Otto Bock 17KO1 Series User manual

Instructions for use (user) ............................................................................................... 4
C-Brace joint unit 17KO1=*

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SCAN ME
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Lassen Sie sich durch das Fachpersonal in den sicheren Gebrauch des Produkts einweisen.Weitere Sprachen dieser Gebrauchsanweisung sind online verfügbar oder können kostenlos alsgedrucktes Exemplar bestellt werden (siehe Seite 2).DE |
Consult qualified personnel for instructions on how to use the product safely.These instructions for use are available in additional languages online or can be ordered as a printed copy free of charge (see page 2).EN |
FR |
IT |
ES |
Solicite ao pessoal técnico que o instrua no uso seguro do produto.Outros idiomas destas instruções de uso estão disponíveis online ou podem ser solicitados gratuitamente como um exemplar impresso (veja a página 2).PT |
Laat u door deskundig personeel uitleggen hoe u veilig met het product moet omgaan.Andere talen van deze gebruiksaanwijzing zijn online beschikbaar of kunnen gratis in gedruktevorm worden besteld (zie pagina 2).NL |
SV |
Få faguddannet personale til at vise dig, hvordan du anvender produktet på sikker vis.Denne brugsanvisning er tilgængelig på yderligere sprog online eller kan bestilles gratis som et trykt eksemplar (se side 2).DA |
2

La fagpersonell instruerer deg i sikker bruk av produktet.Flere språk for denne bruksanvisningen er tilgjengelige på nett, eller de kan bestilles somutskrevet eksemplar (se side 2).NO |
Anna ammattihenkilöstön perehdyttää itsesi tuotteen turvalliseen käyttöön.Tämän käyttöohjeen muut kielet ovat saatavilla online tai niitä voi tilata maksutta painettuna versiona (katso sivu 2).FI |
Personel fachowy powinien poinstruować użytkownika na temat bezpiecznego używania produktu.Niniejszą instrukcję używania w innych językach można przeczytać online lub zamówić bezpłatniew wersji drukowanej (patrz strona 2).PL |
Kérje meg a szakszemélyzetet, hogy tanítsa meg Önt a termék biztonságos használatára.A használati útmutató további nyelvi változatai az interneten elérhetők, vagy nyomtatott példányként ingyenesen megrendelhetők (lásd a 2. oldalt).HU |
Nechte se poučit odborným personálem ohledně bezpečného použití produktu.Další jazykové verze tohoto návodu k použití jsou k dispozici online nebo je lze zdarma objednatv tištěné podobě (viz str. 2).CS |
Uzman personelin size ürünün güvenli kullanımı hakkında bilgi vermesini sağlayın.Bu kullanım kılavuzundaki diğer diller online olarak mevcuttur veya ücretsiz basılı kopya olarak sipariş verilebilir (bkz. sayfa 2).TR |
EL |
RU |
製品の安全な使用方法については、有資格担当者の指示に従ってください。本取扱説明書のその他言語は、オンラインで入手可能ですが、印刷版も無料で注文できます（P2を参照）。JA |
由专业人员就产品的安全使用提供指导。使用说明书的其他语言版本可在线获取，也可免费订购印刷版（参见第 2 页）。ZH |
전문 기사에게 제품의 안전한 사용법을 배우십시오.
이 사용 설명서의 다른 언어는 온라인에서 볼 수 있으며 또는 인쇄본은 무료로 주문할
수 있습니다 (2 페이지 참조).
KO |
Basic UDI-DI: 406441100000000017KO1LU
3

1 Foreword English
INFORMATION
Date of last update: 2023-07-19
►Please read this document carefully before using the product and observe the safety
notices.
►Obtain instruction from the qualified personnel in the safe use of the product.
►Please contact the qualified personnel if you have questions about the product or in case of
problems.
►Report each serious incident related to the product to the manufacturer and to the relevant
authority in your country. This is particularly important when there is a decline in the health
state.
►Please keep this document for your records.
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, adaptation and
handling of the product.
Only put the product into use in accordance with the information contained in the accompanying
documents supplied.
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 instruc
tions 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
4

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2.1.1 Control panel on the joint unit
1. Long button press: turns the component on/off (see page29)
Short button press: queries the status (see page38)
2. Displays the charge level of the integrated battery (see page17)
3. Maintenance required (see page38)

4. Long button press: turns the Bluetooth function on/off (see page30).
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16)
2.2 Function
The product is an orthopaedic technology device that makes everyday activities such as standing
and walking possible or easier for the user. If the user's activity level increases in the course of
use, adjustments are required. Changes will also have to be made if the user'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 your needs.
In order to do so, the product is adjusted by the O&P professional using an adjustment app.
The product features MyModes for special motion types (e.g.cycling ...). These are pre-con
figured by the O&P professional using the adjustment software and can be activated using the
Cockpit app (see page31).
In case of an error in the sensor system, hydraulic control or when the battery is empty, safety
mode makes restricted operation possible. Resistance parameters that are predefined by the
product are configured for this purpose (see page33).
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

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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).
Possible sports activities must be discussed with the O&P professional.
Permissible ambient conditions are described in the technical data (see page35).
The product is intended exclusively for use on one user. 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, incomplete 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 sig
nals and/or mechanical 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°
• Severe spasticity
• Body weight over 125 kg / 275 lbs
3.4.2 Relative Contraindications
• Moderate spasticity
3.5 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 authorised orthopaedic technician.
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 instruc
tions. Consequences are presented as follows if more than one consequence is possible:

7
> 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
Using the orthosis while operating a vehicle
Accident due to unexpected orthosis behaviour.
►All users are required to observe their country’s national and state driving laws when operat
ing vehicles with the orthosis. For insurance purposes, drivers should have their driving abil
ity examined and approved by an authorised test centre.
►The leg on which the orthosis is worn may not be used to control the vehicle or its peripheral
components (e.g.clutch pedal, brake pedal, gas pedal...).
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 (Warnings/error signals) 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 compo
nents.
►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 pos
sible and allow the components to dry.
►In case of a malfunction after drying, the orthosis must be inspected by an authorised
Ottobock Service Centre. The O&P professional is your contact person.
►Always close the charging receptacle with the protective cap after disconnecting the char
ging cable.

8
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 replace
ment 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 on the product
> Falling due to unexpected product behaviour as the result of a malfunction.
> Falling due to breakage of load-bearing components.
> Skin irritation due to defects on the hydraulic unit with leakage of liquid.
►Do not subject the product to mechanical vibrations or impacts.
►Check the product for visible damage before each use.
CAUTION
Signs of wear and tear on the product components
Falling due to damage or malfunction of the product.
►Regular service inspections (maintenance) are mandatory in the interest of your own safety
and in order to maintain operating reliability and protect the warranty.
CAUTION
Use of unapproved accessories
> Falling due to product malfunction as a result of reduced interference resistance.
> Interference of other electronic devices due to increased emissions.
►Use the product only in combination with the accessories, signal converters and cables lis
ted in the sections "Scope of delivery" (see page15) and "Accessories" (see page16).
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).
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.

9
►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.
►Only charge the product in a sitting position while wearing it.
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35).
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 per
sonnel.
4.6 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.

10
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. Check
skin areas daily.
►Consult a physician or O&P professional in case of any signs of skin damage, even if they
are only minor.
►If the improper fit is the result of weight gain or loss, have new thigh shells and lower leg
shells fabricated based on a new plaster cast.
►Check the leg for pressure points.
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 recom
mended.
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.