Otto Bock 3B1-3 User manual

Genium 3B1-3/3B1-3=ST
Instructions for use (qualified personnel) ................................................................. 9

Quick Reference GuideThis "Quick Reference Guide" does not replace the instructions for use
612345
2 Genium 3B1-3/3B1-3=ST

1234719R3715H1=27.1.2
7Nm710D415Nm710D4max70 mmbasic60 mmmin40 mm123456787.1.3
3Genium 3B1-3/3B1-3=ST

min3 mmmin 5 mm7.1.8
5 sec1237.1.1.3
ConnectionJob SpecificationAlignmentBasic Mode7.1.6
4 Genium 3B1-3/3B1-3=ST

ConnectionJob SpecificationAlignmentBasic ModePatient dataAlignment recommendationStaticPatient dataAlignment recommendationStaticPatient dataAlignment recommendationStatic
2
1
1
4
5
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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
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5Genium 3B1-3/3B1-3=ST



Magnetic components
x-Nm
Use a torque wrench
Wrong

Duration
Cockpit App
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 3B1-3/3B1-3=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 3B1-3/3B1-3=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 3B1-3/3B1-3=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.........................................................................................................................................
Contraindications3.4 14................................................................................................................................
Absolute Contraindications3.4.1 14..................................................................................................................
Relative Contraindications3.4.2 14....................................................................................................................
Qualification3.5 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 17..................................................................................................................
Information on Alignment/Adjustment4.6 18....................................................................................................
Information on Proximity to Certain Areas4.7 20...............................................................................................
Information on Use4.8 20..............................................................................................................................
Notes on the safety modes4.9 22...................................................................................................................
Instructions for use with an osseointegrated implant system4.10 22.....................................................................
Information on the use of a mobile device with the cockpit app4.11 22.................................................................
Scope of Delivery and Accessories5 23................................................................................................................
Scope of delivery5.1 23................................................................................................................................
Accessories5.2 23.......................................................................................................................................
Charging the battery6 24.........................................................................................................................................
Connecting the power supply and battery charger6.1 24..................................................................................
Charging the prosthesis battery6.2 24............................................................................................................
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 25........................................................................
Display of the current charge level during the charging process6.3.3 25................................................................
Preparing the product for use7 26.........................................................................................................................
Alignment7.1 26...........................................................................................................................................
Settings with the "X-Soft" adjustment software7.1.1 26.......................................................................................
Introduction7.1.1.1 26........................................................................................................................................
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....................................................................
Shortening the Tube Adapter7.1.2 27................................................................................................................
Installing the Tube Adapter7.1.3 27...................................................................................................................
Adjusting the torsion moment on the 2R21 AXON tube adapter7.1.4 28.................................................................
Bench alignment in alignment apparatus7.1.5 28................................................................................................
Static alignment optimisation7.1.6 28................................................................................................................
Dynamic alignment optimisation7.1.7 29............................................................................................................
Checking the socket after bench alignment7.1.8 29............................................................................................
Flexion stop7.1.9 29........................................................................................................................................
Optional: Installing the foam cover7.2 30........................................................................................................
Cockpit app8 31........................................................................................................................................................
System Requirements8.1 31..........................................................................................................................
Table of contents
9Genium 3B1-3/3B1-3=ST
Table of contents

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 33...............................................................................................................
Managing components8.4 33........................................................................................................................
Adding component8.4.1 33..............................................................................................................................
Deleting a component8.4.2 34..........................................................................................................................
Connecting component with multiple mobile devices8.4.3 34...............................................................................
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 36................................................................................................................................................
Sitting function9.1.5.1 36...................................................................................................................................
Standing up9.1.6 36.......................................................................................................................................
Walking up stairs step-over-step9.1.7 36...........................................................................................................
Overcoming obstacles9.1.8 37.........................................................................................................................
Walking down stairs9.1.9 38............................................................................................................................
Walking down a ramp9.1.10 38..........................................................................................................................
Configuration for walking down stairs/ramp using the adjustment software9.1.11 38................................................
Changing prosthesis settings9.2 38...............................................................................................................
Changing the prosthesis setting using the cockpit app9.2.1 39............................................................................
Overview of adjustment parameters in basic mode9.2.1.1 39..................................................................................
Overview of adjustment parameters in MyModes9.2.1.2 40.....................................................................................
Turning Bluetooth on the prosthesis on/off9.3 41.............................................................................................
Switching Bluetooth off/on using the cockpit app9.3.1 41....................................................................................
Querying the prosthesis status9.4 41..............................................................................................................
Query status through cockpit app9.4.1 41.........................................................................................................
Status display in the cockpit app9.4.2 41...........................................................................................................
Mute mode (silent mode)9.5 41.....................................................................................................................
Turning mute mode on/off using the Cockpit app9.5.1 41....................................................................................
Deep sleep mode9.6 42................................................................................................................................
Turning deep sleep mode on/off using the Cockpit app9.6.1 42...........................................................................
OPG function (Optimised Physiological Gait)9.7 42.........................................................................................
MyModes10 43............................................................................................................................................................
Switching MyModes with the cockpit app10.1 43..............................................................................................
Switching MyModes using motion patterns10.2 44............................................................................................
Switching from a MyMode back to basic mode10.3 45.......................................................................................
Additional operating states (modes)11 45..............................................................................................................
Empty battery mode11.1 45.............................................................................................................................
Mode for charging the prosthesis11.2 45..........................................................................................................
Safety mode11.3 46.......................................................................................................................................
Overheating mode11.4 46...............................................................................................................................
Storage and bleeding12 46.......................................................................................................................................
Cleaning13 46.............................................................................................................................................................
Maintenance14 47......................................................................................................................................................
Identification of the product by the Service Center14.1 47..................................................................................
Legal information15 47..............................................................................................................................................
Liability15.1 47..............................................................................................................................................
Trademarks15.2 47........................................................................................................................................
CE conformity15.3 47.....................................................................................................................................
Local Legal Information15.4 48.......................................................................................................................
Technical data16 49...................................................................................................................................................
10 Genium 3B1-3/3B1-3=ST
Table of contents

Appendices17 51........................................................................................................................................................
Symbols Used17.1 51....................................................................................................................................
Operating states/error signals17.2 52..............................................................................................................
Signals for operating states17.2.1 53..................................................................................................................
Warnings/error signals17.2.2 53........................................................................................................................
Error messages while establishing a connection with the cockpit app17.2.3 55........................................................
Status signals17.2.4 55.....................................................................................................................................
Directives and manufacturer’s declaration17.3 56..............................................................................................
Electromagnetic environment17.3.1 56................................................................................................................
11Genium 3B1-3/3B1-3=ST
Table of contents

1 Foreword
INFORMATION
Date of last update: 2020-05-28
►Please read this document carefully before using the product and observe the safety notices.
►Instruct the user in the safe use of the product.
►Please contact the manufacturer if you have questions about the product or in case of problems.
►Report each serious incident in connection with the product, in particular a worsening of the state of health, to
the manufacturer and to the relevant authority in your country.
►Please keep this document for your records.
The product “3B1-3, 3B1-3=ST 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.
According to the manufacturer (Otto Bock Healthcare Products GmbH), the patient is the operator of the product
according to the IEC 60601-1:2005/A1:2012 standard.
2 Product description
2.1 Design
The product consists of the following components:

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
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.
The product can be individually adapted to the needs of the patient 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43).
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46).
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 3B1-3/3B1-3=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
Essential performance of the product
• Stability in the stance phase
• Adjustable swing phase extension resistance
2.3 Combination possibilities
This product can be combined with the following Ottobock components:
Prosthetic hip joints
• Modular prosthetic hip joint: 7E7
• Monocentric prosthetic hip joint: 7E9
• Helix 3D prosthetic hip joint: 7E10
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: 2R20
• AXON tube adapter with torsion unit: 2R21
Cosmetic cover/protector
• Foam cover: 3S26
• 4X880=* Genium Protective Cover
Prosthetic feet
The maximum allowable patient weight depends on the foot size.
• 1M10 Adjust
• 1A30 Greissinger plus
• 1C30 Trias
• 1D35 Dynamic Motion
• 1C40 C-Walk
• Taleo: 1C50
• 1C60 Triton
• 1C61 Triton Vertical Shock
• 1C62 Triton Harmony
• 1C63 Triton Low Profile
• 1C64 Triton Heavy Duty
• Triton side flex: 1C68
• 1E56 Axtion
• 1E57 Lo Rider
• Challenger: 1E95
• 1B1 Meridium
• Meridium: 1B1-2
• 1C10 Terion
• Empower: 1A1-1
The 1C63 Triton Low Profile prosthetic foot may only be combined with this knee joint in the ranges listed below
(see table).
Please contact Ottobock customer service if you would like a combination outside the approved ranges.
Body weight Approved foot size [cm]
Up to 125kg (up to 275lbs) 21 to 30
126kg to 150kg (276lbs to 330lbs) 21 to 28
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
13Genium 3B1-3/3B1-3=ST
Product description

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49).
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.
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49).
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.
Knee joint with attached 2R20 AXON tube adapter
°
kg
The product is recommended for mobility grade2 (restricted outdoor walker), 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 150kg (330 lbs).
Knee joint with attached 2R21 AXON tube adapter with torsion
°
kg
The product is recommended for mobility grade2 (restricted outdoor walker), 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 or hip disarticulation
• 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 Contraindications
3.4.1 Absolute Contraindications
• Body weight over 150kg
3.4.2 Relative Contraindications
None.
3.5 Qualification
The product may be fitted only by qualified personnel authorised by Ottobock after completing the corresponding
training.
If the product is to be connected to an osseointegrated implant system, the qualified personnel must also be
authorised for the connection to the osseointegrated implant system.
14
Application
Genium 3B1-3/3B1-3=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
WARNING
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 the event of failure to observe the hazard
> E.g.: Consequence 2 in the event 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53) 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 3B1-3/3B1-3=ST
Safety

CAUTION
Independent manipulation of the product and the 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 authorised, qualified Ottobock 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 is weather-proof but not resistant to corrosion. Therefore, the knee joint should not come into
contact with salt water, chlorinated water or other solutions (such as soap or shower gel, and body and/or
wound fluids). Do not use the knee joint under extreme conditions like diving or jumping into water. The knee
joint is not designed for prolonged underwater use or prolonged submersion.
►After contact with water, remove the Protective Cover (if installed) and hold the prosthesis with the sole of the
foot facing up until the water has drained from the knee joint and tube adapter. Dry the knee joint and com
ponents with a lint-free cloth and allow the components to fully air dry.
►Should the knee joint or tube adapter come into contact with salt water, chlorinated water or other solu
tions (such as soap or shower gel, and body and/or wound fluids), promptly remove the Protective Cover (if
installed) and clean the knee joint. In order to do so, rinse knee joint, tube adapter and Protective Cover with
fresh water and let them dry.
►In case of a malfunction after drying, the knee joint and tube adapter must be inspected by an authorised
Ottobock Service Center.
►The knee joint is not resistant to penetration from water jets or steam.
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.
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CAUTION
Signs of wear and tear on the product components
Falling due to damage or malfunction of the product.
►Regular service inspections (maintenance) are mandatory in the interest of patient safety and in order to main
tain operating reliability and protect the warranty.
CAUTION
Use of unapproved accessories
> Falling due to product malfunction as a result of reduced interference resistance.
> Interference of other electronic devices due to increased emissions.
►Use the product only in combination with the accessories, signal converters and cables listed in the sections
"Scope of delivery" (see Page23) and "Accessories" (see Page23).
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).
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.
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
WARNING
Storing/transporting the product near active implanted systems
Interference with active implantable systems (e.g., pacemaker, defibrillator, etc.) due to electromagnetic interfer
ence of the product.
►When storing/transporting the product in the immediate vicinity of active implantable systems, ensure that the
minimum distances stipulated by the manufacturer of the implant are observed.
►Make sure to observe any operating conditions and safety instructions stipulated by the manufacturer of the
implant.
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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49).
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 prosthesis 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).
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.
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49).
►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.
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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 when using the adjustment software to adjust settings
Fall due to unexpected prosthesis behaviour.
►Do not charge the prosthesis battery during the adjustment process since the prosthesis is not functional
while the battery is being charged.
►During the adjustment process, the prosthesis must not remain unattended while connected to the software if
it is being worn by the patient.
►Observe the maximum range of the Bluetooth connection and note that obstacles may limit this range.
►During the data transfer (PC to prosthesis), the prosthesis wearer should sit or stand still, and the BionicLink
PC must not be removed from the computer.
►If you only want to make temporary changes to the settings while connected to the adjustment software, you
must reverse these changes before disconnecting the adjustment software.
You must also ensure the patient does not leave the range of the Bluetooth connection if settings have been
changed temporarily.
►Inform the patient immediately if the data connection is accidentally interrupted during the adjustment pro
cess.
►The connection to the prosthesis must always be disconnected after adjustments have been completed.
►Successful participation on an Ottobock product training course is mandatory prior to initial use. Additional
product training courses may be required to qualify for software updates.
►It is very important to enter the correct foot size, prosthesis dimensions and body weight in order to achieve a
quality 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, you will need
to readjust the settings when the patient no longer requires the respective aids.
►Use the online help function which is integrated into the software.
►Do not disclose 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.
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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
Operating the product in very close proximity to other electronic devices
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
►Do not operate the product in the immediate vicinity of other electronic devices.
►Do not stack the product with other electronic devices during operation.
►If simultaneous operation cannot be avoided, monitor the product and verify proper use in the existing setup.
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).
►In general, monitor the product for unexpected changes in the damping behaviour when electronic or magnet
ic devices are in the immediate vicinity.
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49) during trial fit
ting.
4.8 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.
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