Otto Bock Genium X3 3B5-3 User manual

Genium X3 3B5-3/3B5-3=ST
Instructions for use (qualified personnel) ................................................................. 9

Quick Reference GuideThis "Quick Reference Guide" does not replace the instructions for use
612345
1237.1.2
2 Genium X3 3B5-3/3B5-3=ST

1234719R3715H1=27.1.3
7Nm710D415Nm710D4max70 mmbasic60 mmmin40 mm123456787.1.4
3Genium X3 3B5-3/3B5-3=ST

1237.1.8
min3 mmmin 5 mm7.1.9
ConnectionJob SpecificationAlignmentBasic Mode7.1.6
4 Genium X3 3B5-3/3B5-3=ST

ConnectionJob SpecificationAlignmentBasic ModePatient dataAlignment recommendationStaticPatient dataAlignment recommendationStaticPatient dataAlignment recommendationStatic
2
1
1
4
5
2
-
+
3
0
7.1.6321
ConnectionJob SpecificationAlignmentBasic ModeStance phaseSwing phaseFunctions in the gait cycleAdditional functionsStance phaseSwing phaseFunctions in the gait cycleAdditional functionsStance phaseSwing phaseFunctions in the gait cycleAdditional functionsStance phaseSwing phaseFunctions in the gait cycleAdditional functions
120 130 140
150
160 170 180
150
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55 62 68 7060
7.1.71234
min3 mmmin 5 mm7.1.9
5Genium X3 3B5-3/3B5-3=ST

Symbols Used
Read the section in the instructions for use
Magnetic components
Tightening torque in the direction of rotation and screw geometryx-Nm
Use a torque wrench
Wrong
Right
Use the adjustment software
A successful connection between the product and the adjustment software is established
Fill in the fields in the adjustment software
Check the values
6 Genium X3 3B5-3/3B5-3=ST

DE | INFORMATION
Zusätzlich zu der gedruckten Gebrauchsanweisung, sind auch weitere Sprachen auf CD beigelegt (siehe rückseitigen Umsch
lag). Auf Anfrage können Sie eine gedruckte Gebrauchsanweisung kostenlos in der jeweiligen Landessprache unter der unten
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
indica 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
copertina). 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
omslag). 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
oplyste 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
käyttöohje 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
strana obalu). V případě požadavku si můžete na níže uvedené adrese zdarma objednat vytištěný návod k použití v příslušném
jazyce.
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
adresi besplatno naručiti tiskane upute za uporabu na dotičnom jeziku.
7Genium X3 3B5-3/3B5-3=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]
8 Genium X3 3B5-3/3B5-3=ST

Foreword1 12............................................................................................................................................................
Product description2 12..........................................................................................................................................
Design2.1 12...............................................................................................................................................
Function2.2 12............................................................................................................................................
Combination possibilities2.3 13.....................................................................................................................
Combination with an osseointegrated implant system2.3.1 13..............................................................................
Application3 14.........................................................................................................................................................
Indications for use3.1 14...............................................................................................................................
Conditions of use3.2 14................................................................................................................................
Indications3.3 14.........................................................................................................................................
Qualification3.4 14.......................................................................................................................................
Safety4 15..................................................................................................................................................................
Explanation of warning symbols4.1 15............................................................................................................
Structure of the safety instructions4.2 15........................................................................................................
General safety instructions4.3 15...................................................................................................................
Information on the Power Supply/Battery Charging4.4 17.................................................................................
Battery charger information4.5 18..................................................................................................................
Information on Alignment/Adjustment4.6 18....................................................................................................
Information on Proximity to Certain Areas4.7 20...............................................................................................
Information on Use4.8 21..............................................................................................................................
Notes on the safety modes4.9 22...................................................................................................................
Instructions for use with an osseointegrated implant system4.10 23.....................................................................
Information on the use of a mobile device with the cockpit app4.11 23.................................................................
Scope of Delivery and Accessories5 24................................................................................................................
Charging the battery6 24.........................................................................................................................................
Connecting the power supply and battery charger6.1 25..................................................................................
Charging the prosthesis battery6.2 25............................................................................................................
Display of the current charge level6.3 25.........................................................................................................
Display of battery charge level without additional devices6.3.1 25.........................................................................
Display of the current charge level using the Cockpit app6.3.2 26........................................................................
Display of the current charge level during the charging process6.3.3 26................................................................
Preparation for use7 26...........................................................................................................................................
Alignment7.1 26...........................................................................................................................................
Settings with the "X-Soft" adjustment software7.1.1 27.......................................................................................
Introduction7.1.1.1 27........................................................................................................................................
Data transfer between the product and the PC7.1.1.2 27.......................................................................................
Preparing the product to connect to the adjustment software7.1.1.3 27....................................................................
Removing the Protective Cover7.1.2 27.............................................................................................................
Shortening the Tube Adapter7.1.3 27................................................................................................................
Installing the Tube Adapter7.1.4 28...................................................................................................................
Bench alignment in alignment apparatus7.1.5 28................................................................................................
Static alignment optimisation7.1.6 29................................................................................................................
Dynamic alignment optimisation7.1.7 29............................................................................................................
Protective Cover Installation7.1.8 29.................................................................................................................
Checking the socket after bench alignment7.1.9 29............................................................................................
Flexion stop7.1.10 30........................................................................................................................................
Cockpit app8 30........................................................................................................................................................
System Requirements8.1 31..........................................................................................................................
Initial connection between cockpit app and prosthesis8.2 31.............................................................................
Starting the cockpit app for the first time8.2.1 31................................................................................................
Control elements for cockpit app8.3 32..........................................................................................................
Cockpit app navigation menu8.3.1 32...............................................................................................................
Table of contents
9Genium X3 3B5-3/3B5-3=ST
Table of contents

Managing components8.4 33........................................................................................................................
Adding component8.4.1 33..............................................................................................................................
Deleting a component8.4.2 33..........................................................................................................................
Connecting component with multiple devices8.4.3 33.........................................................................................
Use9 34......................................................................................................................................................................
Movement patterns in basic mode (mode 1)9.1 34...........................................................................................
Standing9.1.1 34............................................................................................................................................
Stance function9.1.1.1 34...................................................................................................................................
Walking9.1.2 35.............................................................................................................................................
Running short distances ("walk-to-run" function)9.1.3 35.....................................................................................
Sitting down9.1.4 35.......................................................................................................................................
Sitting9.1.5 35................................................................................................................................................
Sitting function9.1.5.1 35...................................................................................................................................
Standing up9.1.6 36.......................................................................................................................................
Walking up stairs step-over-step9.1.7 36...........................................................................................................
Overcoming obstacles9.1.8 36.........................................................................................................................
Walking down stairs9.1.9 37............................................................................................................................
Walking down a ramp9.1.10 37..........................................................................................................................
Configuration for walking down stairs/ramp using the adjustment software9.1.11 37................................................
Changing prosthesis settings9.2 37...............................................................................................................
Changing the prosthesis setting using the cockpit app9.2.1 38............................................................................
Overview of adjustment parameters in basic mode9.2.2 38..................................................................................
Overview of adjustment parameters in MyModes9.2.3 39.....................................................................................
Turning Bluetooth on the prosthesis on/off9.3 40.............................................................................................
Switching Bluetooth off/on using the cockpit app9.3.1 40....................................................................................
Querying the prosthesis status9.4 40..............................................................................................................
Query status through cockpit app9.4.1 40.........................................................................................................
Status display in the cockpit app9.4.2 40...........................................................................................................
Mute mode (silent mode)9.5 41.....................................................................................................................
Turning mute mode on/off using the Cockpit app9.5.1 41....................................................................................
Deep sleep mode9.6 41................................................................................................................................
Turning deep sleep mode on/off using the Cockpit app9.6.1 41...........................................................................
OPG function (Optimised Physiological Gait)9.7 41.........................................................................................
MyModes10 42............................................................................................................................................................
Running function as configured MyMode10.1 42...............................................................................................
Switching MyModes with the cockpit app10.2 43..............................................................................................
Switching MyModes using motion patterns10.3 43............................................................................................
Switching from a MyMode back to basic mode10.4 44.......................................................................................
Additional operating states (modes)11 45..............................................................................................................
Empty battery mode11.1 45.............................................................................................................................
Mode for charging the prosthesis11.2 45..........................................................................................................
Safety mode11.3 45.......................................................................................................................................
Overheating mode11.4 45...............................................................................................................................
Storage and bleeding12 46.......................................................................................................................................
Cleaning13 46.............................................................................................................................................................
Maintenance14 46......................................................................................................................................................
Identification of the product by the Service Center14.1 46..................................................................................
Legal information15 47..............................................................................................................................................
Liability15.1 47..............................................................................................................................................
Trademarks15.2 47........................................................................................................................................
CE conformity15.3 47.....................................................................................................................................
Local Legal Information15.4 47.......................................................................................................................
Technical data16 48...................................................................................................................................................
10 Genium X3 3B5-3/3B5-3=ST
Table of contents

Appendices17 50........................................................................................................................................................
Symbols Used17.1 50....................................................................................................................................
Operating states/error signals17.2 51..............................................................................................................
Signals for operating states17.2.1 51..................................................................................................................
Warnings/error signals17.2.2 52........................................................................................................................
Error messages while establishing a connection with the cockpit app17.2.3 54........................................................
Status signals17.2.4 54.....................................................................................................................................
Directives and manufacturer’s declaration17.3 55..............................................................................................
Electromagnetic environment17.3.1 55................................................................................................................
11Genium X3 3B5-3/3B5-3=ST
Table of contents

1 Foreword
INFORMATION
Date of last update: 2018-03-23
►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.
2 Product description
2.1 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
2.2 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 product 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.cycling ...). These are pre-configured using the
adjustment software and can be activated with special movement patterns and the Cockpit app (see Page42).
In case of a product malfunction, safety mode makes restricted operation possible. Resistance parameters that are
predefined by the product are configured for this purpose (see Page45).
Empty battery mode permits safe walking when the battery is drained. Resistance parameters that are predefined
by the product are configured for this purpose (see Page45).
12 Genium X3 3B5-3/3B5-3=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
2.3 Combination possibilities
This product can be combined with the following Ottobock components:
Adapters
• 4R104=60 double adapter, sliding
• 4R104=75 double adapter, sliding
• Rotation adapter: 4R57, 4R57=*
• 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
• Quickchange: 4R10
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
• Meridium: 1B1-2
• 1C66 Triton smart ankle
• 1C10 Terion
• Empower: 1A1-1
Depending on the patient's weight, this knee joint may be combined with the 1A1-1 Empower prosthetic foot
in the following foot sizes only (see following table).
Please contact Ottobock customer service if you would like a combination outside the approved ranges.
Body weight Approved foot size [cm]
up to 116 kg (256lbs) 25 to 30
117kg to 125kg (257lbs to 275lbs) 25 to 27
2.3.1 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48).
Please ensure that the qualified personnel applying the product is not only authorised for fitting this knee joint, but
also for the connection to the osseointegrated implant system.
13Genium X3 3B5-3/3B5-3=ST
Product description

3 Application
3.1 Indications for use
The product is to be used solely for lower limb exoprosthetic fittings.
3.2 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48).
The product is intended exclusively for use on one patient. Use of the product by another person is not approved
by the manufacturer.
Our components perform optimally when paired with appropriate components based upon weight and mobility
grades identifiable by our MOBIS classification information and which have appropriate modular connectors.
°
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).
3.3 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.
3.4 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.
14
Application
Genium X3 3B5-3/3B5-3=ST

4 Safety
4.1 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.
4.2 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.
4.3 General safety instructions
WARNING
Non-observance of safety notices
Personal injury/damage to the product due to using the product in certain situations.
►Observe the safety notices and the stated precautions 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52) 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41).
►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.
15Genium X3 3B5-3/3B5-3=ST
Safety

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 the AXON tube adapter are waterproof, corrosion-resistant and protected against the pen
etration of jets of water. 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48).
►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 steam.
16
Safety
Genium X3 3B5-3/3B5-3=ST

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 the product 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 must 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.
4.4 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.
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Safety

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).
4.5 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48).
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.
4.6 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13).
►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 tightening torque values for installation (see the section "Technical data").
►Observe the instructions for securing the screw connections and the use of the correct length.
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Safety
Genium X3 3B5-3/3B5-3=ST

CAUTION
Incorrectly secured screws
Falling due to breakage of load-bearing components caused by screw connections coming loose.
►After completing all settings, the set screws in the tube adapter must be secured before they are tightened to
the specified torque (see the section "Technical data" see Page48).
►The tube clamp screws must not be secured but only tightened to the specified torque.
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.
19Genium X3 3B5-3/3B5-3=ST
Safety

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.
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.
4.7 Information on Proximity to Certain Areas
CAUTION
Insufficient distance to HF communication devices (e.g. mobile phones, Bluetooth devices, WiFi
devices)
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
►Therefore, keeping a minimum distance of 30cm to HF communication devices is recommended.
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).
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Safety
Genium X3 3B5-3/3B5-3=ST