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Otto Bock C-Leg Prosthetic System Instructions For Use Manual

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C-Leg Prosthetic System
Instructions for Use (Qualified Personnel)

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Summary of Contents for Otto Bock C-Leg Prosthetic System

  • Page 1 C-Leg Prosthetic System Instructions for Use (Qualified Personnel)
  • Page 2 757L16‑* 4R104=60 4R57 4R41 4R111=N 4R40 4R118 4R104=75 4R57=ST 4R43 4R111 4E50‑* 4R89 4R116 with pyramid adapter with threaded connector 3C98‑2 3C88‑2 4X160=1.2 4X150‑2 4X73 4X261 3S26 Tube adapter Tube adapter Cosmetic foam with torsion unit cover (not illustrated) 3R59 Individual cosmetic foam cover (not illustrated)

  • Page 3: Table Of Contents

    INFORMATION These Instructions for Use were updated on 13.03.2012. Table of Contents 1 Important C‑Leg Information – Intended Use ..................... 4 1.1 Medical Purpose ...................................4 1.2 Field of Application ................................4 1.3 Conditions of Use ..................................5 1.4 Qualification of the Prosthetist ...............................5 1.5 Function ....................................5 1.6 Minimum scope of delivery ..............................5 1.7 Individual minimum system components (not included in the scope of delivery) ..............5...

  • Page 4: Important C-Leg Information - Intended Use

    Explanation of Symbols used in these Instructions for Use Warnings regarding directly impending risks of severe accident or injury. DANGER Warnings regarding possible risks of severe accident or injury. WARNING Warnings regarding possible risks of accident or injury. CAUTION Warnings regarding possible technical damage. NOTICE Recommended accessories for prosthetists Torque Wrench...

  • Page 5: Conditions Of Use

    1.3 Conditions of Use INFORMATION Advise your patients of the information in this section. The C-Leg was developed for everyday activities and not for extreme sports such as free climbing, parachuting or paragliding. For the necessary environmental conditions, please see Section 3.3 “Technical Information”. The C-Leg prosthesis system is designed exclusively for use on one patient.

  • Page 6: General Safety Instructions

    General Safety Instructions CAUTION Alignment and adjustment error. During alignment and adjustment of the prosthesis, errors can occur result- ing in malfunction of the joint up to loss of function due to structural failure. This can cause the patient to fall. •...

  • Page 7: Patient Instructions

    CAUTION Transport damage. Mechanical impact or stress during transportation of the joint such as shocks and vibra- tions can lead to • defects and result in malfunction of the joint; • defects on the battery and hydraulic damper resulting in leakage of liquid; or •...
  • Page 8 CAUTION Improper use of the joint. Any kind of overloading or excessive strain as well as improper use can lead to • defects and result in malfunction of the joint; • loss of function due to structural failure; or • defects on the battery and hydraulic damper resulting in leakage of liquid. This can cause the patient to fall as well as result in skin irritation.
  • Page 9 CAUTION Self-discharge of the battery. When the joint is not in use for an extended period of time, self-discharge of the battery will result. This can lead to insufficient power supply to the electronics of the joint and result in undefined conditions.

  • Page 10: Alignment And Adjustment

    2 Alignment and Adjustment 2.1 Connecting the Tube Adapter 1 Mount the foot to the tube adapter (lightly tighten the screws). 2 Plug the tube adapter plug into the knee joint (only one polarity possible). 3 Push the protruding cable into the tube and push the tube adapter into the C-Leg. In doing so, take care to achieve the minimum insertion depth (see following table).

  • Page 11: Bench Alignment Using An Alignment Tool Such As L.a.s.a.r. / Pro.s.a. Assembly

    2.2 Bench Alignment Using an Alignment Tool such as L.A.S.A.R. / PRO.S.A. Assembly INFORMATION To align the prosthesis please proceed in two steps: First make the bench alignment using an alignment tool such as 743L200 L.A.S.A.R. Assembly / 743A200 PRO.S.A. Assembly. In a second step, the static alignment is optimized with the 743L100 L.A.S.A.R.

  • Page 12: Checking The Socket After Bench Alignment

    tures) must be taken into account and, if necessary, more flexion should be provided. Also pay attention to the ischial tuberosity to ground distance (Fig. 4). Error during alignment of the prosthesis. Errors during the alignment of the prosthesis can lead CAUTION to malfunction and insufficient fitting results of the joint up to loss of function due to structural failure.

  • Page 13: Torque Values Of The Screw Connections

    2.3 Torque Values of the Screw Connections INFORMATION The torque values for additional as well as optional system components (in item 3 below) are indicated in the Instructions for Use of those products. 15 Nm 10 Nm 15 Nm 7 Nm Using the 710D4 Torque Wrench with the 710Y2=5 Hex Bit, turn the screws alternatively to the prescribed torque so that the torque is gradually increased: 1 Tube adapter: 15 Nm...
  • Page 14 The battery is empty upon delivery. The battery of the C-Leg must therefore be charged prior to the first fitting of the patient. 1 Bend the C-Leg until it hits the stop. 2 Open plug cover. 3 Connect the 4E50-* Charger and verify the charging process (see following figures). Yellow LED flashes;...

  • Page 15: Bioniclink/Optional: Serial Data Cable

    Static alignment optimization with LASAR Posture (743L100) The static alignment can be substantially improved using L.A.S.A.R. Posture. In order to ensure appropriate stability combined with easy swing phase initiation, please proceed as follows: 1 After the self-calibration of the L.A.S.A.R. device, the load line can be measured. To do this, have the transfemo- ral amputee step onto the force sensing plate with the C-Leg and onto the height compensation plate with the other leg.

  • Page 16: C-Leg Modes

    That process also requires the 60X5 (60X4) BionicLink PC for the data transfer and the 4X180=* C-Soft (V2.4 and higher) for the parameter adjustment (see Section “2.7 C-Soft” ). 2.9 C-Leg Modes 2.9.1 1st Mode, 2nd Mode and 3rd Mode INFORMATION Advise your patients of the information in this section.
  • Page 17 Activating the 1st mode: 1 Activation of the remote control: Press key 3 and kep it pressed (Fig. 1) until the joint confirms the activation with a vibration signal. 2 Activation of the 1st mode: Within 3 seconds after activation of the remote control press key 1 and keep it pressed (Fig.
  • Page 18 Switching between 1st and 2nd modes without the remote control: 3 × in 1 second 1 second 1 Bounce up and down on the forefoot at least 3 times in one second while maintaining continuous ground con- tact. The foot must bear at least 70% of the maximum load. When relieving the foot, the foot must bear at least 15% of the maximum load.

  • Page 19: Standing Mode Function In The 1St Mode

    2.9.2 Standing Mode Function in the 1st Mode INFORMATION Advise your patients of the information in this section. Turning the standing mode function on requires that the 1st mode has been activated (see Section 2.9.1). CAUTION Improper configuration of the standing mode functionality. When trying to configure the standing mode while the patient is standing, unwanted switching can cause the patient to fall.
  • Page 20 2b. Fine tuning of the standing angle (if required) 1 To optimize the angle, very slowly continue to extend the joint (70 – 7°; Fig. 3). 2 The blocked joint can be fully loaded in the flexion direction. INFORMATION Very slow extension (fig. 3): Actively standing up from sitting at this speed would take more than 5 seconds. 2c.

  • Page 21: Optimization Of The Damping Behaviour In The 1St Mode

    2.9.3 Optimization of the Damping Behaviour in the 1st Mode INFORMATION Advise your patients of the information in this section. This functionality is not intended for joint adjustment by the prosthetist, who should adjust the joint by means of the C-Soft adjustment software.

  • Page 22: Pairing Of The Remote Control And Battery Change

    2.10 Pairing of the Remote Control and Battery Change INFORMATION Advise your patients of the information in this section. 2.10.1 Pairing CAUTION Fault while connecting the C-Leg and remote control (pairing). If several joints are present in close prox- imity, this can result in unwanted connection of the remote control with another joint (pairing). This can cause the patient to fall.

  • Page 23: Finishing The Prosthesis

    2.11 Finishing the Prosthesis Upon finalizing all settings, all screws must be fastened and tightened to the proper torque. 1 Optional: Remove the cosmetic foam cover (and also the BionicLink, if present). 2 Secure all screws required for the prosthesis alignment (see Section 2.3) with 636K13 Loctite. 3 Tighten all screws to the proper torque (see Section 2.3) with the 710D4 Torque Wrench.

  • Page 24: Battery Capacity

    Battery capacity During normal operation in the 1st and 2nd modes, the battery capacity is indicated with different vibration signals: Battery capacity Vibration impulse Approx. 1 hour of operation remains 3 × Approx. 30 min. of operation remains 5 × When turning off 10 ×, then turns off Empty battery mode...

  • Page 25: Additional Information

    3 Additional Information 3.1 Service Intervals INFORMATION This component has been tested according to ISO 10328 standard for three million load cycles. Depending on the amputee‘s activity this corresponds to a duration of use of three to five years. The service life can be individually extended in dependence of the intensity of use by making use of regular service inspections (respectively after 24 months) (see C-Leg Service Pass 646D241=*).

  • Page 26: Transportation

    3.4 Transportation Always use the X‑3C100 Shipping Case when transporting your electronic joint system and the Service Joint. 3.5 Guaranty Ottobock offers an extensive guaranty service on the basis of the current C-Leg guaranty concept (see 646D241=* C-Leg Service Card). Please comply with the prescribed service intervals (see Section 3.1 “Service Intervals”). For your own interest, we also recommend obtaining a confirmation from your patients for the provision of instructions and the handing over of the device.
  • Page 27 C-Leg Prosthetic System Ottobock 27...
  • Page 28 The installer of this radio equipment must ensure that the antenna is located or pointed such that it does not emit 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 Patents: European Patent No.

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