications4.4 11.........................................................................................................................................
Qualification4.5 11.......................................................................................................................................
Safety5 12..................................................................................................................................................................
Explanation of warning symbols5.1 12............................................................................................................
Structure of the safety instructions5.2 12........................................................................................................
General safety instructions5.3 12...................................................................................................................
Information on the Power Supply/Battery Charging5.4 14.................................................................................
Battery charger information5.5 15..................................................................................................................
Information on Alignment/Adjustment5.6 15....................................................................................................
Information on Proximity to Certain Areas5.7 17...............................................................................................
Information on Use5.8 17..............................................................................................................................
Notes on the safety modes5.9 19...................................................................................................................
Instructions for use with an osseointegrated implant system5.10 19.....................................................................
Information on the use of a mobile device with the cockpit app5.11 19.................................................................
Scope of Delivery and Accessories6 20................................................................................................................
Charging the battery7 21.........................................................................................................................................
Connecting the power supply and battery charger7.1 21..................................................................................
Charging the prosthesis battery7.2 21............................................................................................................
Display of the current charge level7.3 22.........................................................................................................
Display of battery charge level without additional devices7.3.1 22.........................................................................
Display of the current charge level using the Cockpit app7.3.2 22........................................................................
Display of current charge level using remote control (optional accessory)7.3.3 22..................................................
Display of the current charge level during the charging process7.3.4 22................................................................
Preparation for use8 23...........................................................................................................................................
Alignment8.1 23...........................................................................................................................................
Settings with the "X-Soft" adjustment software8.1.1 23.......................................................................................
Introduction8.1.1.1 23........................................................................................................................................
Data transfer between the product and the PC8.1.1.2 23.......................................................................................
Preparing the product to connect to the adjustment software8.1.1.3 23....................................................................
Shortening the Tube Adapter8.1.2 24................................................................................................................
Installing the Tube Adapter8.1.3 24...................................................................................................................
Bench alignment in alignment apparatus8.1.4 24................................................................................................
Static alignment optimisation8.1.5 25................................................................................................................
Dynamic alignment optimisation8.1.6 25............................................................................................................
Torque values of the screw connections8.1.7 25.................................................................................................
Checking the socket after bench alignment8.1.8 25............................................................................................
Flexion stop8.1.9 26........................................................................................................................................
Cockpit app9 27........................................................................................................................................................
System Requirements9.1 27..........................................................................................................................
Initial connection between cockpit app and prosthesis9.2 27.............................................................................
Starting the cockpit app for the first time9.2.1 27................................................................................................
Table of contents
5Genium X3 3B5-2/3B5-2=ST
Table of contents

Control elements for cockpit app9.3 28..........................................................................................................
Cockpit app navigation menu9.3.1 29...............................................................................................................
Managing components9.4 29........................................................................................................................
Adding component9.4.1 29..............................................................................................................................
Deleting a component9.4.2 30..........................................................................................................................
Connecting component with multiple devices9.4.3 30.........................................................................................
Use10 30......................................................................................................................................................................
Movement patterns in basic mode (mode 1)10.1 30...........................................................................................
Standing10.1.1 30............................................................................................................................................
Stance function10.1.1.1 30...................................................................................................................................
Walking10.1.2 31.............................................................................................................................................
Running short distances ("walk-to-run" function)10.1.3 31.....................................................................................
Sitting down10.1.4 31.......................................................................................................................................
Sitting10.1.5 32................................................................................................................................................
Sitting function10.1.5.1 32...................................................................................................................................
Standing up10.1.6 32.......................................................................................................................................
Walking up stairs step-over-step10.1.7 32...........................................................................................................
Overcoming obstacles10.1.8 33.........................................................................................................................
Walking down stairs10.1.9 34............................................................................................................................
Walking down a ramp10.1.10 34..........................................................................................................................
Changing prosthesis settings10.2 34...............................................................................................................
Changing the prosthesis setting using the cockpit app10.2.1 35............................................................................
Overview of adjustment parameters in basic mode10.2.2 35..................................................................................
Overview of adjustment parameters in MyModes10.2.3 36.....................................................................................
Turning Bluetooth on the prosthesis on/off10.3 37.............................................................................................
Switching Bluetooth off/on using the cockpit app10.3.1 37....................................................................................
Querying the prosthesis status10.4 37..............................................................................................................
Query status through cockpit app10.4.1 37.........................................................................................................
Status display in the cockpit app10.4.2 37...........................................................................................................
Status information on the display of the remote control (optional accessory)10.4.3 37...............................................
Mute mode (silent mode)10.5 38.....................................................................................................................
Turning mute mode on/off using the Cockpit app10.5.1 38....................................................................................
Turning mute mode on/off using the remote control10.5.2 38.................................................................................
Deep sleep mode10.6 38................................................................................................................................
Turning deep sleep mode on/off using the Cockpit app10.6.1 38...........................................................................
Turning deep sleep mode on/off using the remote control10.6.2 39........................................................................
OPG function (Optimised Physiological Gait)10.7 39.........................................................................................
MyModes11 40............................................................................................................................................................
Running function as configured MyMode11.1 40...............................................................................................
Switching MyModes with the cockpit app11.2 40..............................................................................................
Switching MyModes using motion patterns11.3 41............................................................................................
Switching from a MyMode back to basic mode11.4 42.......................................................................................
Additional operating states (modes)12 42..............................................................................................................
Empty battery mode12.1 42.............................................................................................................................
Mode for charging the prosthesis12.2 42..........................................................................................................
Safety mode12.3 43.......................................................................................................................................
Overheating mode12.4 43...............................................................................................................................
Storage and bleeding13 43.......................................................................................................................................
Cleaning14 43.............................................................................................................................................................
Maintenance15 44......................................................................................................................................................
Identification of the product by the Service Center15.1 44..................................................................................
Legal information16 44..............................................................................................................................................
Liability16.1 44..............................................................................................................................................
Trademarks16.2 44........................................................................................................................................
CE Conformity16.3 45....................................................................................................................................
6 Genium X3 3B5-2/3B5-2=ST
Table of contents

Local Legal Information16.4 45.......................................................................................................................
Technical data17 46...................................................................................................................................................
Appendices18 48........................................................................................................................................................
Symbols Used18.1 48....................................................................................................................................
Operating states/error signals18.2 49..............................................................................................................
Signals for operating states18.2.1 49..................................................................................................................
Warnings/error signals18.2.2 49........................................................................................................................
Error messages while establishing a connection with the cockpit app18.2.3 51........................................................
Status signals18.2.4 51.....................................................................................................................................
7Genium X3 3B5-2/3B5-2=ST
Table of contents

1 Important information
INFORMATION
Remote control function only possible with version 1.0.0.6 or above
Please note that you can only use this and/or the updated knee joint with the 4X350-X3 remote control in ver
sion 1.0.0.6 or higher.
Therefore, check the version of the remote control as follows:
►With the remote control switched on, use the and keys to select the menu option RC settings and con
firm with the key.
►Use the and keys to select the menu option Info and confirm this with the key.
►Use the and keys to select the RC version: 1.0.0.4menu option. If an older version appears than 1.0.0.6,
the remote control must be updated by an authorised Ottobock Service Centre.
The function of the remote control with this or the updated knee joint is only possible with version
1.0.0.6 or higher.
8 Genium X3 3B5-2/3B5-2=ST
Important information

2 Foreword
INFORMATION
Date of last update: 2017-03-13
►Please read this document carefully before using the product.
►Instruct the user in the proper and safe use of the product.
►Please contact the manufacturer if you have questions about the product (e.g.regarding the start-up, use,
maintenance, unexpected operating behaviour or circumstances). Contact information can be found on the
back page.
►Please keep this document in a safe place.
The product "Genium" is called the product/prosthesis/knee joint/component in the following.
These instructions for use provide you with important information on the use, adaptation and handling of the
product.
Only put the product into use in accordance with the information contained in the accompanying documents sup
plied.
3 Product description
3.1 Design
The product consists of the following components:
87654321
1. Proximal pyramid adapter
2. Optional flexion stops
3. Battery
4. Hydraulic unit
5. LED (blue) as indicator for the Bluetooth connec
tion
6. Receiver of the inductive charging unit
7. Distal tube clamp screws (covered by protector)
8. Connecting cable for tube adapter
3.2 Function
This product features microprocessor control of the stance and swing phase.
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.
Thanks to the microprocessor-controlled stance and swing phase, the system can be individually adapted to the
needs of the patient.
For this purpose, the product is configured with the X-Soft adjustment software.
The product features MyModes for special motion types (e.g. cross-country skiing, ...). These are preconfigured
using the adjustment software and can be accessed by means of special motion patterns, the cockpit app and the
remote control (optional accessory) (see Page40).
In case of a system malfunction, safety mode makes restricted operation possible. Predefined resistance paramet
ers are configured in the product for this purpose (see Page43).
Empty battery mode permits safe walking when the battery is drained. Resistance parameters that are predefined
by the product are configured for this purpose (see Page42).
9Genium X3 3B5-2/3B5-2=ST
Foreword

The microprocessor-controlled hydraulic unit offers the following advantages
• Approximation of the physiological gait pattern
• Stability while standing and walking
• Adaptation of product characteristics to various surfaces, inclines, gait situations and walking speeds
3.3 Combination possibilities
This product can be combined with the following Ottobock components:
Adapters
• 4R104=60 double adapter, sliding
• 4R104=75 double adapter, sliding
• 4R57, 4R57=ST rotation adapter
• 4R41 lamination anchor with pyramid receiver
• 4R43 lamination anchor with threaded connector
• 4R89 lamination anchor with pyramid adapter
• 4R111=N lamination anchor with threaded connect
or
• 4R111 lamination anchor with pyramid receiver
• 4R116 lamination anchor with pyramid adapter
• Lamination anchor with pyramid receiver and
angled arm: 4R119
• 4R40 torsion adapter
• 4R118 adapter plate
Tube adapter
• AXON tube adapter: 2R19
Cosmetic cover/protector
• Genium X3 Protective Cover: 4X900
• Genium X3 Protective Cover: 4X193-1
Prosthetic feet
The maximum allowable patient weight depends on the foot size.
• 1C30 Trias
• 1D35 Dynamic Motion
• 1C40 C-Walk
• 1C60 Triton
• 1C61 Triton Vertical Shock
• 1C62 Triton Harmony
• 1C63 Triton Low Profile
• 1C64 Triton Heavy Duty
• 1E56 Axtion
• 1E57 Lo Rider
• Challenger: 1E95
• 1B1 Meridium
• 1C66 Triton smart ankle • 1C10 Terion
3.3.1 Combination with an osseointegrated implant system
This product can be connected to a socket or to an osseointegrated, percutaneous implant system.
In case of connection to an implant system, verify that the manufacturer of the implant system and the manufactur
ers of the corresponding exoprosthetic components/adapters also permit this combination. It must be ensured that
all indications/contraindications, the field of application, the conditions of use and all safety instructions are com
plied with for the implant system, corresponding exoprosthetic components, corresponding adapters and for the
knee joint.
Among other things, this relates to the body weight, mobility grade, type of activity, load capacity of the implant and
bone anchoring, freedom from pain under functional load and compliance with the permissible ambient conditions
(see Page46).
Please ensure that the qualified personnel applying the product is not only authorised for fitting this knee joint, but
also for the connection to the osseointegrated implant system.
4 Application
4.1 Indications for use
The product is to be used solely for lower limb exoprosthetic fittings.
4.2 Area of application
Area of application according to Ottobock’s MOBIS classification:
10
Application
Genium X3 3B5-2/3B5-2=ST

°
kg
The product is recommended for mobility grade3 (unrestricted outdoor walker) and mobility
grade4 (unrestricted outdoor walker with particularly high demands). Approved for a body
weight of up to 125kg(275 lbs).
4.3 Conditions of use
The product was developed for everyday use and must not be used for unusual activities. These unusual activities
include, for example, extreme sports (free climbing, parachuting, paragliding, etc.).
Permissible ambient conditions are described in the technical data (see Page46).
The product is intended exclusively for use on one patient. Use of the product by another person is not approved
by the manufacturer.
4.4 Indications
• For patients with knee disarticulation, transfemoral amputation and hip disarticulation (patients with hip disar
ticulation or hemipelvectomy must be fitted with the 7E10=* Helix3D hip joint).
• For unilateral or bilateral amputation
• Dysmelia patients with residual limb characteristics corresponding to knee disarticulation, transfemoral ampu
tation or hip disarticulation
• The patient must fulfil the physical and mental requirements for perceiving visual/acoustic signals and/or mech
anical vibrations.
4.5 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.
11Genium X3 3B5-2/3B5-2=ST
Application

5 Safety
5.1 Explanation of warning symbols
WARNING Warning regarding possible serious risks of accident or injury.
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
5.2 Structure of the safety instructions
CAUTION
The heading describes the source and/or the type of hazard
The introduction describes the consequences in case of failure to observe the safety instructions. Consequences
are presented as follows if more than one consequence is possible:
> E.g.: Consequence 1 in case of failure to observe the hazard
> E.g.: Consequence 2 in case of failure to observe the hazard
►This symbol identifies activities/actions that must be observed/carried out in order to avert the hazard.
5.3 General safety instructions
WARNING
Non-observance of safety instructions
Injury due to damage or unexpected product behaviour.
►Follow the safety instructions and the precautions specified in this accompanying document.
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 conditions.
►Immediately replace damaged power supply units, adapter plugs or battery chargers.
CAUTION
Failure to observe warning/error signals
Falling due to unexpected product behaviour because of changed damping behaviour.
►The warnings/error signals (see Page49) and corresponding change in damping settings must be observed.
CAUTION
Failure to observe activated mute mode (silent mode)
Falling due to unexpected product behaviour because of changed damping behaviour.
The following feedback signals are deactivated when mute mode is activated:
> Long vibration signal if the hydraulic unit overheats.
> Beep and vibration signal to confirm that the movement pattern has been recognised (switching to a
MyMode/basic mode with movement pattern).
> Beep and vibration signal to indicate successful switching to a MyMode/basic mode.
> Beep and vibration signal upon successfully switching to deep sleep mode.
►Before activating mute mode, note that these feedback signals will be deactivated. For more information
about mute mode, see the section "Mute mode" (see Page38).
►Inform the patient that the changed damping characteristics have to be verified after switching to a
MyMode/basic mode.
►Ensure that the patient stands securely during all switching processes.
►To deactivate mute mode, connect and then disconnect the battery charger.
12
Safety
Genium X3 3B5-2/3B5-2=ST

CAUTION
Independent user manipulation of system components
Falling due to breakage of load-bearing components or malfunction of the product.
►Manipulations to the product other than the tasks described in these instructions for use are not permitted.
►The battery may only be handled by Ottobock authorised, qualified personnel (no replacement by the user).
►The product and any damaged components may only be opened and repaired by authorised, qualified
Ottobock personnel.
CAUTION
Mechanical stress on the product
> Falling due to unexpected product behaviour as the result of a malfunction.
> Falling due to breakage of load-bearing components.
> Skin irritation due to defects on the hydraulic unit with leakage of liquid.
►Do not subject the product to mechanical vibrations or impacts.
►Check the product for visible damage before each use.
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 due to ageing of
the battery.
CAUTION
Risk of pinching in the joint flexion area
Injuries due to pinching of body parts.
►Ensure that fingers/body parts or soft tissue of the residual limb are not in this area when bending the joint.
CAUTION
Penetration of dirt and humidity into the product
> Falling due to unexpected product behaviour as the result of a malfunction.
> Falling due to breakage of load-bearing components.
►Ensure that no solid particles or foreign objects can penetrate into the product.
►The knee joint and AXON tube adapter are waterproof and resistant to corrosion. The knee joint and AXON
tube adapter can be operated in fresh and salt water. Do not use the knee joint under extreme conditions like
diving or jumping into water. The knee joint and AXON tube adapter are designed for underwater use (for the
maximum duration and water depth, see the section "Technical data" (see Page46).
►After contact with water, hold the prosthesis with the sole of the foot facing up until the water has drained
from the knee joint and AXON tube adapter.
►After using the knee joint in a salt water environment, remove the Protective Cover and rinse knee joint, AXON
tube adapter and Protective Cover with fresh water. Dry the knee joint and components with a lint-free cloth
and allow the components to fully air dry.
►Should the knee joint or AXON tube adapter come into contact with solutions other than fresh or salt
water, promptly remove the Protective Cover and clean the knee joint. In order to do so, rinse knee joint,
AXON tube adapter and Protective Cover with fresh water and let them dry.
►In case of a malfunction after drying, the knee joint and AXON tube adapter must be inspected by an author
ised Ottobock Service Center.
►The knee joint and the AXON tube adapter are not protected against the penetration of jets of water and
steam.
13Genium X3 3B5-2/3B5-2=ST
Safety

CAUTION
Use of the product without protector or with damaged protector
> Falling due to unexpected product behaviour as the result of malfunction.
> Falling due to breakage of load-bearing components.
►If the protector has been removed, ensure prior to the next use of the product that the protector has been
properly installed.
►Using the product with a damaged protector or without the protector is not permitted.
►Using the product with a foam cover is not possible, since the protector would have to be removed for this
purpose.
CAUTION
Mechanical stress during transport
> Falling due to unexpected product behaviour as a result of a malfunction.
> Falling due to breakage of load-bearing components.
> Skin irritation due to defects on the hydraulic unit with leakage of liquid.
►Only use the transport packaging for transportation.
CAUTION
Signs of wear to system components
Falling due to damage or malfunction of the product.
►In the interest of the patient's safety and in order to maintain operating reliability, the product should be ser
viced at regular intervals.
NOTICE
Improper product care
Damage to the product due to the use of incorrect cleaning agents.
►Clean the product with a damp cloth only (fresh water).
►Only use fresh water with a temperature of no more than 65°C for cleaning.
►If dirt cannot be removed, the product has to be sent to an authorised Ottobock Service Centre.
INFORMATION
Knee joint movement noise
When using exoprosthetic knee joints, servomotor, hydraulic, pneumatic or brake load dependent control func
tions can cause movement noise. This kind of noise is normal and unavoidable. It generally does not indicate any
problems. If movement noise increases noticeably during the lifecycle of the knee joint, the knee joint should be
inspected by an authorised Ottobock Service Centre immediately.
5.4 Information on the Power Supply/Battery Charging
CAUTION
Charging the product without taking it off
Falling due to unexpected product behaviour because of changed damping behaviour.
►Instruct the patient that the product must be taken off before it is charged.
CAUTION
Charging the product with damaged power supply unit/charger/charger cable
Falling due to unexpected behaviour of the product caused by insufficient charging.
►Check the power supply unit, charger and charger cable for damage before use.
►Replace any damaged power supply unit, charger or charger cable.
14
Safety
Genium X3 3B5-2/3B5-2=ST

NOTICE
Use of incorrect power supply unit/battery charger
Damage to product due to incorrect voltage, current or polarity.
►Use only power supply units/battery chargers approved for this product by Ottobock (see instructions for use
and catalogues).
5.5 Battery charger information
NOTICE
Penetration of dirt and humidity into the product
Lack of proper charging functionality due to malfunction.
►Ensure that neither solid particles nor liquids can penetrate into the product.
NOTICE
Mechanical stress on the power supply/battery charger
Lack of proper charging functionality due to malfunction.
►Do not subject the power supply/battery charger to mechanical vibrations or impacts.
►Check the power supply/battery charger for visible damage before each use.
NOTICE
Operating the power supply unit/charger outside of the permissible temperature range
Lack of proper charging functionality due to malfunction.
►Only use the power supply unit/charger for charging within the allowable temperature range. The section
"Technical data" contains information on the allowable temperature range (see Page46).
NOTICE
Independent changes or modifications carried out to the battery charger
Lack of proper charging functionality due to malfunction.
►Have any changes or modifications carried out only by Ottobock authorised, qualified personnel.
NOTICE
Contact of the battery charger with magnetic data storage devices
Wiping of the data storage device.
►Do not place the battery charger on credit cards, diskettes, audio or video cassettes.
5.6 Information on Alignment/Adjustment
CAUTION
Use of unsuitable prosthetic components
Falling due to unexpected behaviour of the product or breakage of load-bearing components.
►Use the product only in combination with components listed in the section "Combination possibilities" (see
Page10).
►If the product is to be used in water, verify that each prosthetic component is waterproof.
CAUTION
Improper assembly of the screw connections
Falling due to breakage or loosening of the screw connections.
►Clean the threads before every installation.
►Apply the specified installation torque values.
►Observe the instructions for securing the screw connections and the use of the correct length.
15Genium X3 3B5-2/3B5-2=ST
Safety

CAUTION
Incorrect alignment or assembly
Falling due to damage to the prosthesis components.
►Observe the alignment and assembly instructions.
CAUTION
Errors during prosthesis alignment
> Falling due to unexpected product behaviour as the result of a malfunction.
> Falling due to breakage of load-bearing components.
►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 extension (reached under full load), it is essential to maintain a minimum distance of 5mm (1/4")
between the sealing sleeve/top edge of the installed Protective Cover and the socket.
►If there is contact between the socket and the joint (hydraulic unit, frame) at maximum flexion, then the joint
must be fitted with a flexion stop (e.g. in the case of voluminous residual limbs).
If contact between the socket and joint (hydraulic unit, frame) occurs anyway at maximum flexion, the socket
has to lie flat on the frame (with the help of soft padding on the socket).
CAUTION
Insufficient insertion depth of the tube adapter
Falling due to breakage of load-bearing components.
►Insert the tube adapter at least 40mm to ensure operational safety.
►The patient must be seated for length adjustments.
CAUTION
Operator errors during the adjustment process with the adjustment software
Falling due to unexpected prosthesis behaviour.
►Do not charge the prosthesis battery during the configuration process since the prosthesis is not functional
while the battery is being charged.
►The prosthesis must not remain unattended during the configuration process while connected to the adjust
ment software and being worn by the patient.
►Observe the maximum range of the Bluetooth connection and take note that obstacles may limit this range.
►During the data transfer (PC to prosthesis) the prosthesis wearer should sit still or stand securely, and the
BionicLink PC must not be removed from the computer.
►If only temporary changes to the settings are to be made while connected to the adjustment software, these
changes must be reversed before the adjustment software is closed.
It must also be ensured that the patient does not leave the range of the Bluetooth connection with settings that
have been changed temporarily.
►Inform the patient immediately if the data connection is accidentally interrupted during the configuration pro
cess.
►The connection to the prosthesis must always be disconnected after adjustments have been completed.
►Participation in an Ottobock product training course is mandatory prior to the initial use of the product. Addi
tional product training courses may be required to qualify for software 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 switch to the swing phase. If the values
are too low, the prosthesis may trigger the swing phase at the wrong time.
►If the patient uses walking aids (e.g. crutches or walking canes) during the adjustment process, readjustment
is required as soon as the patient stops using these walking aids.
►Use the online help which is integrated into the software.
►Do not pass on your personal access data.
16
Safety
Genium X3 3B5-2/3B5-2=ST

CAUTION
Safety mode flexion resistance set too low
Falling due to unexpected product behaviour as the result of switching into safety mode.
►Safety mode flexion resistance should be configured so that it is possible to stand safely without the knee joint
buckling.
5.7 Information on Proximity to Certain Areas
CAUTION
Distance to HF communication devices is too small (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 the following minimum distances to these HF communication devices is recommended:
• Mobile phone GSM 850/GSM 900: 0.50m
• Mobile phone GSM 1800/GSM 1900/UMTS: 0.35 m
• DECT cordless phones incl. base station: 0.18 m
• WiFi (routers, access points,…): 0.11 m
• Bluetooth devices (third-party products not approved by Ottobock): 0.11 m
CAUTION
Proximity to sources of strong magnetic or electrical interference (e.g. theft prevention systems, metal
detectors)
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
►Ensure that the patient is not in the vicinity of sources of strong magnetic and electrical interference during tri
al fitting (such as theft prevention systems, metal detectors...).
If this cannot be avoided, ensure at least that the patient has a safeguard when walking or standing (e.g. a
handrail or the support of another person).
CAUTION
Entering a room or area with strong magnetic fields (e.g. magnetic resonance tomographs, MRT (MRI)
equipment...)
> Falling due to unexpected restriction of the product's range of motion caused by metallic objects adhering to
the magnetised components.
> Irreparable damage to the product due to the effect of strong magnetic fields.
►Make sure that the patient takes off the product before entering the room or area and stores the product out
side this room or area.
►Damage to the product caused by exposure to strong magnetic fields cannot be repaired.
CAUTION
Remaining in areas outside the allowable temperature range
Falling due to malfunction or the breakage of load-bearing product components.
►Ensure that the patient is not in areas outside the permissible temperature range (see Page46) during trial fit
ting.
5.8 Information on Use
CAUTION
Walking up stairs
Falling due to foot being placed incorrectly on stair as a result of changed damping behaviour.
►Inform the patient that the handrail always has to be used when walking up stairs, and that most of the sole of
the foot has to be set onto the stair surface.
►Particular caution is required when carrying children up the stairs.
17Genium X3 3B5-2/3B5-2=ST
Safety

CAUTION
Walking down stairs
Falling due to foot being placed incorrectly on stair as a result of changed damping behaviour.
►Inform the patient that the handrail always has to be used when walking down stairs, and that the patient has
to roll over the edge of the step with the middle of the shoe.
►The warnings and error signals have to be observed (see Page49).
►Notify the patient that resistance in the flexion and extension direction can change in case of warnings and
error signals.
►Particular caution is required when carrying children down the stairs.
CAUTION
Overheating of the hydraulic unit due to uninterrupted, increased activity (e.g. extended walking down
hill)
> Falling due to unexpected behaviour of the product because of switching into overheating mode.
> Burns due to touching overheated components.
►Be sure to pay attention when pulsating vibration signals start. They indicate the risk of overheating.
►As soon as these pulsating vibration signals begin, the activity level has to be reduced so the hydraulic unit
can cool down.
►Full activity may be resumed after the pulsating vibration signals stop.
►If the activity level is not reduced in spite of the pulsating vibration signals, this could lead to the hydraulic ele
ment overheating and, in extreme cases, cause damage to the product. In this case, the product should be
inspected by an authorised Ottobock Service Centre.
CAUTION
Overloading due to unusual activities
> Falling due to unexpected product behaviour as the result of malfunction.
> Falling due to breakage of load-bearing components.
> Skin irritation due to defects on the hydraulic unit with leakage of liquid.
►The product was developed for everyday use and must not be used for unusual activities. These unusual activ
ities include, for example, extreme sports (free climbing, paragliding, etc.).
►Careful handling of the product and its components not only increases their service life but, above all, ensures
the patient's personal safety!
►If the product and its components have been subjected to extreme loads (e.g. due to a fall, etc.), then the
product must be inspected for damage immediately. If necessary, forward the product to an authorised
Ottobock Service Centre.
CAUTION
Improper mode switching
Falling due to unexpected behaviour of the product because of changed damping behaviour.
►Ensure that the patient stands securely during all switching processes.
►Inform the patient that the changed damping characteristics have to be verified after switching and feedback
from the acoustic signal emitter must be observed.
►Switching back to basic mode is mandatory once the activities in MyMode have been completed.
►If required, take the weight off the product and correct the switching.
CAUTION
Improper use of the stance function
Falling due to unexpected product behaviour because of changed damping behaviour.
►Make sure that the patient is standing safely when using the stance function and checks the lock of the knee
joint before placing his/her full weight on the prosthesis.
►Inform the patient whether and in what way the stance function was configured in the adjustment software.
Information on the stance function see Page30.
18
Safety
Genium X3 3B5-2/3B5-2=ST

CAUTION
Quickly pushing the hip forward with the prosthesis extended (e.g. serve while playing tennis)
> Falling due to unexpected activation of the swing phase.
►Note that the knee joint may flex unexpectedly when the hip is pushed forward quickly while the prosthesis is
extended.
►If the patient participates in sports where this movement pattern can occur, configure corresponding
MyModes using the adjustment software. For further information about the MyModes, see the section
'MyModes' (see Page40).
5.9 Notes on the safety modes
CAUTION
Using the product in safety mode
Falling due to unexpected product behaviour because of changed damping behaviour.
►The warnings/error signals (see Page49) have to be observed.
►Particular caution is necessary when using a bicycle without a freewheel (with a fixed gear).
CAUTION
Safety mode cannot be activated due to malfunction caused by water penetration or mechanical damage
Falling due to unexpected product behaviour because of changed damping behaviour.
►Using the product when it is defective is prohibited.
►The product must be inspected by an authorised Ottobock Service Centre.
CAUTION
Safety mode cannot be deactivated
Falling due to unexpected product behaviour because of changed damping behaviour.
►If safety mode cannot be deactivated by recharging the battery, a permanent error has occurred.
►Using the product when it is defective is prohibited.
►The product must be inspected by an authorised Ottobock Service Centre.
CAUTION
Safety signal occurs (ongoing vibration)
Falling due to unexpected product behaviour because of changed damping behaviour.
►The warnings/error signals (see Page49) have to be observed.
►After the safety signal has been emitted, further use of the product is prohibited.
►The product must be inspected by an authorised Ottobock Service Centre.
5.10 Instructions for use with an osseointegrated implant system
WARNING
High mechanical loads due to normal or unusual situations, such as falling
> Overloading of the bone, which can lead to pain, loosening of the implant, necrosis or fracture among other
things.
> Damage or breakage of the implant system or its components (safety components...).
►Verify compliance with the fields of application, conditions of use and indications according to the information
of the manufacturers, both for the knee joint and for the implant system.
►Note the instructions of the clinical personnel that indicated the use of the osseointegrated implant system.
5.11 Information on the use of a mobile device with the cockpit app
CAUTION
Improper use of the device
Falling due to altered damping behaviour as a result of unexpected switching into MyMode.
►Use the instructions for use (user) to instruct the patient on proper use of the device with the cockpit app.
19Genium X3 3B5-2/3B5-2=ST
Safety

CAUTION
Independently applied changes or modifications made to the device
Falling due to altered damping behaviour as a result of unexpected switching into MyMode.
►Do not make any independent changes to the hardware of the device.
►Do not make any independent changes to the software/firmware of the device which are not included in the
update function of the software/firmware.
CAUTION
Improper mode switching with the device
Falling due to unexpected product behaviour because of changed damping behaviour.
►Ensure that the patient stands securely during all switching processes.
►Inform the patient that the changed damping characteristics have to be verified after switching, and feedback
from the acoustic signal emitter and the device display must be observed.
►Switching back to basic mode is mandatory once the activities in MyMode have been completed.
NOTICE
Destruction of the device due to falling or penetration of water
Malfunction of the device.
►If necessary, let the device dry at room temperature (at least 1 day).
►If it should no longer be possible to switch back from a MyMode to basic mode, the component can only be
switched back to basic mode by using a movement pattern (see Page42) or by connecting/disconnecting the
inductive battery charger.
NOTICE
Failure to observe the system requirements for the installation of the cockpit app
Malfunction of the device.
►Install the cockpit app only on the operating systems listed in the section "System requirements" (see
Page27). The tested devices are listed in this section as well.
6 Scope of Delivery and Accessories
Scope of Delivery
• 1pc. 3B5-2=ST Genium X3 (with threaded con
nector) or
1pc. 3B5-2 Genium X3 (with pyramid connector)
with preinstalled 4X900 or 4X193-1 Genium X3 Pro
tective Cover
• 1 pc. 2R19 AXON tube adapter
• 1 pc. 757L16* power supply
• 1pc. 4E60* inductive charger
• 1 pc. 4H101 7.5° X3 flexion stop
• 1 pc. 4H102 15° X3 flexion stop (preassembled on
delivery)
• 2pc. M3x5 Torx screws (as replacement for the
installed screws of the flexion stop)
• 1 pc. T10 Torx bit
• 2pc. M5x16 Torx screws (as replacement for the installed screws of the tube clamp)
• 1pc. cosmetic case for battery charger and power
supply
• 1pc. 646C107 Bluetooth PIN card
• 1 pc. 647F542 prosthesis passport
• 1 pc. card holder for prosthesis passport
• 1pc. 647G1149 instructions for use (qualified per
sonnel)
• 1pc. 646D460, 646D460=1 instructions for use
(user)
• Android app "Cockpit 4X441-Andr=V*" for down
load from the website:
http://www.ottobock.com/cockpitapp
Accessories
The following components are not included in the scope of delivery and may be ordered separately:
• Genium X3 Protective Cover: 4X900
• Genium X3 Protective Cover: 4X193-1
• X3 – flexion stop 22.5°: 4H104
• 4X350-X3 remote control
The user interface is available in the following lan
guages: German, English, French, Italian, Spanish,
Dutch, Swedish
20
Scope of Delivery and Accessories
Genium X3 3B5-2/3B5-2=ST