Otto Bock C-Leg 3C98-3 User manual

C-Leg 3C98-3/3C88-3
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 C-Leg 3C98-3/3C88-3

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]
3C-Leg 3C98-3/3C88-3

4 C-Leg 3C98-3/3C88-3

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.....................................................................
Information on the use of a mobile device with the cockpit app4.11 17.................................................................
Scope of Delivery and Accessories5 18................................................................................................................
Charging the battery6 18.........................................................................................................................................
Connecting the power supply and battery charger6.1 19..................................................................................
Charging the prosthesis battery6.2 19............................................................................................................
Display of the current charge level6.3 19.........................................................................................................
Display of battery charge level without additional devices6.3.1 20.........................................................................
Display of the current charge level using the Cockpit app6.3.2 20........................................................................
Preparation for use7 20...........................................................................................................................................
Alignment7.1 20...........................................................................................................................................
Shortening the Tube Adapter7.1.1 20................................................................................................................
Installing the Tube Adapter7.1.2 21...................................................................................................................
Bench alignment in alignment apparatus7.1.3 21................................................................................................
Installing/removing the knee extender7.1.4 22....................................................................................................
Checking the socket after bench alignment7.1.5 23............................................................................................
Static alignment optimisation7.1.6 23................................................................................................................
Dynamic alignment optimisation7.1.7 24............................................................................................................
Flexion stop7.1.8 24........................................................................................................................................
Optional: Installing the foam cover7.2 25........................................................................................................
Cockpit app8 25........................................................................................................................................................
System Requirements8.1 25..........................................................................................................................
Initial connection between cockpit app and prosthesis8.2 25.............................................................................
Starting the cockpit app for the first time8.2.1 26................................................................................................
Control elements for cockpit app8.3 26..........................................................................................................
Cockpit app navigation menu8.3.1 27...............................................................................................................
Managing components8.4 27........................................................................................................................
Adding component8.4.1 27..............................................................................................................................
Deleting a component8.4.2 28..........................................................................................................................
Connecting component with multiple devices8.4.3 28.........................................................................................
Table of contents
5C-Leg 3C98-3/3C88-3
Table of contents

Use9 28......................................................................................................................................................................
Movement patterns in basic mode (mode 1)9.1 28...........................................................................................
Standing9.1.1 28............................................................................................................................................
Stance function9.1.1.1 28...................................................................................................................................
Walking9.1.2 29.............................................................................................................................................
Sitting down9.1.3 29.......................................................................................................................................
Sitting9.1.4 29................................................................................................................................................
Sitting function9.1.4.1 30...................................................................................................................................
Standing up9.1.5 30.......................................................................................................................................
Walking up stairs9.1.6 30................................................................................................................................
Walking down stairs9.1.7 30............................................................................................................................
Walking down a ramp9.1.8 31..........................................................................................................................
Walking down flat steps9.1.9 31.......................................................................................................................
Kneeling9.1.10 31............................................................................................................................................
Changing prosthesis settings9.2 31...............................................................................................................
Changing the prosthesis setting using the cockpit app9.2.1 32............................................................................
Overview of adjustment parameters in basic mode9.2.2 32..................................................................................
Overview of adjustment parameters in MyModes9.2.3 32.....................................................................................
Switching off the product9.3 33.....................................................................................................................
Turning Bluetooth on the prosthesis on/off9.4 33.............................................................................................
Switching Bluetooth off/on using the cockpit app9.4.1 33....................................................................................
Querying the prosthesis status9.5 34..............................................................................................................
Query status through cockpit app9.5.1 34.........................................................................................................
Status display in the cockpit app9.5.2 34...........................................................................................................
MyModes10 34............................................................................................................................................................
Switching MyModes with the cockpit app10.1 34..............................................................................................
Switching MyModes using motion patterns10.2 35............................................................................................
Switching from a MyMode back to basic mode10.3 35.......................................................................................
Additional operating states (modes)11 36..............................................................................................................
Empty battery mode11.1 36.............................................................................................................................
Mode for charging the prosthesis11.2 36..........................................................................................................
Safety mode11.3 36.......................................................................................................................................
Overheating mode11.4 36...............................................................................................................................
Storage and bleeding12 37.......................................................................................................................................
Cleaning13 37.............................................................................................................................................................
Maintenance14 37......................................................................................................................................................
Identification of the product by the Service Center14.1 37..................................................................................
Legal information15 37..............................................................................................................................................
Liability15.1 37..............................................................................................................................................
Trademarks15.2 38........................................................................................................................................
CE conformity15.3 38.....................................................................................................................................
Local Legal Information15.4 38.......................................................................................................................
Technical data16 39...................................................................................................................................................
Appendices17 41........................................................................................................................................................
Symbols Used17.1 41....................................................................................................................................
Operating states/error signals17.2 42..............................................................................................................
Signals for operating states17.2.1 42..................................................................................................................
Warnings/error signals17.2.2 42........................................................................................................................
Error messages while establishing a connection with the cockpit app17.2.3 44........................................................
Status signals17.2.4 44.....................................................................................................................................
Directives and manufacturer’s declaration17.3 45..............................................................................................
Electromagnetic environment17.3.1 45................................................................................................................
6 C-Leg 3C98-3/3C88-3
Table of contents

1 Foreword
INFORMATION
Date of last update: 2018-03-19
►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 "C-Leg" is called the product/prosthesis/knee joint/component in the following.
These instructions for use provide you with important information on the use, adaptation and handling of the
product.
Only put the product into use in accordance with the information contained in the accompanying documents sup
plied.
2 Product description
2.1 Design
The product consists of the following components:
1. Proximal pyramid adapter
2. LED (blue) as indicator for the Bluetooth connec
tion
3. Flexion stops 8° (already installed on delivery)
4. Battery and cover caps
5. Hydraulic unit
6. Charging receptacle cover
7. Charging receptacle
8. Distal tube clamp screws
2.2 Function
This product features microprocessor control of the stance and swing phase.
The microprocessor uses the measurements of an integrated sensor system as a basis to control a hydraulic unit
that influences the damping behaviour of the product.
These sensor data are updated and evaluated 100 times per second. As a result, the behaviour of the product is
adapted to the current motion situation (gait phase) dynamically and in real time.
Thanks to the microprocessor-controlled stance and swing phase, the product can be individually adapted to the
needs of the patient.
In order to do so, the product is configured with the "4X440=* C-Soft-Plus" 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34).
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36).
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36).
The microprocessor-controlled hydraulic unit offers the following advantages
• Approximation of the physiological gait pattern
7C-Leg 3C98-3/3C88-3
Foreword

• Stability while standing and walking
• Adaptation of product characteristics to various surfaces, inclines, gait situations and walking speeds
2.3 Combination possibilities
This product can be combined with the following Ottobock components:
Adapters
• 4R104=60 double adapter, sliding • 4R104=75 double adapter, sliding
• Rotation adapter: 4R57, 4R57=*
• 4R41 lamination anchor with pyramid receiver
• 4R111 lamination anchor with pyramid receiver
• 4R89 lamination anchor with pyramid adapter
• 4R116 lamination anchor with pyramid adapter
• 4R43 lamination anchor with threaded connector
• 4R111=N lamination anchor with threaded connect
or
• 4R40 torsion adapter
• 4R118 adapter plate
Tube adapter
• 2R57 tube adapter
• 2R67 tube adapter with torsion unit
Cosmetic cover/protector
• Foam cover: 3S26
• 4X860=* C-Leg Protective Cover (w/o shield)
Prosthetic feet
The maximum allowable patient weight depends on the foot size.
• 1D10 Dynamic foot
• 1D11 Dynamic foot (women)
• 1M10 Adjust
• 1C10 Terion
• Terion K2: 1C11
• 1A30 Greissinger plus
• 1C30 Trias
• 1D35 Dynamic Motion
• 1C40 C-Walk
• 1C60 Triton
• 1C61 Triton Vertical Shock
• 1C62 Triton Harmony
• 1C63 Triton Low Profile
• 1C64 Triton Heavy Duty
• 1E56 Axtion
• 1E57 Lo Rider
• 1B1 Meridium
• Meridium: 1B1-2
• 1C66 Triton smart ankle
Depending on the patient's weight, this knee joint may be combined with the prosthetic feet from the Triton
range (1C60 through 1C66) and the 1B1 Meridium and 1B1-2 Meridium prosthetic feet in the following foot
sizes only (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 100kg (up to 220lbs) 21 to 30
(24 to 29 with 1B1, 1B1-2)
101kg to 125kg (221lbs to 275lbs)
(not permitted for 1B1 and 1B1-2)
up to 28
(up to 26 for 1C63 and 1C66)
126kg to 136kg (276lbs to 300lbs)
(not permitted for 1C63, 1C66)
up to 26
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39).
8
Product description
C-Leg 3C98-3/3C88-3

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39).
The product is intended exclusively for use on one patient. Use of the product by another person is not approved
by the manufacturer.
Our components perform optimally when paired with appropriate components based upon weight and mobility
grades identifiable by our MOBIS classification information and which have appropriate modular connectors.
°
kg
The product is recommended for mobility grade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 136kgmax.
3.3 Indications
• For patients with knee disarticulation, transfemoral amputation and 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 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.
9C-Leg 3C98-3/3C88-3
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
CAUTION
The heading describes the source and/or the type of hazard
The introduction describes the consequences in case of failure to observe the safety instructions. Consequences
are presented as follows if more than one consequence is possible:
> E.g.: Consequence 1 in case of failure to observe the hazard
> E.g.: Consequence 2 in case of failure to observe the hazard
►This symbol identifies activities/actions that must be observed/carried out in order to avert the hazard.
4.3 General safety instructions
WARNING
Non-observance of safety notices
Personal injury/damage to the product due to using the product in certain situations.
►Observe the safety notices and the stated precautions in this accompanying document.
WARNING
Use of damaged power supply unit, adapter plug or battery charger
Risk of electric shock due to contact with exposed, live components.
►Do not open the power supply unit, adapter plug or battery charger.
►Do not expose the power supply unit, adapter plug or battery charger to extreme loading conditions.
►Immediately replace damaged power supply units, adapter plugs or battery chargers.
CAUTION
Failure to observe warning/error signals
Falling due to unexpected product behaviour because of changed damping behaviour.
►The warnings/error signals (see Page42) and corresponding change in damping settings must be observed.
CAUTION
Independent user manipulation of system components
Falling due to breakage of load-bearing components or malfunction of the product.
►Manipulations to the product other than the tasks described in these instructions for use are not permitted.
►The battery may only be handled by Ottobock authorised, qualified personnel (no replacement by the user).
►The product and any damaged components may only be opened and repaired by authorised, qualified
Ottobock personnel.
CAUTION
Mechanical stress on the product
> Falling due to unexpected product behaviour as the result of a malfunction.
> Falling due to breakage of load-bearing components.
> Skin irritation due to defects on the hydraulic unit with leakage of liquid.
►Do not subject the product to mechanical vibrations or impacts.
►Check the product for visible damage before each use.
10
Safety
C-Leg 3C98-3/3C88-3

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.
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).
11C-Leg 3C98-3/3C88-3
Safety

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 walking and getting caught on a connected battery charger.
> Falling due to unexpected behaviour of the product 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
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39).
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
C-Leg 3C98-3/3C88-3

4.6 Information on Alignment/Adjustment
CAUTION
Use of unsuitable prosthetic components
Falling due to unexpected behaviour of the product or breakage of load-bearing components.
►Use the product only in combination with components listed in the section "Combination possibilities" (see
Page8).
►If the product is to be used in water, verify that each prosthetic component is waterproof.
CAUTION
Improper assembly of the screw connections
Falling due to breakage or loosening of the screw connections.
►Clean the threads before every installation.
►Apply the specified tightening torque values for installation (see the section "Technical data").
►Observe the instructions for securing the screw connections and the use of the correct length.
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39).
►The tube clamp screws must not be secured but only tightened to the specified torque.
CAUTION
Incorrect alignment or assembly
Falling due to damage to the prosthesis components.
►Observe the alignment and assembly instructions.
CAUTION
Errors during prosthesis alignment
> Falling due to unexpected product behaviour as the result of a malfunction.
> Falling due to breakage of load-bearing components.
►At maximum flexion, it is essential to maintain a minimum distance of 3mm (1/8") between the hydraulic unit
and the socket.
►At maximum extension (reached under full load), it is essential to maintain a minimum distance of 5mm (1/5")
between the electronics/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) still occurs, contact Ottobock Customer Ser
vice.
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.
13C-Leg 3C98-3/3C88-3
Safety

CAUTION
Operator errors during the adjustment process with the adjustment software
Falling due to unexpected prosthesis behaviour.
►Do not charge the prosthesis battery during the configuration process since the prosthesis is not functional
while the battery is being charged.
►The prosthesis must not remain unattended during the configuration process while connected to the adjust
ment software and being worn by the patient.
►Observe the maximum range of the Bluetooth connection and take note that obstacles may limit this range.
►During the data transfer (PC to prosthesis) the prosthesis wearer should sit still or stand securely, and the
BionicLink PC must not be removed from the computer.
►If only temporary changes to the settings are to be made while connected to the adjustment software, these
changes must be reversed before the adjustment software is closed.
It must also be ensured that the patient does not leave the range of the Bluetooth connection with settings that
have been changed temporarily.
►Inform the patient immediately if the data connection is accidentally interrupted during the configuration pro
cess.
►The connection to the prosthesis must always be disconnected after adjustments have been completed.
►Participation in an Ottobock product training course is mandatory prior to the initial use of the product. Addi
tional product training courses may be required to qualify for software updates.
►Correctly entering the foot size, the prosthesis dimensions and the body weight are important criteria for the
quality of the fitting. If the values are too high, the prosthesis may not switch to the swing phase. If the values
are too low, the prosthesis may trigger the swing phase at the wrong time.
►If the patient uses walking aids (e.g. crutches or walking canes) during the adjustment process, readjustment
is required as soon as the patient stops using these walking aids.
►Use the online help which is integrated into the software.
►Do not pass on your personal access data.
CAUTION
Safety mode flexion resistance set too low
Falling due to unexpected product behaviour as the result of switching into safety mode.
►Safety mode flexion resistance should be configured so that it is possible to stand safely without the knee joint
buckling.
CAUTION
Using the product without calibration
Falling due to unexpected product behaviour as the result of the swing phase being initiated too early/too late.
►Use the adjustment software to carry out calibration at the beginning of static alignment optimisation and at
the end of dynamic alignment optimisation.
4.7 Information on Proximity to Certain Areas
CAUTION
Insufficient distance to HF communication devices (e.g. mobile phones, Bluetooth devices, WiFi
devices)
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
►Therefore, keeping a minimum distance of 30cm to HF communication devices is recommended.
CAUTION
Proximity to sources of strong magnetic or electrical interference (e.g. theft prevention systems, metal
detectors)
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
►Ensure that the patient is not in the vicinity of sources of strong magnetic and electrical interference during tri
al fitting (such as theft prevention systems, metal detectors...).
If this cannot be avoided, ensure at least that the patient has a safeguard when walking or standing (e.g. a
handrail or the support of another person).
14
Safety
C-Leg 3C98-3/3C88-3

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39) 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42).
►Notify the patient that resistance in the flexion and extension direction can change in case of warnings and
error signals.
►Particular caution is required when carrying children down the stairs.
CAUTION
Overheating of the hydraulic unit due to uninterrupted, increased activity (e.g. extended walking down
hill)
> Falling due to unexpected behaviour of the product because of switching into overheating mode.
> Burns due to touching overheated components.
►Be sure to pay attention when pulsating vibration signals start. They indicate the risk of overheating.
►As soon as these pulsating vibration signals begin, the activity level has to be reduced so the hydraulic unit
can cool down.
►Full activity may be resumed after the pulsating vibration signals stop.
►If the activity level is not reduced in spite of the pulsating vibration signals, this could lead to the hydraulic ele
ment overheating and, in extreme cases, cause damage to the product. In this case, the product should be
inspected by an authorised Ottobock Service Centre.
15C-Leg 3C98-3/3C88-3
Safety

CAUTION
Overloading due to unusual activities
> Falling due to unexpected product behaviour as the result of malfunction.
> Falling due to breakage of load-bearing components.
> Skin irritation due to defects on the hydraulic unit with leakage of liquid.
►The product was developed for everyday use and must not be used for unusual activities. These unusual activ
ities include, for example, extreme sports (free climbing, paragliding, etc.).
►Careful handling of the product and its components not only increases their service life but, above all, ensures
the patient's personal safety!
►If the product and its components have been subjected to extreme loads (e.g. due to a fall, etc.), then the
product must be inspected for damage immediately. If necessary, forward the product to an authorised
Ottobock Service Centre.
CAUTION
Improper mode switching
Falling due to unexpected behaviour of the product because of changed damping behaviour.
►Ensure that the patient stands securely during all switching processes.
►Inform the patient that the changed damping characteristics have to be verified after switching and feedback
from the acoustic signal emitter must be observed.
►Switching back to basic mode is mandatory once the activities in MyMode have been completed.
►If required, take the weight off the product and correct the switching.
CAUTION
Improper use of the stance function
Falling due to unexpected product behaviour because of changed damping behaviour.
►Make sure that the patient is standing safely when using the stance function and checks the lock of the knee
joint before placing his/her full weight on the prosthesis.
►Inform the patient whether and in what way the stance function was configured in the adjustment software.
Information on the stance function see Page28.
CAUTION
Quickly pushing the hip forward with the prosthesis extended (e.g. serve while playing tennis)
> Falling due to unexpected activation of the swing phase.
►Note that the knee joint may flex unexpectedly when the hip is pushed forward quickly while the prosthesis is
extended.
►If the patient participates in sports where this movement pattern can occur, configure corresponding
MyModes using the adjustment software. For further information about the MyModes, see the section
'MyModes' (see Page34).
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42) have to be observed.
►Particular caution is necessary when using a bicycle without a freewheel (with a fixed gear).
CAUTION
Safety mode cannot be activated due to malfunction caused by water penetration or mechanical damage
Falling due to unexpected product behaviour because of changed damping behaviour.
►Using the product when it is defective is prohibited.
►The product must be inspected by an authorised Ottobock Service Centre.
16
Safety
C-Leg 3C98-3/3C88-3

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42) 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.
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.
4.11 Information on the use of a mobile device with the cockpit app
CAUTION
Improper use of the device
Falling due to altered damping behaviour as a result of unexpected switching into MyMode.
►Use the instructions for use (user) to instruct the patient on proper use of the device with the cockpit app.
CAUTION
Independently applied changes or modifications made to the device
Falling due to altered damping behaviour as a result of unexpected switching into MyMode.
►Do not make any independent changes to the hardware of the device.
►Do not make any independent changes to the software/firmware of the device which are not included in the
update function of the software/firmware.
CAUTION
Improper mode switching with the device
Falling due to unexpected product behaviour because of changed damping behaviour.
►Ensure that the patient stands securely during all switching processes.
►Inform the patient that the changed damping characteristics have to be verified after switching, and feedback
from the acoustic signal emitter and the device display must be observed.
►Switching back to basic mode is mandatory once the activities in MyMode have been completed.
NOTICE
Destruction of the device due to falling or penetration of water
Malfunction of the device.
►Note the instructions for use for the device.
►If it should no longer be possible to switch back from a MyMode to basic mode, the component can only be
switched back to basic mode by using a movement pattern (see Page35) or by connecting/disconnecting the
inductive battery charger.
17C-Leg 3C98-3/3C88-3
Safety

NOTICE
Failure to observe the system requirements for the installation of the cockpit app
Malfunction of the device.
►Install the cockpit app only on the operating systems listed in the section "System requirements" (see
Page25).
INFORMATION
The illustrations in these instructions for use are only examples and may deviate from the respective mobile device
being used and the version.
5 Scope of Delivery and Accessories
Scope of Delivery
• 1pc. 3C88-3 C-Leg knee joint (with threaded connector) or
• 1pc. 3C98-3 C-Leg (with pyramid adapter)
• 1pc. 2R57 titanium tube adapter short, Ø34mm, or
1pc. 2R67 tube adapter with torsion unit, Ø34mm
• 1 pc. 757L16* power supply
• 1 pc. 4E50 Battery Charger for C-Leg
• 1 pc. 4H95 8° C-Leg flexion stop (already installed on delivery)
• 1pc. cosmetic case for battery charger and power supply
• 1pc. 646C107 Bluetooth PIN card
• 1 pc. card holder for prosthesis passport
• 1 pc. 647F542 prosthesis passport
• 1pc. 647G1375 Instructions for use (qualified personnel)
• 1pc. 647H569, 647H569=1 instructions for use (user)
Cockpit app for download from the website:
http://www.ottobock.com/cockpitapp
• iOS app "Cockpit 4X441- IOS=V*"
• Android app "Cockpit 4X441-Andr=V*"
Accessories
The following components are not included in the scope of delivery and may be ordered separately:
• 4H105 knee extender for bench alignment (see Page21)
• 4H106 16° C-Leg flexion stop
• 3S26 cosmetic foam cover
• 4P862 C-Leg guard
• 4X860=* C-Leg Protective Cover (w/o shield)
• 4P863* Shield Insert
• 4X156 Charger Extension Cable – Ankle
• 4X158 charger extension cable – ankle, long
• 4X157 Charger Extension Cable – Knee
• "4X440=* C-Soft Plus" adjustment software
6 Charging the battery
The following points must be observed when charging the battery:
• With uninterrupted walking, the capacity of the fully charged battery is sufficient for at least 16 hours. It lasts
about 2 days with average use.
• We recommend charging the product once a day when used by the patient on a daily basis.
• When used daily, the complete charging unit (power supply – battery charger) may remain plugged into the
wall socket.
• For the maximum operating time with one battery charge, disconnecting the battery charger from the product
only immediately before using the product is recommended.
18
Scope of Delivery and Accessories
C-Leg 3C98-3/3C88-3

• The battery should be charged until the yellow LED on the battery charger turns off prior to initial use, and for
at least 4 hours. This calibrates the charge level indicator via the Cockpit app and by turning over the prosthes
is.
If the battery charger is disconnected from the prosthesis too soon, the charge level indicator via the Cockpit
app and by turning over the prosthesis may not correspond to the actual charge level.
• Use the 757L16* power supply and 4E50* battery charger to charge the battery.
• The battery may discharge while the product is not being used.
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, four-pin plug of the charging cable to the OUT receptacle on the battery 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) Connect the round, three-pin plug of the power supply to the 12V receptacle on the battery 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.
4) Plug the power supply unit into the wall socket.
→The green LED on the back of the power supply and the green LED on the battery charger light up (see
fig.3).
→If the green LED on the power supply and the green LED on the battery charger do not light up, there is an
error (see Page42).
6.2 Charging the prosthesis battery
1) Open the charging receptacle cover.
2) Connect the charging plug to the charging receptacle of the product.
INFORMATION: Take note of the plug direction!
→The correct connection of the battery charger to the product is indicated by
feedback (see Page42).
3) The charging process starts.
→Once the product battery is fully charged, the yellow LED on the battery
charger turns off.
4) Disconnect the product after the charging process is complete.
→A self-test is performed. The product is operational only after corresponding
feedback (see Page44).
5) Close the charging receptacle cover.
6.3 Display of the current charge level
INFORMATION
The charge level cannot be displayed during the charging process.
19C-Leg 3C98-3/3C88-3
Charging the battery

6.3.1 Display of battery charge level without additional devices
1) Rotate the prosthesis 180° (the sole of the foot must 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 65% to 80%
3x short 50% to 65%
2x short 35% to 50%
1x short 3x long 20% to 35%
1x short 5x long less than 20%
INFORMATION
If the Volume parameter is set to '0' in the Cockpit app, there are no beep signals (see Page31).
6.3.2 Display of the current charge level using the Cockpit app
Once the Cockpit app has been started, the current charge level is displayed in the bottom line of the screen:
1. 38% – Charge level of battery for currently connected component
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21).
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.
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.
20
Preparation for use
C-Leg 3C98-3/3C88-3