Otto Bock Kenevo 3C60 User manual

Kenevo 3C60/3C60=ST
Instructions for use (qualified personnel) ................................................................. 5

DE | INFORMATION
Zusätzlich zu der gedruckten Gebrauchsanweisung, sind auch weitere Sprachen auf CD beigelegt (siehe rückseitigen Um
schlag). Auf Anfrage können Sie eine gedruckte Gebrauchsanweisung kostenlos in der jeweiligen Landessprache unter der un
ten angegebenen Anschrift bestellen.
EN | INFORMATION
In addition to the printed Instructions for Use, additional language versions are also included on CD (see back cover). You can
order a printed version of the Instructions for Use at no charge in the respective national language at the address below.
FR | INFORMATION
Le mode d‘emploi est disponible en d‘autres langues sur CD en supplément de la version imprimée (voir au dos de la couver
ture). Vous pouvez commander gratuitement une version imprimée du mode d‘emploi dans la langue de votre choix en envoyant
votre demande à l‘adresse indiquée ci-dessous.
ES | INFORMAĆION
Aparte de las instrucciones de uso impresas, se incluye un CD con dichas instrucciones en otros idiomas (véase la solapa del
dorso). Puede solicitar de forma gratuita unas instrucciones de uso impresas en el idioma de su país a la dirección que se indi
ca más abajo.
IT | INFORMAZIONE
In aggiunta alle istruzioni per l‘uso in formato cartaceo, il CD contiene le istruzioni anche in altre lingue (vedere il retro della co
pertina). Su richiesta, potete ordinare gratuitamente le istruzioni per l‘uso in formato cartaceo nella relativa lingua del vostro
Paese all‘indirizzo di seguito riportato.
PT | INFORMAÇÃO
Adicionalmente ao manual de utilização impresso encontra-se incluído um CD com mais idiomas (consultar a contracapa). A
pedido é possível encomendar gratuitamente um exemplar impresso do manual de utilização no respectivo idioma junto do
endereço especificado.
NL | INFORMATIE
De gebruiksaanwijzing is behalve in gedrukte vorm ook in diverse andere talen bijgevoegd op cd (zie de achterzijde van de oms
lag). Een gedrukte gebruiksaanwijzing in de gewenste taal kunt u kosteloos bestellen op het hieronder vermelde adres.
SE | INFORMATION
Som komplement till den tryckta bruksanvisningen har dessutom ytterligare språk bifogats på CD (se baksidan av omslaget).
Vid efterfrågan kan du utan kostnad beställa en tryckt bruksanvisning i det respektive språket under den angivna adressen.
DA | INFORMATION
Supplerende til brugsanvisningen på papir er der også vedlagt yderligere sprog på cd (se bagsiden af omslaget). På den oplys
te adresse nedenfor kan du bestille en gratis brugsanvisning på papir på det pågældende sprog.
NO | INFORMASJOU
I tillegg til den trykte bruksanvisningen er flere språk vedlagt på CD (se på baksiden omslaget). Ved forespørsel kan du bestille
en gratis trykt bruksanvisning i det gjeldende språket via adressen nedenfor.
FI | TIEDOT
Painetun käyttöohjeen lisäksi tarjoaa oheinen CD-levy käyttöön myös lisää kieliä (katso kansilehden takapuoli). Painettu käyt
töohje kunkin maan omalla kielellä on pyynnöstä tilattavissa maksutta alla ilmoitetusta osoitteesta.
CZ | INFORMACE
Kromě této vytištěné verze návodu k použití jsou na přiloženém CD k dispozici také další jazykové verze překladu (viz zadní stra
na obalu). V případě požadavku si můžete na níže uvedené adrese zdarma objednat vytištěný návod k použití v příslušném jazy
ce.
PL | INFORMACJA
Dodatkowo do wydrukowanej instrukcji użytkowania dołączono na CD wersję w innych językach (patrz tył okładki). Na żądanie
istnieje możliwość zamówienia bezpłatnie pod podanym poniżej adresem wydrukowanej instrukcji użytkowania w języku danego
kraju.
SK | INFORMÁCIA
Dodatočne ku vytlačenému návodu na používanie sú na CD uložené aj ďalšie jazyky (pozri zadnú obálku). Na požiadanie si
môžete bezplatne objednať vytlačený návod na používanie v príslušnom jazyku krajiny na dole uvedenej adrese.
HU | INFORMATION
A kinyomtatott használati utasítást kiegészíti a további nyelveket tartalmazó, mellékelt CD (ld. a hátlapon lévő borítékot). Az
alábbi címen, kérésre költségmentesen megrendelhet az adott ország nyelvén kinyomtatott használati utasítást.
HR | INFORMACIJA
Dodatno uz tiskane upute za uporabu priloženi su i drugi jezici na CD-u (vidi poleđinu). Na upit možete na dolje navedenoj adre
si besplatno naručiti tiskane upute za uporabu na dotičnom jeziku.
2 Kenevo 3C60/3C60=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]
3Kenevo 3C60/3C60=ST

4 Kenevo 3C60/3C60=ST

Foreword1 7..............................................................................................................................................................
Product description2 7............................................................................................................................................
Design2.1 7.................................................................................................................................................
Function2.2 7..............................................................................................................................................
Combination possibilities2.3 8.......................................................................................................................
Combination with an osseointegrated implant system2.3.1 8................................................................................
Application3 9...........................................................................................................................................................
Indications for use3.1 9................................................................................................................................
Conditions of use3.2 9..................................................................................................................................
Indications3.3 9...........................................................................................................................................
Qualification3.4 9.........................................................................................................................................
Safety4 10..................................................................................................................................................................
Explanation of warning symbols4.1 10............................................................................................................
Structure of the safety instructions4.2 10........................................................................................................
General safety instructions4.3 10...................................................................................................................
Information on the Power Supply/Battery Charging4.4 12.................................................................................
Battery charger information4.5 12..................................................................................................................
Information on Alignment/Adjustment4.6 13....................................................................................................
Information on Proximity to Certain Areas4.7 14...............................................................................................
Information on Use4.8 15..............................................................................................................................
Notes on the safety modes4.9 16...................................................................................................................
Instructions for use with an osseointegrated implant system4.10 17.....................................................................
Scope of Delivery and Accessories5 17................................................................................................................
Charging the prosthesis battery6 17......................................................................................................................
Connecting the power supply and battery charger6.1 18..................................................................................
Connect battery charger to the product6.2 18..................................................................................................
Display of the current charge level6.3 19.........................................................................................................
Preparation for use7 19...........................................................................................................................................
Alignment7.1 19...........................................................................................................................................
Shortening the Tube Adapter7.1.1 19................................................................................................................
Installing the Tube Adapter7.1.2 20...................................................................................................................
Bench alignment in alignment apparatus7.1.3 20................................................................................................
Checking the socket after bench alignment7.1.4 21............................................................................................
Static alignment optimisation7.1.5 22................................................................................................................
Dynamic alignment optimisation7.1.6 22............................................................................................................
Flexion stop7.1.7 23........................................................................................................................................
Completing the alignment7.2 23....................................................................................................................
Use8 23......................................................................................................................................................................
Movement pattern in activity mode A (locked mode)8.1 23................................................................................
Standing8.1.1 23............................................................................................................................................
Walking8.1.2 24.............................................................................................................................................
Sitting down8.1.3 24.......................................................................................................................................
Sitting8.1.4 24................................................................................................................................................
Standing up8.1.5 24.......................................................................................................................................
Walking down stairs8.1.6 25............................................................................................................................
Walking up stairs8.1.7 25................................................................................................................................
Walking backwards8.1.8 25.............................................................................................................................
Movement pattern in activity mode B (semi-locked mode) / B+ (semi-locked mode with stance phase flex
ion)
8.2
25...................................................................................................................................................
Standing8.2.1 25............................................................................................................................................
Walking8.2.2 26.............................................................................................................................................
Sitting down8.2.3 26.......................................................................................................................................
Table of contents
5Kenevo 3C60/3C60=ST
Table of contents

Sitting8.2.4 26................................................................................................................................................
Standing up8.2.5 26.......................................................................................................................................
Walking down stairs8.2.6 27............................................................................................................................
Walking up stairs8.2.7 27................................................................................................................................
Walking backwards8.2.8 27.............................................................................................................................
Movement pattern in activity mode C (yielding mode)8.3 28..............................................................................
Standing8.3.1 28............................................................................................................................................
Walking8.3.2 28.............................................................................................................................................
Sitting down8.3.3 28.......................................................................................................................................
Sitting8.3.4 28................................................................................................................................................
Standing up8.3.5 29.......................................................................................................................................
Walking down stairs8.3.6 29............................................................................................................................
Walking up stairs8.3.7 29................................................................................................................................
Walking down a ramp8.3.8 30..........................................................................................................................
Walking backwards8.3.9 30.............................................................................................................................
Using a wheelchair8.4 30..............................................................................................................................
Switching off the product8.5 30.....................................................................................................................
Additional operating states (modes)9 31..............................................................................................................
Empty battery mode9.1 31.............................................................................................................................
Mode for charging the prosthesis9.2 31..........................................................................................................
Safety mode9.3 31.......................................................................................................................................
Overheating mode9.4 31...............................................................................................................................
Cleaning10 31.............................................................................................................................................................
Maintenance11 31......................................................................................................................................................
Identification of the product by the Service Center11.1 32..................................................................................
Legal information12 32..............................................................................................................................................
Liability12.1 32..............................................................................................................................................
Trademarks12.2 32........................................................................................................................................
CE conformity12.3 32.....................................................................................................................................
Local Legal Information12.4 32.......................................................................................................................
Technical data13 34...................................................................................................................................................
Appendices14 36........................................................................................................................................................
Symbols Used14.1 36....................................................................................................................................
Operating states/error signals14.2 37..............................................................................................................
Signals for operating states14.2.1 37..................................................................................................................
Warnings/error signals14.2.2 37........................................................................................................................
Status signals14.2.3 38.....................................................................................................................................
Directives and manufacturer’s declaration14.3 39..............................................................................................
Electromagnetic environment14.3.1 39................................................................................................................
6 Kenevo 3C60/3C60=ST
Table of contents

1 Foreword
INFORMATION
Date of last update: 2018-11-20
►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 "Kenevo 3C60/3C60=ST" is referred to as the product/prosthesis/knee joint below.
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:
8
6
5
4
3
2
1
1. Proximal pyramid adapter
2. LED (blue) as indicator for the Bluetooth connec
tion
3. 8° flexion stops (already installed on delivery)
4. Battery and cover caps
5. Hydraulic unit
6. Receiver of the inductive charging unit
7. Distal tube clamp screw
8. Connecting cable for tube adapter
2.2 Function
This product features a microprocessor-controlled switch between the stance phase and swing phase and a micro
processor-controlled stance 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 phase, the system can be individually adapted to the needs of the
patient.
For this purpose, the product is configured with the "K-Soft" adjustment software.
Through the adjustment software, it is possible to choose from three activity modes that make the various functions
of the product available. This permits optimum adaptation of the product to the corresponding mobility grade of the
patient. The configured activity mode cannot be changed by the patient.
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31).
The microprocessor-controlled hydraulic unit offers the following advantages
• Stability while standing and walking
7Kenevo 3C60/3C60=ST
Foreword

• Smooth, harmonious, quiet initiation of the swing phase
• Automatic recognition of sitting down. Manual unlocking of the joint not required.
• Support while sitting down with individually adaptable resistance. This resistance remains constant during the
entire process of sitting down.
• Support while standing up. The knee joint can be loaded even before reaching full extension.
• Approximation of the physiological gait pattern
• Adaptation of product characteristics to various surfaces, inclines, gait situations and walking speeds
• Manual locking of the knee joint for use of a wheelchair (see Page30). This function makes it possible to lock
the knee joint in any extended position while sitting down. This is particularly useful in order to keep the foot
from dragging on the ground when the patient is being transported in a wheelchair.
2.3 Combination possibilities
This product can be combined with the following Ottobock components:
Adapters
• Double adapter: 4R72=32
• Double adapter: 4R72=45
• Double adapter: 4R72=60
• Double adapter: 4R72=75
• Double adapter: 4R76
• Double adapter: 4R78
• 4R104=60 double adapter, sliding
• 4R104=75 double adapter, sliding
• Rotation adapter: 4R57, 4R57=*
• 4R89 lamination anchor with pyramid adapter
• 4R116 lamination anchor with pyramid adapter
• 4R41 lamination anchor with pyramid receiver
• 4R111 lamination anchor with pyramid receiver
• Lamination anchor with pyramid receiver and
angled arm: 4R119
• 4R43 lamination anchor with threaded connector
• 4R111=N lamination anchor with threaded connect
or
• 4R40 torsion adapter
• 4R118 adapter plate
AXON tube adapter
• AXON tube adapter: 2R17
• AXON tube adapter: 2R20
• AXON tube adapter with torsion unit: 2R21
Cosmetic cover
• Foam cover: 3S26
Prosthetic feet
The maximum allowable patient weight depends on the foot size.
• Cosmetic light foot: 1G6
• Pedilan single axis foot, light: 1G9
• Single axis foot without toes: 1H32 or 1H34
(depending on the heel height)
• Single axis foot with toes: 1H38 or 1H40 (depend
ing on the heel height):
• SACH foot with toes: 1S49, 1S66, or 1S67
(depending on the heel height and foot shape):
• SACH Foot with toes and abducted big toe: 1S90
• SACH+foot: 1S101, 1S102, 1S103
• Terion K2: 1C11
• 1D10 Dynamic foot
• Dynamic foot without adapter: 1D10
• 1D11 Dynamic foot (women)
• 1M10 Adjust
• 1A30 Greissinger plus
• Terion: 1C10
• 1C30 Trias
• 1D35 Dynamic Motion
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34).
8
Product description
Kenevo 3C60/3C60=ST

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 prosthetic fittings.
3.2 Conditions of use
The product was developed for everyday use and should not be used for walking speeds over 3km/h or 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34).
The prosthesis is intended for use exclusively on the patient for whom the adjustment was made. The manufac
turer does not authorise use of the prosthesis on another person.
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.
Activity mode A (locked mode)
°
kg
This product is recommended for mobility grade1 (indoor walker). Approved for a body weight of
max.125kg.
Activity mode B (semi-locked mode)
°
kg
This product is recommended for mobility grade1 (indoor walker) and mobility grade2 (restric
ted outdoor walker). Approved for a body weight of max.125kg.
Activity mode C (yielding mode)
°
kg
This product is recommended for mobility grade2 (restricted outdoor walker). Approved for a
body weight of max.125kg.
3.3 Indications
• For patients with knee disarticulation or transfemoral amputation
• For unilateral or bilateral amputation
• Dysmelia patients with residual limb characteristics corresponding to knee disarticulation or a transfemoral
amputation
• 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.
9Kenevo 3C60/3C60=ST
Application

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37) and corresponding change in damping settings must be observed.
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.
10
Safety
Kenevo 3C60/3C60=ST

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 solid particles, foreign objects and liquids (such as body and/or wound fluids) are not allowed to
penetrate into the product.
►Do not expose the product to splashed water.
►Thick clothing should be worn over the product as a minimum in rainy conditions.
►If water, salt water or body and/or wound fluid has penetrated the product and components, the Protective
Cover (if any) must be removed immediately. Dry the knee joint and components with a lint-free cloth and
allow the components to fully air dry. The prosthesis must be inspected by an authorised Ottobock Service
Centre.
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).
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.
11Kenevo 3C60/3C60=ST
Safety

4.4 Information on the Power Supply/Battery Charging
CAUTION
Charging the prosthesis without taking it off
Falling due to unexpected behaviour of the prosthesis because of changed damping behaviour.
►Inform the patient that wearing the prosthesis is not permitted during the entire charging process.
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.
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34).
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.
12
Safety
Kenevo 3C60/3C60=ST

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8).
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" see Page34).
►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.
►The screws in the clamp bracket 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 breakage of load-bearing components.
►At maximum flexion (reached under full load!), it is essential to maintain a minimum distance of 3 mm (1/8")
between the hydraulic unit and the socket.
►At maximum flexion and insofar as contact with the frame of the knee joint cannot be avoided (in case of volu
minous residual limbs), the socket must lie flat against the frame. Soft cushioning on the socket will assist in
keeping the socket flat.
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.
13Kenevo 3C60/3C60=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
Error during optimisation of damping behaviour
Falling due to unexpected behaviour of the product.
►Note that the patient must stand very securely during this procedure to ensure safety.
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.
14
Safety
Kenevo 3C60/3C60=ST

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34) 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.
CAUTION
Walking down stairs
Falling due to foot being placed incorrectly on stair as a result of changed damping behaviour.
►Inform the patient that the handrail always has to be used when walking down stairs, and that the patient has
to roll over the edge of the step with the middle of the shoe.
►The warnings and error signals have to be observed (see Page37).
►Notify the patient that resistance in the flexion and extension direction can change in case of warnings and
error signals.
►Particular caution is required when carrying children down the stairs.
15Kenevo 3C60/3C60=ST
Safety

CAUTION
Overheating of the hydraulic unit due to uninterrupted, increased activity (e.g. extended walking down
hill)
> Falling due to unexpected behaviour of the product because of switching into overheating mode.
> Burns due to touching overheated components.
►Be sure to pay attention when pulsating vibration signals start. They indicate the risk of overheating.
►As soon as these pulsating vibration signals begin, the activity level has to be reduced so the hydraulic unit
can cool down.
►Full activity may be resumed after the pulsating vibration signals stop.
►If the activity level is not reduced in spite of the pulsating vibration signals, this could lead to the hydraulic ele
ment overheating and, in extreme cases, cause damage to the product. In this case, the product should be
inspected by an authorised Ottobock Service Centre.
CAUTION
Overloading due to unusual activities
> Falling due to unexpected product behaviour as the result of a malfunction.
> Falling due to breakage of load-bearing components.
> Skin irritation due to defects on the hydraulic unit with leakage of liquid.
►The product was developed for everyday use and should not be used for walking speeds over 3km/h or
unusual activities. These unusual activities include, for example, extreme sports (free climbing, parachuting,
paragliding, etc.).
►Careful handling of the product and its components not only increases their service life but, above all, ensures
the patient's personal safety!
►If the product and its components have been subjected to extreme loads (e.g. due to a fall, etc.), then the
product must be inspected for damage immediately. If necessary, forward the product to an authorised
Ottobock Service Centre.
4.9 Notes on the safety modes
CAUTION
Using the product in safety mode
Falling due to unexpected product behaviour because of changed damping behaviour.
►The warnings/error signals (see Page37) have to be observed.
CAUTION
Safety mode cannot be activated due to malfunction caused by water penetration or mechanical damage
Falling due to unexpected product behaviour because of changed damping behaviour.
►Using the product when it is defective is prohibited.
►The product must be inspected by an authorised Ottobock Service Centre.
CAUTION
Safety mode cannot be deactivated
Falling due to unexpected product behaviour because of changed damping behaviour.
►If safety mode cannot be deactivated by recharging the battery, a permanent error has occurred.
►Using the product when it is defective is prohibited.
►The product must be inspected by an authorised Ottobock Service Centre.
CAUTION
Safety signal occurs (ongoing vibration)
Falling due to unexpected product behaviour because of changed damping behaviour.
►The warnings/error signals (see Page37) have to be observed.
►After the safety signal has been emitted, further use of the product is prohibited.
►The product must be inspected by an authorised Ottobock Service Centre.
16
Safety
Kenevo 3C60/3C60=ST

4.10 Instructions for use with an osseointegrated implant system
WARNING
High mechanical loads due to normal or unusual situations, such as falling
> Overloading of the bone, which can lead to pain, loosening of the implant, necrosis or fracture among other
things.
> Damage or breakage of the implant system or its components (safety components...).
►Verify compliance with the fields of application, conditions of use and indications according to the information
of the manufacturers, both for the knee joint and for the implant system.
►Note the instructions of the clinical personnel that indicated the use of the osseointegrated implant system.
5 Scope of Delivery and Accessories
Scope of Delivery
• 1pc. Kenevo 3C60=ST (with threaded connector)
or
• 1pc. Kenevo 3C60 (with pyramid connector)
• 1 pc. AXON 2R17 tube adapter or
• 1pc. 2R20 AXON tube adapter or
1 pc. 2R21 AXON tube adapter with torsion
• 1pc. 757L16-4 power supply
• 1pc. 4E70* inductive charger • 2 pc. 4H107 8° flexion stop (already installed on
delivery)
• 2pc. 4H108 16° flexion stop
• 1pc. 647G1415 instructions for use (qualified personnel)
• 1pc. 646D1321, 646D1321=1 instructions for use (user)
• 1pc. cosmetic case for battery charger and power
supply
• 1 pc. 647F542 prosthesis passport
• 1 pc. card holder for prosthesis passport
Accessories
The following components are not included in the scope of delivery and may be ordered separately:
• 3S26 cosmetic foam cover
• Kenevo Protective Cover 4X840
• "4X445=V K-Soft" adjustment software
6 Charging the prosthesis battery
The following points must be observed when charging the battery:
• Use the 757L16-4 power supply and 4E70* battery charger to charge the battery.
• The full surface of the inductive charger must be in contact with the receiver of the charging unit. This must be
verified, particularly when fabricating a cosmetic foam cover. Prior to application, check the contact surfaces
for dirt and ensure that no objects are adhering to them.
• The capacity of a fully charged battery is sufficient for one full day.
• We recommend charging the product once a day when used by the patient on a daily basis.
• For the maximum operating time with one battery charge, disconnecting the battery charger from the product
only immediately before using the product is recommended.
• The battery should be charged for at least 3 hours prior to initial use.
• Note the permissible temperature range for charging the battery (see Page34).
• The battery may discharge while the product is not being used.
• The tube adapter must be connected before disconnecting the battery charger, otherwise an error message
will result (see Page37).
17Kenevo 3C60/3C60=ST
Scope of Delivery and Accessories

6.1 Connecting the power supply and battery charger
1 2 3
1) Slide the country-specific plug adapter onto the power supply until it locks into place (see fig.1).
2) Connect the round, three-pin plug of the power supply to the receptacle on the inductive charger so that the
plug locks into place. (see fig.2)
INFORMATION: Ensure correct polarity (guide lug). Do not use force when connecting the cable plug
to the battery charger.
3) Plug the power supply unit into the outlet (see fig.3).
→The green LED on the back of the power supply lights up.
→The yellow LED on the inductive charger lights up briefly to indicate the correct connection to the power
supply.
→If the green LED on the power supply does not light up and the yellow LED on the inductive charger does not
light up briefly while connecting the cable, there is an error (see Page37).
6.2 Connect battery charger to the product
INFORMATION
Do not move the knee joint while it conducts the self-test immediately after disconnecting the charger. Otherwise,
an error may occur; if this happens, the problem can be corrected by reconnecting and then disconnecting the
charger.
1) Remove the prosthesis.
2) Connect the inductive charger to the receiver of the charging unit on the back of
the product.
Make sure the contact surfaces are clean, with no objects adhering to them.
→The charger is held in place by a magnet.
→A correct connection between the battery charger and the product is indic
ated by feedback (see Page38).
3) The charging process starts.
→Once the product battery is fully charged, the LED on the battery charger
lights up green.
4) After the charging process is complete, remove the inductive charger from the
receiver and hold the product still.
→A self-test is performed, and the product should not be moved while this is in
progress. The joint is ready for operation only after corresponding feedback
(see Page38).
5) Put the prosthesis on.
INFORMATION
To make the operating time of the prosthesis as long as possible, the charger should not be removed until imme
diately before the prosthesis is used.
18
Charging the prosthesis battery
Kenevo 3C60/3C60=ST

Indication of the charging process:
Charger
Battery is charging.
The on time of the LED indicates the current battery charge level.
The on time of the LED gets longer as the charge level increases. It only flashes briefly at the start
of the charging process and stays on continuously at the end of the charging process.
Battery is fully charged, or the temperature fell above/below the permissible range during charging.
Check current charge level (see Page19).
6.3 Display of the current charge level
1) Turn the prosthesis 180° (the sole of the foot has to face up).
2) Hold still for 2 seconds and wait for beeps.
Beep signal Vibration signal Battery charge level
5x short more than 80%
4x short 66% to 80%
3x short 51% to 65%
2x short 36% to 50%
1x short 3x long 20% to 35%
1x short 5x long less than 20%
7 Preparation for use
7.1 Alignment
The following alignment guidelines contain descriptions for connecting the knee joint to a prosthetic socket. In
principle, the alignment of the prosthesis is independent of the type of connection for the knee joint. In case of a
connection to an osseointegrated, percutaneous implant system, a socket is not used during bench alignment in
the alignment apparatus. In this case, the central proximal point on the prosthetic socket corresponds to the
trochanter of the thigh bone (see illustration in the section "Bench alignment in the alignment apparatus" see
Page20).
Ensure that possible flexion or adduction of the transfemoral residual limb can be compensated to a permissible
extent by an adapter approved by the implant manufacturer in the course of static alignment optimisation. Safe
functioning of the knee joint is only guaranteed with biomechanically correct alignment.
7.1.1 Shortening the Tube Adapter
CAUTION
Incorrect processing of tube
Falling due to damage to the tube.
►Do not clamp the tube into a vice.
►For shortening the tube, use only a tube cutter.
CAUTION
Damage to the cable while shortening the tube adapter
Falling due to unexpected product behaviour as the result of switching into safety mode.
►When shortening the tube adapter, make sure the cable does not get damaged.
19Kenevo 3C60/3C60=ST
Preparation for use

1) Determine the required length of the tube adapter using the configuration assistant in the adjustment software.
2) Shorten the tube adapter to the determined value with the 719R3 tube cutter.
3) Store the tube adapter cable in the tube adapter. If this is not possible, the cable must be protected against
damage.
4) Use a file (cut 2 (medium), e.g. 715H1=2 recommended) to file the cut edge smooth. Be careful of the tube
adapter cable.
NOTICE! When filing or deburring, make sure that no metal shavings can get into the plug of the tube
adapter cable.
5) Chamfer the outside with a file.
6) Smooth the inside and outside of the cut edge with sandpaper (recommended grit 120).
7.1.2 Installing the Tube Adapter
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" see Page34).
►Observe the instructions for securing the screw connections and the use of the correct length.
1) Install the prosthetic foot on the tube adapter and tighten the set screws on the tube adapterto a torque of
15Nm.
INFORMATION: Replace any set screws that are protruding or recessed too much with suitable ones.
For approved set screws, see the section "Technical data" (see Page34).
INFORMATION: The printed scale on the tube adapter must face forward.
2) Connect the cable of the tube adapter to the cable of the knee joint.
3) Push the protruding cable loop back into the tube adapter. If the tube adapter has been shortened to the min
imum length, the plug must be inserted in the cavity. The cable loop must then be stored carefully.
4) Insert the tube adapter about 60mm into the knee joint (for the exact value, consult the configuration assistant
in the adjustment software).
INFORMATION: Corrections in the insertion depth between 40mm and 73mm are permissible (slide
in 13mm and pull out 20mm).
5) Turn the foot outwards slightly and slightly tighten the distal tube clamp screw(approx. 4Nm).
INFORMATION: After alignment optimisation, this screw must be tightened to a torque of 7Nm.
INFORMATION
A calibration procedure must be performed after each change to the tube adapter, prosthetic foot or knee joint
using the adjustment software.
INFORMATION
If the tube adapter is disconnected while the knee joint is operational, an error message is output. To prevent this
error message, the knee joint must be switched off before the tube adapter is disconnected (see Page30).
7.1.3 Bench alignment in alignment apparatus
INFORMATION
The alignment recommendations must be observed in order for the prosthesis to function correctly.
INFORMATION
The patient's gait pattern shall change as he/she becomes accustomed to the prosthesis.
Therefore it is recommended to complete the entire adjustment procedure again about two weeks after the initial
fitting.
A correct bench alignment (e.g. using the 743A200 PROS.A. Assembly alignment apparatus) ensures that the user
can benefit from all the advantages of the product. If the L.A.S.A.R. Assembly alignment apparatus (743L200) is
available, it can be used as well. The position of the residual limb must be taken into account when positioning the
socket connector. Plumb lines in the frontal and sagittal planes (drawn from the hip joint's centre of rotation and
marked during plaster cast taking and trial fitting of the check socket) will facilitate correct positioning of the lamin
ation anchor or socket adapter.
20
Preparation for use
Kenevo 3C60/3C60=ST