Otto Bock 17KO1 Series User manual

C-Brace joint unit 17KO1=*
Instructions for use (qualified personnel) ................................................................. 5

DE | INFORMATION
Zusätzlich zu der gedruckten Gebrauchsanweisung, sind auch weitere Sprachen auf CD beigelegt (siehe rückseitigen Umsch
lag). Auf Anfrage können Sie eine gedruckte Gebrauchsanweisung kostenlos in der jeweiligen Landessprache unter der unten
angegebenen Anschrift bestellen.
EN | INFORMATION
In addition to the printed Instructions for Use, additional language versions are also included on CD (see back cover). You can
order a printed version of the Instructions for Use at no charge in the respective national language at the address below.
FR | INFORMATION
Le mode d‘emploi est disponible en d‘autres langues sur CD en supplément de la version imprimée (voir au dos de la couver
ture). Vous pouvez commander gratuitement une version imprimée du mode d‘emploi dans la langue de votre choix en envoyant
votre demande à l‘adresse indiquée ci-dessous.
ES | INFORMAĆION
Aparte de las instrucciones de uso impresas, se incluye un CD con dichas instrucciones en otros idiomas (véase la solapa del
dorso). Puede solicitar de forma gratuita unas instrucciones de uso impresas en el idioma de su país a la dirección que se
indica más abajo.
IT | INFORMAZIONE
In aggiunta alle istruzioni per l‘uso in formato cartaceo, il CD contiene le istruzioni anche in altre lingue (vedere il retro della
copertina). Su richiesta, potete ordinare gratuitamente le istruzioni per l‘uso in formato cartaceo nella relativa lingua del vostro
Paese all‘indirizzo di seguito riportato.
PT | INFORMAÇÃO
Adicionalmente ao manual de utilização impresso encontra-se incluído um CD com mais idiomas (consultar a contracapa). A
pedido é possível encomendar gratuitamente um exemplar impresso do manual de utilização no respectivo idioma junto do
endereço especificado.
NL | INFORMATIE
De gebruiksaanwijzing is behalve in gedrukte vorm ook in diverse andere talen bijgevoegd op cd (zie de achterzijde van de
omslag). Een gedrukte gebruiksaanwijzing in de gewenste taal kunt u kosteloos bestellen op het hieronder vermelde adres.
SE | INFORMATION
Som komplement till den tryckta bruksanvisningen har dessutom ytterligare språk bifogats på CD (se baksidan av omslaget).
Vid efterfrågan kan du utan kostnad beställa en tryckt bruksanvisning i det respektive språket under den angivna adressen.
DA | INFORMATION
Supplerende til brugsanvisningen på papir er der også vedlagt yderligere sprog på cd (se bagsiden af omslaget). På den
oplyste adresse nedenfor kan du bestille en gratis brugsanvisning på papir på det pågældende sprog.
NO | INFORMASJOU
I tillegg til den trykte bruksanvisningen er flere språk vedlagt på CD (se på baksiden omslaget). Ved forespørsel kan du bestille
en gratis trykt bruksanvisning i det gjeldende språket via adressen nedenfor.
FI | TIEDOT
Painetun käyttöohjeen lisäksi tarjoaa oheinen CD-levy käyttöön myös lisää kieliä (katso kansilehden takapuoli). Painettu
käyttöohje kunkin maan omalla kielellä on pyynnöstä tilattavissa maksutta alla ilmoitetusta osoitteesta.
CZ | INFORMACE
Kromě této vytištěné verze návodu k použití jsou na přiloženém CD k dispozici také další jazykové verze překladu (viz zadní
strana obalu). V případě požadavku si můžete na níže uvedené adrese zdarma objednat vytištěný návod k použití v příslušném
jazyce.
PL | INFORMACJA
Dodatkowo do wydrukowanej instrukcji użytkowania dołączono na CD wersję w innych językach (patrz tył okładki). Na żądanie
istnieje możliwość zamówienia bezpłatnie pod podanym poniżej adresem wydrukowanej instrukcji użytkowania w języku danego
kraju.
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.
2 C-Brace joint unit 17KO1=*

Ottobock Healthcare Products GmbH
Brehmstraße 16 | 1110 Wien | Austria
[email protected] | Fax [phone]
3C-Brace joint unit 17KO1=*

4 C-Brace joint unit 17KO1=*

Foreword1 8..............................................................................................................................................................
Product description2 8............................................................................................................................................
Design2.1 8.................................................................................................................................................
Control panel on the joint unit2.1.1 9.................................................................................................................
Function2.2 9..............................................................................................................................................
Combination possibilities2.3 9.......................................................................................................................
Application3 10.........................................................................................................................................................
Indications for use3.1 10...............................................................................................................................
Conditions of use3.2 10................................................................................................................................
Indications3.3 10.........................................................................................................................................
Contraindications3.4 10................................................................................................................................
Absolute Contraindications3.4.1 10..................................................................................................................
Relative Contraindications3.4.2 10....................................................................................................................
Qualification3.5 10.......................................................................................................................................
Qualification of the O&P professional 3.5.1 10...................................................................................................
Qualifications of the therapist or nursing staff3.5.2 10.........................................................................................
Safety4 11..................................................................................................................................................................
Explanation of warning symbols4.1 11............................................................................................................
Structure of the safety instructions4.2 11........................................................................................................
General safety instructions4.3 11...................................................................................................................
Information on the Power Supply/Battery Charging4.4 13.................................................................................
Battery charger information4.5 13..................................................................................................................
Information on Alignment/Adjustment4.6 14....................................................................................................
Notes on applying the product4.7 15..............................................................................................................
Information on Proximity to Certain Areas4.8 15...............................................................................................
Information on Use4.9 16..............................................................................................................................
Notes on the movement patterns4.10 17...........................................................................................................
Notes on the safety modes4.11 19...................................................................................................................
Information on the use of a mobile device with the cockpit app4.12 19.................................................................
Scope of Delivery and Accessories5 20................................................................................................................
Charging the battery6 20.........................................................................................................................................
Connecting the power supply and battery charger6.1 21..................................................................................
Connect battery charger to the product6.2 21..................................................................................................
Display of the current charge level6.3 22.........................................................................................................
Display of battery charge level without additional devices6.3.1 22.........................................................................
Display of the current charge level using the Cockpit app6.3.2 22........................................................................
Display of the current charge level using the adjustment app6.3.3 22....................................................................
Display of the current charge level during the charging process6.3.4 22................................................................
Preparation for use7 23...........................................................................................................................................
Assembling/disassembling the joint unit on the orthosis7.1 23...........................................................................
"C-Brace Setup" adjustment app8 24....................................................................................................................
System requirements8.1 24...........................................................................................................................
Starting the adjustment app8.2 24..................................................................................................................
Establishing the connection between the adjustment app and component8.3 25..................................................
Connecting to the component8.3.1 25...............................................................................................................
Changing the units for weight and length8.4 25...............................................................................................
Entering patient data8.5 26...........................................................................................................................
Calibration (zero setting)8.6 26......................................................................................................................
Stance phase8.7 27.....................................................................................................................................
Sitting function8.7.1 27...................................................................................................................................
Stance function8.7.2 27...................................................................................................................................
Optimisation while walking on the level8.8 28..................................................................................................
Table of contents
5C-Brace joint unit 17KO1=*
Table of contents

MyModes8.9 28...........................................................................................................................................
Basic mode8.9.1 28........................................................................................................................................
MyMode "Training mode"8.9.2 28....................................................................................................................
MyMode "Freeze position"8.9.3 29...................................................................................................................
MyMode "User defined"8.9.4 29.......................................................................................................................
Preferences8.10 29........................................................................................................................................
Configuration of the Cockpit app8.11 30..........................................................................................................
Data overview8.12 31.....................................................................................................................................
Navigation menu of the adjustment app8.13 31..................................................................................................
Cockpit app9 32........................................................................................................................................................
System Requirements9.1 32..........................................................................................................................
Initial connection between cockpit app and prosthesis9.2 32.............................................................................
Starting the cockpit app for the first time9.2.1 32................................................................................................
Control elements for cockpit app9.3 33..........................................................................................................
Cockpit app navigation menu9.3.1 34...............................................................................................................
Managing components9.4 34........................................................................................................................
Adding component9.4.1 34..............................................................................................................................
Deleting a component9.4.2 35..........................................................................................................................
Connecting component with multiple devices9.4.3 35.........................................................................................
Use10 36......................................................................................................................................................................
Application10.1 36.........................................................................................................................................
Removal10.2 36.............................................................................................................................................
Movement patterns in basic mode (mode 1)10.3 37...........................................................................................
Standing10.3.1 37............................................................................................................................................
Walking10.3.2 37.............................................................................................................................................
Sitting down10.3.3 37.......................................................................................................................................
Sitting10.3.4 37................................................................................................................................................
Standing up10.3.5 38.......................................................................................................................................
Walking down stairs10.3.6 38............................................................................................................................
Orthosis construction with rigid ankle joint or dorsal spring element10.3.6.1 38..........................................................
Orthosis construction with movement in the ankle joint10.3.6.2 38............................................................................
Walking up stairs10.3.7 39................................................................................................................................
Walking up a ramp10.3.8 39..............................................................................................................................
Walking down a ramp10.3.9 39..........................................................................................................................
Walking down flat steps10.3.10 39.......................................................................................................................
Kneeling10.3.11 39............................................................................................................................................
Changing orthosis settings10.4 39...................................................................................................................
Changing the orthosis settings using the Cockpit app10.4.1 40.............................................................................
Overview of adjustment parameters in basic mode10.4.2 40..................................................................................
Overview of adjustment parameters in MyModes10.4.3 41.....................................................................................
Switching the product on/off10.5 41.................................................................................................................
Switching Bluetooth of the component on/off10.6 42..........................................................................................
Switching off Bluetooth10.6.1 42........................................................................................................................
Switching on Bluetooth10.6.2 42........................................................................................................................
Querying the status of the component10.7 42....................................................................................................
Query status through cockpit app10.7.1 42.........................................................................................................
Status display in the cockpit app10.7.2 42...........................................................................................................
Recommendations for air travel10.8 42.............................................................................................................
MyModes11 44............................................................................................................................................................
Switching MyModes with the cockpit app11.1 44..............................................................................................
Basic mode11.2 44........................................................................................................................................
MyMode "Training mode"11.3 44....................................................................................................................
MyMode "Freeze position"11.4 45...................................................................................................................
MyMode "User defined"11.5 45.......................................................................................................................
6 C-Brace joint unit 17KO1=*
Table of contents

Additional operating states (modes)12 46..............................................................................................................
Empty battery mode12.1 46.............................................................................................................................
Mode for charging the product12.2 46.............................................................................................................
Safety mode12.3 46.......................................................................................................................................
Overheating mode12.4 46...............................................................................................................................
Cleaning13 46.............................................................................................................................................................
Maintenance14 47......................................................................................................................................................
Legal information15 47..............................................................................................................................................
Liability15.1 47..............................................................................................................................................
Local Legal Information15.2 47.......................................................................................................................
CE conformity15.3 48.....................................................................................................................................
Trademarks15.4 48........................................................................................................................................
Technical data16 49...................................................................................................................................................
Appendices17 51........................................................................................................................................................
Symbols Used17.1 51....................................................................................................................................
Operating states/error signals17.2 51..............................................................................................................
Status display on the control panel17.2.1 51........................................................................................................
Error messages while establishing a connection with the cockpit app17.2.2 54........................................................
Error while charging the product17.2.3 55...........................................................................................................
Directives and manufacturer’s declaration17.3 56..............................................................................................
Electromagnetic environment17.3.1 56................................................................................................................
7C-Brace joint unit 17KO1=*
Table of contents

1 Foreword
INFORMATION
Date of last update: 2019-08-02
►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-Brace joint unit 17KO1=*" is referred to as the product/component/orthosis/joint unit below.
These instructions for use provide you with important information on the use, adjustment and handling of the
product "17KO1=* C-Brace joint unit".
More details about installing the joint unit are found in the section "Preparation for use" (see Page23).
Only put the product into use in accordance with the information contained in the accompanying documents sup
plied.
According to the manufacturer (Otto Bock Healthcare Products GmbH), the patient is the operator of the product
according to the IEC 60601-1:2005/A1:2012 standard.
2 Product description
2.1 Design
The fabricated orthosis and the course of the orthosis shell edges can be individually designed. For this reason,
the following illustration and the illustration on the cover page of these instructions for use only show one possible
version:
InsideOutside987654321
1. Thigh closure straps
2. Thigh shell
3. 17KO1=* C-Brace joint unit with control panel
4. Medial joint support
5. Lower leg closure straps
6. Lower leg shell
7. Connecting element to ankle joint.
The connection can also be established with a dorsal spring element.
8. Ankle joint
9. Foot component
8 C-Brace joint unit 17KO1=*
Foreword

2.1.1 Control panel on the joint unit
1. Long button press: turns the component on/off (see Page41)
Short button press: queries the status (see Page51)
2. Displays the charge level of the integrated battery (see Page22)
3. Maintenance required (see Page51)
4321
4. Long button press: turns the Bluetooth function on/off (see Page42).
Short button press: if the Bluetooth function is on, the component becomes "visible"
for about 2 minutes so it can be detected by another device such as a smartphone.
Under the cover at the end of the control panel: Charging receptacle to connect the
battery charger (see Page20)
2.2 Function
The product is an orthopaedic device that makes everyday activities such as standing and walking possible or easi
er for the patient. If the patient's activity level increases in the course of use, adjustments may be required.
Changes will also have to be made if the patient's physical condition worsens and more support from the product
is needed.
This product features microprocessor control of the stance and swing phase (SSCO).
The microprocessor uses the measurements of an integrated sensor system as a basis to control a hydraulic unit
that influences the extension and flexion resistance of the product.
These sensor data are updated and evaluated 100 times per second. As a result, the behaviour of the product is
adapted to the current motion situation (gait phase) dynamically and in real time.
Thanks to the microprocessor-controlled stance and swing phase, the product can be individually adapted to the
needs of the patient.
For this purpose, the product is configured with the "C-Brace Setup" adjustment app using a tablet.
The product features MyModes for special motion types (e.g. cycling ...). These are pre-configured using the
adjustment app and can be activated using the Cockpit app (see Page44).
In case of an error in the sensor system, hydraulic control or when the battery is empty, safety mode makes restric
ted operation possible. Resistance parameters that are predefined by the product are configured for this purpose
(see Page46).
The microprocessor-controlled hydraulic unit offers the following advantages
• Approximation of the physiological gait pattern
• Stability while standing and walking
• Adaptation of product characteristics to various surfaces, inclines, gait situations and walking speeds
Essential performance of the product
• Stability in the stance phase
2.3 Combination possibilities
• 17KF100=16* C-Brace medial support
• 17LA3N ankle joint
• 17AO100=* ankle joint
• Individually fabricated spring element, at the discretion of the O&P professional, as connection to the foot com
ponent
Depending on the patient weight, the following possible combinations with the 17LA3N or 17AO100 ankle joint are
permitted:
9C-Brace joint unit 17KO1=*
Product description

<55kg 55 - 85kg 85 - 110kg 110 - 125kg
17AO100 17AO100 17AO100 –Unilateral ankle
joint 17LA3N=20 – – –
17AO100 17AO100 17AO100 17AO100
17LA3N=20 17LA3N=20 17LA3N=20 –
Bilateral ankle joint
17LA3N=16 17LA3N=16 – –
The following possible combinations are recommended
<55kg 55 - 85kg 85 - 110kg 110 - 125kg
Unilateral ankle
joint
17LA3N=20 17AO100 17AO100 –
Bilateral ankle joint – 17LA3N=16 17LA3N=20 17AO100
3 Application
3.1 Indications for use
The product is intended solely for orthotic fittings of the lower limbs.
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.), sports activities that involve
jumping, sudden movements or fast sequences of steps (e.g. basketball, badminton, sporty riding).
Permissible ambient conditions are described in the technical data (see Page49).
The product is intended exclusively for use on one patient. Use of the product by another person is not approved
by the manufacturer.
3.3 Indications
• Unilateral or bilateral lower limb paresis or flaccid paralysis, e.g. due to post-polio syndrome, traumatic paresis
including paraplegia.
• Physical prerequisites such as muscle status, joint mobility and possible axis deviations are crucial and proper
control of the orthosis must be guaranteed.
• The user must fulfil the physical and mental requirements for perceiving optical/acoustic signals and/or mech
anical vibrations
• The existing muscle strength of the hip extensors and flexors must permit the controlled swing-through of the
limb (compensation using the hip is possible).
3.4 Contraindications
3.4.1 Absolute Contraindications
• Flexion contracture in the knee and/or hip joint in excess of 10°
• Knee varus/valgus malposition in excess of 10°
• Moderate to severe spasticity
• Leg length discrepancy in excess of 15cm
• Orthoprosthesis
• Body weight over 125 kg / 275 lbs
3.4.2 Relative Contraindications
• Moderate spasticity
3.5 Qualification
3.5.1 Qualification of the O&P professional
The fitting of a patient with the product may only be carried out by O&P professionals who have been authorised
with the corresponding Ottobock training.
3.5.2 Qualifications of the therapist or nursing staff
The therapists or nursing staff must be trained in handling the product. Training must be carried out by the author
ised orthopaedic technician.
10
Application
C-Brace joint unit 17KO1=*

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51) and corresponding change in damping settings must be observed.
CAUTION
Penetration of dirt and moisture into components of the orthosis
> Falling due to unexpected behaviour of the orthosis as a result of malfunction.
> Falling due to breakage of load-bearing components.
►Ensure that neither solid particles, foreign bodies nor liquids penetrate the orthosis components.
►The orthosis components are protected against splashed water from all directions.
►However, the orthosis components are not protected against submersion, jets of water and steam.
►If water has penetrated the components of the orthosis, remove the straps and pads if possible and allow the
components to dry.
►In case of a malfunction after drying, the orthosis must be inspected by an authorised Ottobock Service
Centre.
►Always close the charging receptacle with the protective cap after disconnecting the charging cable.
11C-Brace joint unit 17KO1=*
Safety

CAUTION
Independent manipulations on the joint unit and orthosis components
Falling due to the breakage of load-bearing components or malfunction of the orthosis.
►Manipulations on the joint unit and orthosis components 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 joint unit and orthosis components may only be opened and repaired by authorised, qualified Ottobock
personnel.
CAUTION
Use of the product when battery charge level is too low
Falling due to unexpected behaviour of the product because of changed damping behaviour.
►Check the current charge level before use and charge the product 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
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 on the joint unit and orthosis components used
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. Further information is found in the section "Maintenance" (see Page47).
►Also observe the service intervals and maintenance instructions for the orthosis components used.
CAUTION
Use of unapproved accessories
> Falling due to product malfunction as a result of reduced interference resistance.
> Interference of other electronic devices due to increased emissions.
►Use the product only in combination with the accessories, signal converters and cables listed in the sections
"Scope of delivery" (Scope of delivery) and "Accessories" (Accessories).
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
Movement noises of the joint unit
When using orthotic joints, servomotor, hydraulic, pneumatic or brake load dependent control functions can
cause movement noises. This kind of noise is normal and unavoidable. It generally does not indicate any prob
lems. If movement noises increase noticeably during the lifecycle of the orthosis, the orthosis should be inspected
promptly by an authorised Ottobock Service Centre.
12
Safety
C-Brace joint unit 17KO1=*

4.4 Information on the Power Supply/Battery Charging
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.
CAUTION
Charging while wearing the product
> Falling due to walking and getting caught on the connected battery charger.
> Falling due to unexpected product behaviour because of changed damping behaviour.
►Inform the patient that the product may only be charged while sitting down.
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49).
NOTICE
Independent changes or modifications carried out to the battery charger
Lack of proper charging functionality due to malfunction.
►Have any changes or modifications carried out only by Ottobock authorised, qualified personnel.
INFORMATION
Depending on the battery charge level, the battery charger can warm up considerably during the charging pro
cess. This is not a malfunction.
13C-Brace joint unit 17KO1=*
Safety

4.6 Information on Alignment/Adjustment
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.
►Before installing the joint unit and joint mechanism, the screws must be secured before they are tightened to
the specified tightening torque (see the section "Technical data" see Page49).
CAUTION
Operator errors during the adjustment process with the adjustment app
Falling due to unexpected orthosis behaviour.
►Do not charge the orthosis battery during the adjustment process since the orthosis is not functional while the
battery is being charged.
►The orthosis must not remain unattended during the adjustment process while connected to the adjustment
software and being worn by the patient.
►Observe the maximum range of the Bluetooth connection and note that obstacles may limit this range.
►During the data transfer (tablet to orthosis), the user should sit still or stand with support.
►If only temporary changes to the settings are to be made while connected to the adjustment app, these
changes must be reversed before the adjustment app 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 adjustment pro
cess.
►The connection to the orthosis 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 patient data and especially the body weight is an important criterion for the quality of
the fitting. If the values are too high, the orthosis may not switch to the swing phase. If the values are too low,
the orthosis may trigger the swing phase at the wrong time.
►When entering the weight and dimensions, note the settings for the units. To change the units, see the sec
tion "Changing the units for weight and length" (see Page25).
►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.
►Do not pass on your personal access data.
CAUTION
Use of unsuitable orthosis 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9).
CAUTION
Disassembling the joint unit on a standing patient
> Risk of falls due to lack of support from the product.
> Damage to the medial support.
►Disassemble the joint unit only on a sitting patient or with the orthosis taken off.
14
Safety
C-Brace joint unit 17KO1=*

4.7 Notes on applying the product
CAUTION
Foreign objects between the leg and orthosis shells
Pressure points on the leg due to foreign objects at the contact points between the leg and orthosis shells.
►Smooth out wrinkles in the padding material and clothing.
►Check the leg for pressure points.
CAUTION
Improper fit of the orthosis
Falling/skin irritation due to insufficient support/hold by the orthosis shells.
►Take the orthosis off immediately and put it back on.
►Observe the instructions for applying and removing.
CAUTION
Pinching skin in the area of the closures
Injuries and swelling due to disruption of blood circulation to the skin in the area of the closures.
►Do not over-tighten the closures when applying the product.
CAUTION
Volume fluctuations of the leg or problems with the fit of the orthosis
Injuries, friction and local pressure caused by improper fit of the orthosis shells (too firm/too loose).
►Sensitivity problems and skin damage require special attention with regard to the fit. Instruct the patient to
inspect the skin areas daily.
►The patient should consult a doctor or O&P professional if there are any signs of skin damage, even if they are
only minor.
►If the improper fit is the result of weight gain or loss, new thigh shells and lower leg shells have to be fabric
ated based on a new plaster cast.
►Check the leg for pressure points.
4.8 Information on Proximity to Certain Areas
CAUTION
Insufficient distance to HF communication devices (e.g. mobile phones, Bluetooth devices, WiFi
devices)
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
►Therefore, keeping a minimum distance of 30cm to HF communication devices is recommended.
CAUTION
Operating the product in very close proximity to other electronic devices
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
►Do not operate the product in the immediate vicinity of other electronic devices.
►Do not stack the product with other electronic devices during operation.
►If simultaneous operation cannot be avoided, monitor the product and verify proper use in the existing setup.
CAUTION
Proximity to sources of strong magnetic or electrical interference (e.g. theft prevention systems, metal
detectors)
Falling due to unexpected behaviour of the product caused by interference with internal data communication.
►Ensure that the patient is not in the vicinity of sources of strong magnetic and electrical interference during tri
al fitting (such as theft prevention systems, metal detectors...).
If this cannot be avoided, ensure at least that the patient has a safeguard when walking or standing (e.g. a
handrail or the support of another person).
►In general, monitor the product for unexpected changes in the damping behaviour when electronic or magnet
ic devices are in the immediate vicinity.
15C-Brace joint unit 17KO1=*
Safety

CAUTION
Entering a room or area with strong magnetic fields (e.g. magnetic resonance tomographs, MRT (MRI)
equipment...)
> Falling due to unexpected restriction of the product's range of motion caused by metallic objects adhering to
the magnetised components.
> Irreparable damage to the product due to the effect of strong magnetic fields.
►Make sure that the patient takes off the product before entering the room or area and stores the product out
side this room or area.
►Damage to the product caused by exposure to strong magnetic fields cannot be repaired.
CAUTION
Remaining in areas outside the allowable temperature range
Falling due to malfunction or the breakage of load-bearing product components.
►Ensure that the patient is not in areas outside the permissible temperature range (see Page49) during trial fit
ting.
4.9 Information on Use
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
Risk of pinching in the joint flexion area
> Injury due to pinching of body parts.
> Damage to garments due to pinching in the mechanism of the joint unit or medial support.
►Ensure that no body parts or garments are in this area when flexing the product.
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.
►Inform the patient that they must pay attention when pulsating vibration signals start. They indicate the risk of
overheating.
►Inform the patient that the activity level has to be reduced immediately when these pulsating vibration signals
begin, so the hydraulic unit can cool down.
►Inform the patient that full activity may be resumed after these 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 has to be
inspected by an authorised Ottobock Service Centre.
16
Safety
C-Brace joint unit 17KO1=*

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 must not be used for unusual activities. These unusual activ
ities include, for example, extreme sports (free climbing, parachuting, paragliding, etc.), sports activities that
involve jumping, sudden movements or fast sequences of steps (e.g. basketball, badminton, sporty riding).
►Careful handling of the product and its components not only increases their service life but, above all, ensures
your 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.
4.10 Notes on the movement patterns
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 their full weight on the orthosis.
►Instruct the patient in the correct use of the stance function. Information on the stance function see Page27.
CAUTION
Walking up stairs
> Falling due to foot being placed incorrectly on stair as a result of changed damping behaviour.
> Falling due to breakage of load-bearing components.
►Ensure that the patient uses the handrail when walking up stairs and places most of the sole of the foot on the
stair surface.
►Always step up with the less affected leg, followed by the leg with the product.
►If there is a connection to a foot component, support by bouncing with the product extended while walking up
stairs is not allowable and therefore has to be avoided.
►Particular caution is required when carrying children up the stairs.
CAUTION
Walking down stairs with moveable orthosis foot component
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 most of the sole
of the foot has to be set onto the stair surface.
►The warnings and error signals have to be observed (see Page51).
►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
Walking down stairs with rigid orthosis foot component
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51).
►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.
17C-Brace joint unit 17KO1=*
Safety

CAUTION
Walking down stairs and ramps
Falling due to unexpected, increased stance phase damping during the transition from walking on the level to
stairs or ramps, for example when the orthosis is in a MyMode.
►Inform the patient of the changed product behaviour, especially in the MyModes.
►Inform the patient that changed stance phase damping has to be verified before walking on stairs or ramps.
CAUTION
Lack of support from the product when walking down stairs
Falling due to unexpected product behaviour because of changed damping behaviour.
►Inform the patient that it is essential to check whether corresponding flexion of the joint is possible before
walking down stairs. If this is not possible, either the Cockpit app or turning the product off/on must be used
to switch back to basic mode.
CAUTION
Improper use of the MyMode "Training mode"
Falling due to unexpected product behaviour because of changed damping behaviour.
►Make sure that the patient is standing safely when using this MyMode and checks the lock of the knee joint
before placing their full weight on the orthosis.
►Inform the patient that the knee joint is locked in the flexion direction in this MyMode. For information about
this mode, see Page.
►Switching back to basic mode is mandatory once the activities in this MyMode have been completed.
CAUTION
Improper use of the MyMode "Freeze position"
Falling due to unexpected product behaviour because of changed damping behaviour.
►Make sure that the patient is standing safely when using this MyMode and checks the lock of the knee joint
before placing their full weight on the orthosis.
►Inform the patient that the knee joint is locked in the both the flexion and extension direction in this MyMode.
For information about this mode, see Page.
►Switching back to basic mode is mandatory once the activities in this MyMode have been completed.
CAUTION
Lack of support from the product while sitting down
Falling due to unexpected product behaviour because of changed damping behaviour.
►Inform the patient that it is essential to check whether corresponding flexion of the joint is possible before sit
ting down. If this is not possible, either the Cockpit app or turning the product off/on must be used to switch
back to basic mode.
CAUTION
Quickly pushing the hip forward with the orthosis extended
> Falling due to unexpected activation of the swing phase.
►Note that the joint may flex unexpectedly when the hip is pushed forward quickly while the orthosis is exten
ded.
►With the patient, practice movement patterns where this behaviour can occur. If the patient participates in
sports where this movement pattern can occur, configure a corresponding "user-defined MyMode" using the
adjustment app.
CAUTION
Changing the gait pattern influences activation of the swing phase
> Falling due to unexpected activation of the swing phase.
►Inform the patient that changing the gait pattern influences activation of the swing phase. Adjustment by the
O&P professional has to be repeated in this case.
18
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C-Brace joint unit 17KO1=*

4.11 Notes on the safety modes
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51) 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.
CAUTION
Using the product in safety mode
Falling due to unexpected product behaviour because of changed damping behaviour.
►The warnings/error signals (see Page51) have to be observed.
►Particular caution is necessary when using a bicycle without a freewheel (with a fixed gear).
4.12 Information on the use of a mobile device with the cockpit app
CAUTION
Improper use of the mobile device
Falling due to altered damping behaviour as a result of unexpected switching into a MyMode.
►Use the instructions for use (user) to instruct the patient on the proper handling of the mobile device with the
Cockpit app.
CAUTION
Independently applied changes or modifications made to the mobile device
Falling due to altered damping behaviour as a result of unexpected switching to a MyMode.
►Do not make any independent changes to the hardware of the mobile device on which the app is installed.
►Do not make any independent changes to the software/firmware of the mobile device that are not included in
the update function of the software/firmware.
CAUTION
Improper mode switching with the mobile 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 mobile device display must be observed.
►Switching back to basic mode is mandatory once the activities in the MyMode have been completed.
19C-Brace joint unit 17KO1=*
Safety

NOTICE
Destruction of the mobile device due to falling or penetration of water
Malfunction of the mobile device.
►If necessary, let the mobile device dry at room temperature (at least 1 day).
►Should it no longer be possible to switch back from a MyMode to basic mode, the component can only be
switched back to basic mode by turning it off/on (see Page41).
NOTICE
Failure to observe the system requirements for the installation of the Cockpit app
Malfunction of the mobile device.
►Install the Cockpit app only on the operating systems listed in the section "System requirements" (see
Page32).
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. 757L16-4 power supply
• 1 pc. 4E50-2 C-Leg battery charger
• 1pc. cosmetic case for battery charger and power supply
• 2pc. 646C107 Bluetooth PIN card
• 1 pc. 647F558 orthotic passport
• 1 pc. card holder for orthotic passport
• 1pc. 17KO1=L C-Brace joint unit left, or
17KO1=R C-Brace joint unit right
• 1pc. 647G1337 instructions for use (qualified personnel)
• 1pc. 646D1182 instructions for use (user)
• 1pc. 646D1182-1 instructions for use (user)
The following additional padding materials are recommended:
• 623P3 terry cloth padding fabric
• 623F62 SpaceTex padding fabric
Accessories
Cockpit app for download from the website: http://www.ottobock.com/cockpitapp
• iOS app "Cockpit 4X441- IOS=V*"
• Android app "Cockpit 4X441-Andr=V*"
The "C-Brace Setup" adjustment app is available for download from the Apple App Store or Google Play. Enter the
following search terms: Ottobock, C-Brace, C-Brace Setup
• iOS app "560X17-IOS=V* C-BraceSetup"
• Android app "560X17-ANDR=V* C-BraceSetup"
6 Charging the battery
The following points must be observed when charging the battery:
• Use the 757L16-4 power supply and 4E50-2 battery charger to charge the battery.
• With uninterrupted walking, the capacity of the fully charged battery is sufficient for at least 18 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.
• The battery should be charged for at least 3 hours prior to initial use.
• For the maximum operating time with one battery charge, turning the product off when it is not being used is
recommended.
20
Scope of Delivery and Accessories
C-Brace joint unit 17KO1=*