Otto Bock 17KO1 Series Instructions For Use Manual
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Otto Bock 17KO1 Series Instructions For Use Manual

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

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Summary of Contents for Otto Bock 17KO1 Series

  • Page 1 C-Brace joint unit 17KO1=* Instructions for use (user) ....................
  • Page 2 order-ifu@ottobock.com Documentu 647H649 Versionu 17 SCAN ME httpsu//product-documents.ottobock.com/IFU/INT/17KO1/647H649/17/O/S/F Lassen Sie sich durch das Fachpersonal in den sicheren Gebrauch des Produkts einweisen. DE | Weitere Sprachen dieser Gebrauchsanweisung sind online verfügbar oder können kostenlos als gedrucktes Exemplar bestellt werden (siehe Seite 2). Consult qualified personnel for instructions on how to use the product safely.
  • Page 3 NO | La fagpersonell instruerer deg i sikker bruk av produktet. Flere språk for denne bruksanvisningen er tilgjengelige på nett, eller de kan bestilles som utskrevet eksemplar (se side 2). Anna ammattihenkilöstön perehdyttää itsesi tuotteen turvalliseen käyttöön. FI | Tämän käyttöohjeen muut kielet ovat saatavilla online tai niitä voi tilata maksutta painettuna versiona (katso sivu 2).

  • Page 4: Product Description

    English 1 Foreword 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 ►...
  • Page 5 2.1.1 Control panel on the joint unit Long button press: turns the component on/off (see page 29) Short button press: queries the status (see page 38) Displays the charge level of the integrated battery (see page 17) Maintenance required (see page 38) 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"...
  • Page 6 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.
  • Page 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.
  • Page 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...
  • Page 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. >...
  • Page 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.
  • Page 11 Avoid remaining in the vicinity of visible or concealed theft prevention systems at the ► entrance/exit of stores, metal detectors/body scanners for people (e.g. in airports) or other sources of strong magnetic and electrical interference (e.g. high-voltage lines, transmitters, transformer stations...). If this cannot be avoided, make sure to at least have a safeguard when walking or standing (e.g.
  • Page 12 Be sure to pay attention when pulsating vibration signals start (Warnings/error signals). ► They indicate the risk of overheating. As soon as these pulsating vibration signals begin, you have to reduce the activity level so ► the hydraulic unit can cool down. Full activity may be resumed after the pulsating vibration signals stop.
  • Page 13 Always use the handrail when walking down stairs and place most of the sole of your foot on ► the stair surface. Observe the warnings/error signals (see page 38). ► Be aware that resistance in the flexion and extension direction can change in case of warn­ ►...
  • Page 14 Make sure you have been instructed in the correct use of this MyMode by the O&P profes­ ► sional and/or therapist. For information about this mode, see page 32. Switch back to basic mode once the activities in this MyMode have been completed. ►...

  • Page 15: Scope Of Delivery And Accessories

    The product must be inspected by an authorised Ottobock Service Centre. In this case, the ► contact person is your prosthetist. CAUTION Using the product in safety mode Falling due to unexpected product behaviour because of changed damping behaviour. The warnings/error signals (see page 38) have to be observed. ►...

  • Page 16: Charging The Battery

    • 1 pc. 17KO1=L C-Brace joint unit left, or 17KO1=R C-Brace joint unit right • 1 pc. Instructions for use (user) 5.2 Accessories Cockpit app for download from the website: https://www.ottobock.com/cockpitapp • “Cockpit 4X441-IOS=V*” app for iOS • “Cockpit 4X441-ANDR=V*” app for Android 6 Charging the battery The following points must be observed when charging the battery: •...
  • Page 17 6.2 Connect battery charger to the product 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! → After the displays are tested, a short beep is emitted followed by three short vibration signals.

  • Page 18: Cockpit App

    Symbol Battery charge level Charge level 5% to 10% Charge level 1% to 5% Battery empty 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: 38% –...
  • Page 19 • The language of the user interface in the Cockpit app can be changed using the adjustment software. • Depending on the version of the Cockpit app being used, the language of the user interface in the Cockpit app corresponds to the language of the mobile device on which the Cockpit app is being used.
  • Page 20 → Once the connection has been established, the data are read from the component. This pro­ cess may take up to a minute. Then the main menu appears with the name of the connected component. INFORMATION After the initial connection to the component has been established successfully and when the Bluetooth function is activated, the app will connect automatically each time it is started.
  • Page 21 7.3.1 Cockpit app navigation menu Tap the symbol in the menus to display the navigation menu. Additional settings for the connected component can be con­ figured in this menu. Product Name of the connected component MyModes Return to the main menu to switch MyModes Settings Change settings of the currently selected mode (see page 27) Status...
  • Page 22 Delete the component from the Cockpit app if applicable (see the section "Deleting a com­ ► ponent"). If present, delete the component from the Bluetooth settings on the device (unpair). ► Rest the component by connecting and disconnecting the battery charger. ►...
  • Page 23 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. 8.2 Removal INFORMATION Before sitting down, check whether adequate resistance is provided for support while sitting down.
  • Page 24 Intuitive locking of the joint The intuitive stance function recognises any situation that puts strain on the orthosis in the flexion direction but where flexion is not permitted. Examples of this include standing on uneven or slop­ ing surfaces. The joint is always locked in the flexion direction when the leg with the orthosis is not fully extended and is kept still for a brief moment.
  • Page 25 8.3.4 Sitting INFORMATION While sitting, the knee joint also switches to energy saving mode. This energy saving mode is activated regardless of whether the sitting function is activated or not. When a sitting position is maintained for more than two seconds (i.e. the thigh is close to horizontal and there is no load on the leg), the product switches the resistance in the extension direction to a minimum.
  • Page 26 8.3.6.2 Orthosis construction with movement in the ankle joint This function must be practised and executed consciously. Only by properly stepping down with the sole can the product respond correctly and permit controlled flexion. 1) Hold the handrail with one hand. 2) Position the leg with the product on the step so that as much of the sole of the foot as pos­...
  • Page 27 8.3.11 Kneeling The individual approach to kneeling down and getting up again should be developed in cooperation with the O&P professional and/or therapist. Kneeling down is supported by increased flexion resistance, which permits controlled flexion of the knee joint. 8.4 Changing orthosis settings Once an active connection to a component has been established, the settings of the respective active mode can be changed using the Cockpit app.
  • Page 28 8.4.2 Overview of adjustment parameters in basic mode The parameters in basic mode describe the dynamic behaviour of the orthosis in the gait cycle. These parameters act as basic settings for automatically adjusting the damping behaviour to the current motion situation (e.g. ramps, slow walking speed, etc.). The stance function and/or the sitting function can also be activated/deactivated.
  • Page 29 The following parameters can be modified in MyModes: Parameter Adjustment Cockpit app Meaning app setting adjustment range range Flexion resistance 0 to 100 +/- 10 of the Value for speed at which flexion resist­ increase configured ance increases as the knee angle value increases This parameter can only be changed...
  • Page 30 INFORMATION No display after switching on If the symbol does not light up after a long press of the button, the battery may be deep discharged. Charging for at least 15 minutes is required in this case. 8.6 Switching Bluetooth of the component on/off INFORMATION Bluetooth on the component must be turned on in order to use the Cockpit app.
  • Page 31 9 MyModes In addition to the MyModes "Training mode" and "Freeze position", the O&P professional can configure a MyMode "User defined" using the adjustment app. These MyModes can be selected using the Cockpit app. 9.1 Switching MyModes with the cockpit app Once a connection to an orthosis has been established, the Cockpit app can be used to switch between the MyModes.

  • Page 32: Additional Operating States (Modes)

    Switching process 1) On the screen of the device, tap the corresponding symbol to activate training mode. → A confirmation signal sounds to indicate the switch to training mode. 2) The hydraulics stabilise the joint with high flexion resistance in the stance phase and release the joint in the swing phase so that the leg can swing forward freely.
  • Page 33 10.2 Mode for charging the product The product is non-functional during charging. To switch to basic mode, the battery charger for the product must be disconnected after the bat­ tery is charged. 10.3 Safety mode The product automatically switches to safety mode if a critical fault occurs (e.g. failure of a sensor signal).

  • Page 34: Maintenance

    12 Maintenance Regular maintenance (service inspections) is mandatory in the interest of your own safety and in order to maintain operating reliability and protect the warranty, maintain basic safety and the essential performance characteristics, and ensure safety in regards to EMC. When maintenance is due, this is indicated by feedback after connecting the battery charger (see the section “Operating states/error signals”, see page 38).

  • Page 35: Technical Data

    13.3 CE conformity Only applicable for "17KO1=L C-Brace joint unit"/"17KO1=R C-Brace joint unit" Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with applicable European requirements for medical devices. The product meets the requirements of the RoHS Directive 2011/65/EU on the restriction of the use of certain hazardous substances in electrical and electronic devices.
  • Page 36 Ambient conditions Transport and storage between applications -25 °C/-13 °F to +35 °C/95 °F (without packaging) Max. 93% relative humidity, non-condensing +35°C/95°F to +70°C/158°F    Water vapour pressure up to 50 hPa Operation -10 °C/+14 °F to +40 °C/+104 °F Relative humidity 15% to 93%, non-condens­ ing, at a water vapour pressure up to 50 hPa Air pressure: 606.3 hPa (up to 4000 m without pressure equalisation) Maximum temperature that can be reached on...
  • Page 37 Power supply unit Reference number 757L16-4 Type FW8001M/12 Storage and transport in original packaging -40 °C/-40 °F to +70 °C/+158 °F 10% to 95% relative humidity, non-condensing Storage and transport without packaging -40 °C/-40 °F to +70 °C/+158 °F 10% to 95% relative humidity, non-condensing Operation 0 °C/+32 °F to +50 °C/+122 °F Max. 95% relative humidity Air pressure: 70–106 kPa (up to 3,000 m without pressure equalisation) Input voltage...
  • Page 38 In some jurisdictions it is not permissible to dispose of these products with unsor­ ted household waste. Disposal that is not in accordance with the regulations of your country may have a detrimental impact on health and the environment. Please observe the instructions of your national authority pertaining to return and collec­...
  • Page 39 • button on the control panel was pressed briefly. • The component was switched on by pressing the button. • The battery charger was disconnected from the component. • Battery charger was connected to the component. • An error was identified during use. INFORMATION No status display due to battery deep discharge If the status of the component is not displayed on the control panel, the battery may be deep dis­...
  • Page 40 Symbols Beep Vibra­ Event Required action on the signal tion control signal panel 30 x long 30 x Severe error/indication of Walking possible with restric­ long safety mode activation tions. Please note the possible (see page 33) change in flexion/extension resist­ Switch to safety mode if pos­ ance.
  • Page 41 Symbols Beep Vibra­ Event Required action on the signal tion control signal panel 4 x short at — Charging the battery outside Check whether the specified intervals of the allowable temperature ambient conditions for charging approx. range the battery were met (see 65 sec.
  • Page 42 Symbols Beep Vibra­ Event Required action on the signal tion control signal panel — — Ongo­ Total failure 1. Press and hold the button Electronic control no longer on the control panel until the possible. Safety mode active vibration signal stops (approx. or undetermined valve state.
  • Page 43 15.2.3 Error while charging the product LED on LED on bat­ Error Resolution power tery charger supply Country-specific plug adapter not Check whether the country-spe­ fully engaged on power supply cific plug adapter is fully engaged on the power supply. Non-functional socket Check socket with another elec­...
  • Page 44 Electromagnetic emissions Interference meas­ Compliance Electromagnetic environment directive urements HF emissions accord­ Group 1/class B The product uses HF energy exclusively for its ing to CISPR 11 internal functioning. Its HF emissions are therefore very low, and interference with neigh­ bouring electronic devices is unlikely. Harmonics according Not applicable –...
  • Page 45 Interference resistance against wireless communication devices Test fre­ Frequency Radio ser­ Modulation Maximum Distance Interfer­ quency band vice power [W] ence [MHz] [MHz] immunity test level [V/m] 380 to 390 TETRA 400 Pulse modu­ lation 18 Hz 430 to 470 GMRS 460, FRS 460 ± 5 kHz deviation 1 kHz sine...
  • Page 48 DM/098883 India: 62940 Hongkong: 1702435.3 USA: Patent US D871,595 Legal Manufacturer of C-Brace joint unit 17KO1=* Otto Bock Healthcare Products GmbH Brehmstraße 16 · 1110 Wien · Austria T +43-1 523 37 86 · F +43-1 523 22 64 info.austria@ottobock.com · www.ottobock.com...

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