Otto Bock C-Leg 3C98-3 Instructions For Use Manual
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Otto Bock C-Leg 3C98-3 Instructions For Use Manual

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C-Leg 3C98-3/3C88-3
Instructions for use (qualified personnel) .................................................................
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  • Page 1 C-Leg 3C98-3/3C88-3 Instructions for use (qualified personnel) ..............
  • Page 2 HR | INFORMACIJA Dodatno uz tiskane upute za uporabu priloženi su i drugi jezici na CD-u (vidi poleđinu). Na upit možete na dolje navedenoj adre­ si besplatno naručiti tiskane upute za uporabu na dotičnom jeziku. C-Leg 3C98-3/3C88-3...

  • Page 3: C-Leg 3C98-3/3C88

    Basılmış olan kullanım kılavuzuna ilave olarak CD'de daha fazla alternatif diller bulunmaktadır (bakınız zarfın arka yüzü). İstek üzerine ilgili dilde basılmış kullanım kılavuzunu aşağıda belirtilmiş olan adresten temin edebilirsiniz. Ottobock Healthcare Products GmbH Brehmstraße 16 | 1110 Wien | Austria Service-admin.vienna@ottobock.com | Fax (+43-1) 526 79 85 C-Leg 3C98-3/3C88-3...
  • Page 4 C-Leg 3C98-3/3C88-3...

  • Page 5: Table Of Contents

    Starting the cockpit app for the first time ....................Control elements for cockpit app ......................8.3.1 Cockpit app navigation menu ....................... Managing components ........................8.4.1 Adding component ..........................8.4.2 Deleting a component .......................... 8.4.3 Connecting component with multiple devices ..................C-Leg 3C98-3/3C88-3...
  • Page 6 Operating states/error signals ......................17.2.1 Signals for operating states ........................17.2.2 Warnings/error signals ........................17.2.3 Error messages while establishing a connection with the cockpit app ............17.2.4 Status signals ............................. 17.3 Directives and manufacturer’s declaration ....................17.3.1 Electromagnetic environment ........................ C-Leg 3C98-3/3C88-3...

  • Page 7: Foreword

    Empty battery mode permits safe walking when the battery is drained. Resistance parameters that are predefined by the product are configured for this purpose (see Page 36). The microprocessor-controlled hydraulic unit offers the following advantages • Approximation of the physiological gait pattern C-Leg 3C98-3/3C88-3...

  • Page 8: Combination Possibilities

    Among other things, this relates to the body weight, mobility grade, type of activity, load capacity of the implant and bone anchoring, freedom from pain under functional load and compliance with the permissible ambient conditions (see Page 39). C-Leg 3C98-3/3C88-3...

  • Page 9: Application

    The product may be fitted only by qualified personnel authorised by Ottobock after completing the corresponding training. If the product is to be connected to an osseointegrated implant system, the qualified personnel must also be authorised for the connection to the osseointegrated implant system. C-Leg 3C98-3/3C88-3...

  • Page 10: Safety

    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. C-Leg 3C98-3/3C88-3...
  • Page 11 ► In the interest of the patient's safety and in order to maintain operating reliability, the product must be ser­ viced at regular intervals. NOTICE Improper product care Damage to the product due to the use of incorrect cleaning agents. ► Clean the product with a damp cloth only (fresh water). C-Leg 3C98-3/3C88-3...

  • Page 12: Information On The Power Supply/Battery Charging

    "Technical data" contains information on the allowable temperature range (see Page 39). NOTICE Independent changes or modifications carried out to the battery charger Lack of proper charging functionality due to malfunction. ► Have any changes or modifications carried out only by Ottobock authorised, qualified personnel. C-Leg 3C98-3/3C88-3...

  • Page 13: Information On Alignment/Adjustment

    If contact between the socket and joint (hydraulic unit, frame) still occurs, contact Ottobock Customer Ser­ vice. CAUTION Insufficient insertion depth of the tube adapter Falling due to breakage of load-bearing components. ► Insert the tube adapter at least 40mm to ensure operational safety. ► The patient must be seated for length adjustments. C-Leg 3C98-3/3C88-3...

  • Page 14: Information On Proximity To Certain Areas

    ► 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). C-Leg 3C98-3/3C88-3...

  • Page 15: Information On Use

    ► If the activity level is not reduced in spite of the pulsating vibration signals, this could lead to the hydraulic ele­ ment overheating and, in extreme cases, cause damage to the product. In this case, the product should be inspected by an authorised Ottobock Service Centre. C-Leg 3C98-3/3C88-3...

  • Page 16: Notes On The Safety Modes

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

  • Page 17: Instructions For Use With An Osseointegrated Implant System

    ► If it should no longer be possible to switch back from a MyMode to basic mode, the component can only be switched back to basic mode by using a movement pattern (see Page 35) or by connecting/disconnecting the inductive battery charger. C-Leg 3C98-3/3C88-3...

  • Page 18: Scope Of Delivery And Accessories

    When used daily, the complete charging unit (power supply – battery charger) may remain plugged into the wall socket. • For the maximum operating time with one battery charge, disconnecting the battery charger from the product only immediately before using the product is recommended. C-Leg 3C98-3/3C88-3...

  • Page 19: Connecting The Power Supply And Battery Charger

    → A self-test is performed. The product is operational only after corresponding feedback (see Page 44). 5) Close the charging receptacle cover. 6.3 Display of the current charge level INFORMATION The charge level cannot be displayed during the charging process. C-Leg 3C98-3/3C88-3...

  • Page 20: Display Of Battery Charge Level Without Additional Devices

    ► For shortening the tube, use only a tube cutter. 1) Determine the required length of the tube adapter using the configuration assistant in the adjustment software. 2) Shorten the tube adapter to the determined value with the 719R3 tube cutter. C-Leg 3C98-3/3C88-3...

  • Page 21: Installing The Tube Adapter

    Plumb lines in the frontal and sagittal planes (drawn from the hip joint's centre of rotation and marked during plaster cast taking and trial fitting of the check socket) will facilitate correct positioning of the lamin­ ation anchor or socket adapter. C-Leg 3C98-3/3C88-3...

  • Page 22: Installing/Removing The Knee Extender

    1) Check whether both 8° flexion stops are mounted on the knee joint (see Page 24). 2) Turn the knee extender adjustment screw counter-clockwise, setting the knee extender to the minimum height (see fig. 4). C-Leg 3C98-3/3C88-3...

  • Page 23: Checking The Socket After Bench Alignment

    10 mm. Installing the protective cover reduces this distance by 5 mm. 7.1.6 Static alignment optimisation Static alignment can be substantially improved using the L.A.S.A.R. Posture (743L100=*). In order to achieve adequate safety while simultaneously providing easy swing phase initiation, please proceed with alignment as fol­ lows: C-Leg 3C98-3/3C88-3...

  • Page 24: Dynamic Alignment Optimisation

    Inserting the flexion stop 1) Insert both flexion stops (to the left and right of the piston rod). 2) Secure the screws with 636K13 thread lock. 3) Insert the screws. 4) Tighten the screws to 1 Nm with the 710D1 torque wrench. C-Leg 3C98-3/3C88-3...

  • Page 25: Optional: Installing The Foam Cover

    Bluetooth PIN card. The serial number begins with the letters "SN". INFORMATION If the Bluetooth PIN card with the Bluetooth PIN and serial number of the component is lost, the Bluetooth PIN can be determined using the adjustment software. C-Leg 3C98-3/3C88-3...

  • Page 26: Starting The Cockpit App For The First Time

    1. Basic Mode 7. Display and name of the currently selected mode (e.g. 1. Basic Mode) Connection to component has been established Connection to component has been interrupted. The app is attempt­ ing to re-establish the connection automatically. C-Leg 3C98-3/3C88-3...

  • Page 27: Cockpit App Navigation Menu

     symbol is displayed when the connection has been established. → Once the connection has been established, the data are read from the component. This process may take up to a minute. Then the main menu appears with the name of the connected component. C-Leg 3C98-3/3C88-3...

  • Page 28: Deleting A Component

    9.1.1.1 Stance function INFORMATION To use this function, it needs to be enabled in the adjustment software. It also has to be activated using the Cock­ pit app (see Page 32). C-Leg 3C98-3/3C88-3...

  • Page 29: Walking

    3) Move the buttocks in the direction of the backrest and lean the upper body forward. 9.1.4 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. C-Leg 3C98-3/3C88-3...

  • Page 30: Sitting Function

    → This flexes the prosthesis slowly and evenly in the knee joint. 4) Place the foot of the other leg onto the next step. 5) Place the foot of the prosthetic leg on the next step after that. C-Leg 3C98-3/3C88-3...

  • Page 31: Walking Down A Ramp

    (e.g. while becoming accustomed to the prosthesis). The O&P professional can use the adjustment software to trace these changes at the patient's next appointment. • If the settings of a MyMode are to be modified, one must first switch to this MyMode. C-Leg 3C98-3/3C88-3...

  • Page 32: Changing The Prosthesis Setting Using The Cockpit App

    9.2.3 Overview of adjustment parameters in MyModes The parameters in the MyModes describe the static behaviour of the prosthesis for a specific motion pattern such as cross-country skiing. Damping behaviour is not automatically controlled and adjusted in MyModes. C-Leg 3C98-3/3C88-3...

  • Page 33: Switching Off The Product

    1) When the component is connected, tap the  symbol in the main menu. → The navigation menu opens. 2) In the navigation menu, tap the entry "Functions". 3) Tap the entry "Deactivate Bluetooth". 4) Follow the on-screen instructions. C-Leg 3C98-3/3C88-3...

  • Page 34: Querying The Prosthesis Status

    If the Volume parameter is set to '0' in the Cockpit app, there are no beep signals (see Page 31). Once a connection to a prosthesis has been established, the cockpit app can be used to switch between the MyModes. C-Leg 3C98-3/3C88-3...

  • Page 35: Switching Mymodes Using Motion Patterns

    Before the first step, always check whether the selected mode corresponds to the required motion type. Switching process INFORMATION If the Volume parameter is set to '0' in the Cockpit app, there are no beep signals (see Page 31). C-Leg 3C98-3/3C88-3...

  • Page 36: Additional Operating States (Modes)

    Overheating mode is indicated by a long vibration every 5 seconds. The following functions are deactivated in overheating mode: • Sitting function • Display of the battery charge level without additional equipment • Switching to a MyMode • Changes to the prosthesis setting C-Leg 3C98-3/3C88-3...

  • Page 37: Storage And Bleeding

    The manufacturer will only assume liability if the product is used in accordance with the descriptions and instruc­ tions provided in this document. The manufacturer will not assume liability for damage caused by disregarding the information in this document, particularly due to improper use or unauthorised modification of the product. C-Leg 3C98-3/3C88-3...

  • Page 38: Trademarks

    Caution: Exposure to Radio Frequency Radiation. This device must not be co-located or operating in conjunction with any other antenna or transmitter. Responsible party: Otto Bock Health Care, LP 3820 West Great Lakes Drive Salt Lake City, Utah 84120-7205 USA...

  • Page 39: Technical Data

    RF field in excess of Health Canada limits for the general population; consult Safety Code 6, obtainable from Health Canada’s website http://www.hc-sc.gc.ca/rpb. Responsible party: Otto Bock Healthcare Canada Ltd. 5470 Harvester Road L7L 5N5 Burlington, Ontario Canada Phone + 1-800-665-3327 Caution: Federal law (USA) restricts this device to sale by or on the order of a practitioner licensed by law of the State in which he/she practices to use or order the use of the device.
  • Page 40 Torque values of the screw connections Using a torque wrench, tighten the corresponding screws alternately in several cycles until the specified tightening torque is reached. Screw connection Tightening torque Tube adapter on prosthetic foot 15 Nm / 133 lbf. In. C-Leg 3C98-3/3C88-3...

  • Page 41: Appendices

    Please observe the instructions of your national authority pertaining to return and collection. Declaration of conformity according to the applicable European directives Serial number Lot number Caution, hot surface Please note the instructions for use Check product settings using corresponding adjustment software Ottobock Data Station. C-Leg 3C98-3/3C88-3...

  • Page 42: Operating States/Error Signals

    10 x long 10 x long Charge level 0% Charge the battery. After the beep and vibra­ tion signals, the product switches to empty battery mode and then switches off. C-Leg 3C98-3/3C88-3...
  • Page 43 The battery is fully charged if this signal is heard. If no signal is emitted, the connection to the product is interrupted. If the connection to the product is inter­ rupted, an authorised Ottobock Service Centre must inspect the product, battery charger and power supply. C-Leg 3C98-3/3C88-3...

  • Page 44: Error Messages While Establishing A Connection With The Cockpit App

    Ottobock Service Center. Battery charge level Battery charger Battery is being charged, battery charge level is less than 50% Battery is being charged, battery charge level is over 50% C-Leg 3C98-3/3C88-3...

  • Page 45: Directives And Manufacturer's Declaration

    IEC 61000-4-6 3 V/ 3 V/ induced by high frequency 0.15 MHz to 80 MHz 0.15 MHz to 80 MHz fields 6 V frequency 6 V in ISM and amateur bands between 0.15 MHz frequency bands between and 80 MHz 0.15 MHz and 80 MHz 80 % AM at 1 kHz 80 % AM at 1 kHz C-Leg 3C98-3/3C88-3...
  • Page 46 Pulse modula­ tion 217 Hz 800 to 960 GSM 800/900, Pulse modula­ tion TETRA 800, 18 Hz iDEN 820, CDMA 850, GSM 800/900, LTE Band 5 1720 1700 to 1990 GSM 1800; Pulse modula­ tion CDMA 1900; 1845 217 Hz GSM 1900; 1970 DECT; LTE Band  1, 3, 4, 25; UMTS C-Leg 3C98-3/3C88-3...
  • Page 47 Distance [m] Interference quency band power [W] immunity test [MHz] [MHz] level [V/m] 2450 2400 to 2570 Bluetooth Pulse modula­ tion WLAN 802.11­ 217 Hz  b/g/n, RFID 2450 LTE band 7 5240 5100 to 5800 WLAN 802.11­ Pulse modula­  a/n tion 5500 217 Hz 5785 C-Leg 3C98-3/3C88-3...
  • Page 48 EP 2498726 in DE, FR, GB, IT, IS, NL, SE, TR EP 2498730 in DE, FR, GB Patents pending in Australia, Brazil, Canada, EPA, Japan, Russia and USA. Otto Bock Healthcare Products GmbH Brehmstraße 16 · 1110 Wien · Austria T +43-1 523 37 86 · F +43-1 523 22 64...

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