Otto Bock C-Leg 3C98-3 Instructions For Use Manual
  1. Manuals
  2. Brands
  3. Otto Bock Manuals
  4. Medical Equipment
  5. C-Leg 3C98-3
  6. Instructions for use manual

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

Hide thumbs Also See for C-Leg 3C98-3:
Table of Contents

Advertisement

Quick Links

Download this manual
C-Leg 3C98-3/3C88-3
Instructions for use (qualified personnel) .................................................................
7

Advertisement

Table of Contents
loading

Related Manuals for Otto Bock C-Leg 3C98-3

Summary of Contents for Otto Bock C-Leg 3C98-3

  • Page 1 C-Leg 3C98-3/3C88-3 Instructions for use (qualified personnel) ..............
  • Page 2 Quick Reference Guide This "Quick Reference Guide" does not replace the instructions for use 7.1.1 715H1=2 719R3 C-Leg 3C98-3/3C88-3...
  • Page 3 7.1.2 40 mm 55 mm 710D4 710D4 15Nm 7.1.4 4H95 4H95 (8°) 70Ncm C-Leg 3C98-3/3C88-3...
  • Page 4 7.1.5 5 mm 3 mm 9.4.1 7.1.6 Connection Job Specification Alignment Basic Mode C-Leg 3C98-3/3C88-3...
  • Page 5 Alignment recommendation Calibration Patient data Alignment recommendation Calibration Patient data Alignment recommendation Calibration 7.1.7 Connection Job Specification Alignment Basic Mode Stance phase Swing phase Functions Stance phase Swing phase Functions Stance phase Swing phase Functions 7.1.5 5 mm 3 mm C-Leg 3C98-3/3C88-3...
  • Page 6 | Gleichspannung en | Direct-current voltage Wrong Righi Cockpit App Use the adjustment software A successful connection between the product and the adjustment software is established Fill in the fields in the adjustment software Check the values C-Leg 3C98-3/3C88-3...

  • Page 7: Table Of Contents

    Dynamic alignment optimisation ......................7.1.9 Flexion stop ............................Optional: Installing the foam cover ......................Cockpit app ................................ System Requirements .......................... Initial connection between cockpit app and component ................8.2.1 Starting the cockpit app for the first time ....................C-Leg 3C98-3/3C88-3...
  • Page 8 Liability .............................. 15.2 Trademarks ............................15.3 CE conformity ............................. 15.4 Local Legal Information ........................Technical data ..............................Appendices ................................ 17.1 Symbols Used ............................ 17.2 Operating states/error signals ......................17.2.1 Signals for operating states ........................17.2.2 Warnings/error signals ........................C-Leg 3C98-3/3C88-3...
  • Page 9 Table of contents 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 10: Foreword

    In case of a product malfunction, safety mode makes restricted operation possible. Resistance parameters that are predefined by the product are configured for this purpose (see page 44). 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 44). C-Leg 3C98-3/3C88-3...

  • Page 11: Combination Possibilities

    Example: The build height of the "F22" prosthetic foot in size 26 is 117 mm. Therefore, the system height is: 117 mm – 18 mm = 99 mm. This is only a reference value. Therefore, measure and verify the distances on the patient before shortening the tube adapter. C-Leg 3C98-3/3C88-3...

  • Page 12: Limits For Combination Options With Prosthetic Feet

    Up to 30 116 kg to 136 kg (255 lbs to 299 lbs) Up to 27 1B1, 1B1-2 Meridium Body weight Approved foot size [cm] Up to 100 kg (up to 220 lbs) Up to 29 101 kg to 136 kg (221 lbs to 299 lbs) Up to 26 C-Leg 3C98-3/3C88-3...

  • Page 13: Combination With An Osseointegrated Implant System

    Approved for a body weight of 136 kg max. 3.3 Indications • For patients with knee disarticulation, transfemoral amputation or hip disarticulation • For unilateral or bilateral amputation • Dysmelia patients with residual limb characteristics corresponding to knee disarticulation, transfemoral ampu­ tation or hip disarticulation C-Leg 3C98-3/3C88-3...

  • Page 14: Contraindications

    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 autho­ rised for the connection to the osseointegrated implant system. C-Leg 3C98-3/3C88-3...

  • Page 15: 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 16 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" (see page 23) and "Accessories" (see page 23). C-Leg 3C98-3/3C88-3...

  • Page 17: Information On The Power Supply/Battery Charging

    ► Ensure that neither solid particles nor liquids can penetrate into the product. NOTICE Independent changes or modifications to the battery charger / charging adapter Lack of proper charging functionality due to malfunction. ► Have any changes or modifications carried out only by authorised, qualified Ottobock personnel. C-Leg 3C98-3/3C88-3...

  • Page 18: Information On Alignment/Adjustment

    (with the help of soft padding on the socket). 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 19: Information On Proximity To Certain Areas

    ► 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. C-Leg 3C98-3/3C88-3...

  • Page 20: Information On Use

    ► 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. C-Leg 3C98-3/3C88-3...
  • Page 21 ► Note that the knee joint may flex unexpectedly when the hip is pushed forward quickly while the prosthesis is extended. ► If the patient participates in sports where this movement pattern can occur, configure corresponding MyModes using the adjustment software. For further information about the MyModes, see the section 'MyModes' (see page 42). C-Leg 3C98-3/3C88-3...

  • Page 22: Notes On The Safety Modes

    ► Verify compliance with the fields of application, conditions of use and indications according to the information of the manufacturers, both for the knee joint and for the implant system. ► Note the instructions of the clinical personnel that indicated the use of the osseointegrated implant system. C-Leg 3C98-3/3C88-3...

  • Page 23: Information On The Use Of A Mobile Device With The Cockpit App

    4H106 16° C-Leg flexion stop • 3S26 cosmetic foam cover • 3F1=1 Functional cosmesis C-Leg • 99B120=* Functional stocking • 4X860=* C-Leg Protective Cover (w/o shield) • 4P862 C-Leg guard • 4P863* Shield Insert • 4X156-1 Charger Extension Cable – Ankle C-Leg 3C98-3/3C88-3...

  • Page 24: Charging The Battery

    → The green LED on the back of the power supply and the green LED on the battery charger light up (see fig. 3). → If the green LED on the power supply and the green LED on the battery charger do not light up, there is an error (see page 51). C-Leg 3C98-3/3C88-3...

  • Page 25: Charging The Prosthesis Battery

    If the Volume parameter is set to '0' in the Cockpit app, there are no beep signals (see page 39). 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: C-Leg 3C98-3/3C88-3...

  • Page 26: Preparing The Product For Use

    Bluetooth wireless connection must be established between the product and the PC using the “60X5=* BionicLink PC” Bluetooth adapter. The installation and use of the “60X5=* BionicLink PC” adapter are described in the instructions for use included with the adapter. C-Leg 3C98-3/3C88-3...

  • Page 27: Preparing The Product To Connect To The Adjustment Software

    The position of the residual limb must be taken into account when positioning the socket connector. Plumb lines in the frontal and sagittal planes (drawn from the hip joint's centre of rotation and C-Leg 3C98-3/3C88-3...

  • Page 28: Installing/Removing The Knee Extender

    Support for using of the knee extender via the adjustment software When the knee joint is connected to the C-Soft Plus adjustment software, version 1.10 or higher, correct exten­ sion of the knee joint with the help of the knee extender is shown in real time. C-Leg 3C98-3/3C88-3...

  • Page 29: Checking The Socket After Bench Alignment

    It must be at least 5 mm. INFORMATION: If the knee extender is used to verify the distance, note that this is only permissible if the 8° flexion stops are installed. C-Leg 3C98-3/3C88-3...

  • Page 30: Static Alignment Optimisation

    (laser line) runs approx. 30 mm in front of the alignment reference point (= knee axis) of the knee joint. C-Leg 3C98-3/3C88-3...

  • Page 31: 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 32: 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 33: Starting The Cockpit App For The First Time

    7. Display of and designation for 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. No existing connection to the component. C-Leg 3C98-3/3C88-3...

  • Page 34: Cockpit App Navigation Menu

    If establishing a connection to a component is not possible, perform the following steps: ► Delete the component from the Cockpit app if applicable (see the section "Deleting a component") ► Add the component again in the Cockpit app (see the section "Adding a component") C-Leg 3C98-3/3C88-3...

  • Page 35: 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 39). C-Leg 3C98-3/3C88-3...

  • Page 36: Walking

    INFORMATION: Resistance while sitting down can be changed with the Cockpit app via the parameter “Resistance” (see page 39). 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 37: Sitting Function

    4) Stand up with support from the hands while keeping weight evenly distributed on feet. 9.1.6 Walking up stairs Walking up stairs step-over-step is not possible. 1) Hold the handrail with one hand. 2) Place the foot of the sound leg on the first step. Bring up the leg with the prosthesis. C-Leg 3C98-3/3C88-3...

  • Page 38: Walking Down Stairs

    A hard impact of the knee joint on the ground should be avoided so the electronics are not damaged. Using the 4X860=* C-Leg Protective Cover or the 4P862 guard is recommended for kneel­ ing frequently. C-Leg 3C98-3/3C88-3...

  • Page 39: Changing Prosthesis Settings

    (e.g. ramps, slow walking speed, etc.). The stance function and/or the sitting function can also be activated/deactivated. Further information on the stance function (see page 35). Further information on the sitting function (see page 36). C-Leg 3C98-3/3C88-3...

  • Page 40: Overview Of Adjustment Parameters In Mymodes

    Volume 0–4 0–4 Volume of beep signal for confirmation tones (e.g. when checking the charge level, switch­ ing MyModes). The “0” setting deactivates the audible feedback signals. However, warning signals are still generated if errors occur. C-Leg 3C98-3/3C88-3...

  • Page 41: Switching Off The Product

     symbol appears on the screen. 9.5 Querying the prosthesis status 9.5.1 Query status through cockpit app 1) When the component is connected, tap the  symbol in the main menu. 2) In the navigation menu, tap the entry "Status". C-Leg 3C98-3/3C88-3...

  • Page 42: Status Display In The Cockpit App

    During this time, the app must be started and used to establish a connection. If required, Bluetooth on the prosthesis can be switched on permanently afterwards (see page 41). INFORMATION If the Volume parameter is set to '0' in the Cockpit app, there are no beep signals (see page 39). C-Leg 3C98-3/3C88-3...

  • Page 43: Switching Mymodes Using Motion Patterns

    MyMode (2 times = MyMode 1, 3 times = MyMode 2). INFORMATION: If this confirmation signal does not sound, the leg with the prosthesis was not cor­ rectly repositioned and kept still. Repeat the process to correctly switch to the required mode. C-Leg 3C98-3/3C88-3...

  • Page 44: Switching From A Mymode Back To Basic Mode

    When the hydraulic unit overheats due to uninterrupted, increased activity (e.g. extended walking downhill), the flexion resistance is increased along with the rising temperature in order to counteract the overheating. When the hydraulic unit cools down, the product switches back to the settings that existed prior to overheating mode. C-Leg 3C98-3/3C88-3...

  • Page 45: Storage And Bleeding

    Before shipping, the knee head of the prosthetic knee joint has to be extended. The knee head must not be flexed! 14.1 Identification of the product by the Service Center The product may have been identified by an authorised Ottobock Service Center: Factory setting The patient-specific product settings have been reset to the state at delivery (factory setting). C-Leg 3C98-3/3C88-3...

  • Page 46: Legal Information

    Bluetooth is a registered trademark of Bluetooth SIG, Inc. 15.3 CE conformity 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 haz­...
  • Page 47 RF field in excess of Health Canada limits for the general population. 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. C-Leg 3C98-3/3C88-3...

  • Page 48: Technical Data

    Wireless technology Bluetooth 5.0 (Bluetooth Low Energy) Distance range Approx. 10 m / 32.8 ft Frequency range 2,402 MHz to 2,480 MHz Modulation GFSK Data rate (over the air) Up to 2 Mbps Maximum output power (EIRP): +4 dBm (~2.5 mW) Prosthesis battery Battery type Li-Ion C-Leg 3C98-3/3C88-3...
  • Page 49 Tube adapter on prosthetic foot 15 Nm / 133 lbf. In. Tube clamp of the knee joint 7 Nm / 62 lbf. In. Proximal prosthesis components with pyramid receiver 15 Nm / 133 lbf. In. Proximal prosthesis components with threaded connect­ 10 Nm / 89 lbf. In. Flexion stop 1 Nm / 5 lbf. In. C-Leg 3C98-3/3C88-3...

  • Page 50: Appendices

    WW – week of manufacture NNN – sequential number Lot number (PPPP YYYY WW) PPPP – plant YYYY – year of manufacture WW – week of manufacture Article number Medical device Caution, hot surface Please note the instructions for use C-Leg 3C98-3/3C88-3...

  • Page 51: 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 52 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 53 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 54 6 V in ISM and amateur frequency bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz Voltage drops IEC 61000-4-11 0% U ; 1/2 period At 0, 45, 90, 135, 180, 225, 270 and 315 degrees 0% U ; 1 period 70% U ; 25/30 periods Single phase: at 0 degrees C-Leg 3C98-3/3C88-3...
  • Page 55 CDMA 1900; 1,845 217 Hz GSM 1900; 1,970 DECT; LTE band 1, 3, 4, 25; UMTS 2,450 2,400 to 2,570 Bluetooth Pulse modula­ tion WLAN 802.11­ 217 Hz  b/g/n, RFID 2450 LTE band 7 5,240 5,100 to 5,800 WLAN 802.11­ Pulse modula­  a/n tion 5,500 217 Hz 5,785 C-Leg 3C98-3/3C88-3...
  • Page 56 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...

This manual is also suitable for:

C-leg 3c88-3

Table of Contents