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Otto Bock Kenevo 3C60 Instructions For Use Manual
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Otto Bock Kenevo 3C60 Instructions For Use Manual

Otto Bock Kenevo 3C60 Instructions For Use Manual

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Kenevo 3C60*/3C60=ST*
Instructions for use (qualified personnel) .................................................................
3

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Summary of Contents for Otto Bock Kenevo 3C60

  • Page 1 Kenevo 3C60*/3C60=ST* Instructions for use (qualified personnel) ..............
  • Page 2 Kenevo 3C60*/3C60=ST*...
  • Page 3 Only put the product into use in accordance with the information contained in the accompanying documents sup­ plied. According to the manufacturer (Otto Bock Healthcare Products GmbH), the patient is the operator of the product according to the IEC 60601-1 standard 2 Product description 2.1 Design...
  • Page 4 1M10 Adjust the heel height and foot shape): • 1A30 Greissinger plus • SACH Foot with toes and abducted big toe: 1S90 • Terion: 1C10 • SACH foot: 1S101 • 1C30-1 Trias • 1C11 Terion K2 • 1C50 Taleo Kenevo 3C60*/3C60=ST*...
  • Page 5 The MOBIS classification describes the mobility grade and body weight, and makes it easy to identify compatible components. Activity mode A (locked mode) The product is recommended for mobility grade 1 (indoor walker). Approved for a body weight of max. 150 kg. m° Kenevo 3C60*/3C60=ST*...
  • Page 6 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. Kenevo 3C60*/3C60=ST*...
  • Page 7 ► If water, salt water or body and/or wound fluid has penetrated the product and components, the Protective Cover (if any) must be removed immediately. Dry the knee joint and components with a lint-free cloth and allow the components to fully air dry. The prosthesis must be inspected by an authorised Ottobock Service Centre. Kenevo 3C60*/3C60=ST*...
  • Page 8 ► When storing/transporting the product in the immediate vicinity of active implantable systems, ensure that the minimum distances stipulated by the manufacturer of the implant are observed. ► Make sure to observe any operating conditions and safety notices stipulated by the manufacturer of the implant. Kenevo 3C60*/3C60=ST*...
  • Page 9 ► After completing all settings, the set screws in the tube adapter must be secured before they are tightened to the specified torque. ► The screws in the clamp bracket must not be secured but only tightened to the specified torque. Kenevo 3C60*/3C60=ST*...
  • Page 10 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). ► In general, monitor the product for unexpected changes in the damping behaviour when electronic or magnet­ ic devices are in the immediate vicinity. Kenevo 3C60*/3C60=ST*...
  • Page 11 ► 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. Kenevo 3C60*/3C60=ST*...
  • Page 12 Falling due to unexpected product behaviour because of changed damping behaviour. ► The warnings/error signals (see page 40) have to be observed. ► After the safety signal has been emitted, further use of the product is prohibited. ► The product must be inspected by an authorised Ottobock Service Centre. Kenevo 3C60*/3C60=ST*...
  • Page 13 ► Note the instructions of the clinical personnel that indicated the use of the osseointegrated implant system. 5 Scope of Delivery and Accessories 5.1 Scope of delivery • 1 pc. Kenevo 3C60=ST* (with threaded connector) • 1 pc. 4E70-1 inductive charger •...
  • Page 14 → A self-test is performed, and the product should not be moved while this is in progress. The joint is ready for operation only after corresponding feedback (see page 42). 5) Put the prosthesis on. Kenevo 3C60*/3C60=ST*...
  • Page 15 Ensure that possible flexion or adduction of the transfemoral residual limb can be compensated to a permissible extent by an adapter approved by the implant manufacturer in the course of static alignment optimisation. Safe functioning of the knee joint is only guaranteed with biomechanically correct alignment. Kenevo 3C60*/3C60=ST*...
  • Page 16 73 mm. 5) Tighten the two distal tube clamp screws to 7 Nm. INFORMATION A calibration procedure must be performed after each change to the tube adapter, prosthetic foot or knee joint using the adjustment app. Kenevo 3C60*/3C60=ST*...
  • Page 17 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. Kenevo 3C60*/3C60=ST*...
  • Page 18 Instead of using a measuring tool, a large piece of padding material (e.g. 617S3 Pedilin from Ottobock) with a thickness of 3 mm can be used as a distance gauge between the socket and knee joint during the test. Kenevo 3C60*/3C60=ST*...
  • Page 19 Note the different distances from the load line to the alignment reference point (= knee axis) Alignment apparatus Distance from load line to alignment reference point 743L100=* L.A.S.A.R Posture 30 mm 743L500 3D L.A.S.A.R. Posture (3D mode) 20 mm Kenevo 3C60*/3C60=ST*...
  • Page 20 Make adjustments to the distal and proximal set screws of the socket adapter on the prosthetic foot so that the load line (laser line) runs approx. 30 mm in front of the alignment reference point (= knee axis) of the knee joint. Kenevo 3C60*/3C60=ST*...
  • Page 21 Rotation position of the knee joint axis and outward rotation of the prosthetic foot (transversal plane) 7.2 Optional: Installing the foam cover If a foam cover is used with the knee joint, a charging shaft has to be mounted so the charger can be applied. Kenevo 3C60*/3C60=ST*...
  • Page 22 1) Attach the charging shaft receiver to the knee joint using the O-ring. (see fig. 7) 2) Shorten the charging shaft using a suitable tool (see fig. 8) so the length corresponds to the thickness of the foam cover material. Kenevo 3C60*/3C60=ST*...
  • Page 23 3) While sitting down, distribute weight evenly on both legs and push the pelvis in the direction of the backrest. This causes the weight to shift to the heel and the prosthesis to tilt backward, which makes the knee joint switch to the "sitting resistance". Support is therefore provided while sitting down. Kenevo 3C60*/3C60=ST*...
  • Page 24 2) Place the foot of the less affected leg onto the first step. 3) Pull up the other leg. 8.1.8 Walking backwards The knee joint is locked in the flexion direction. Proceed as you would with a rigid knee joint. Kenevo 3C60*/3C60=ST*...
  • Page 25 3) While sitting down, distribute weight evenly on both legs and push the pelvis in the direction of the backrest. This causes the weight to shift to the heel and the prosthesis to tilt backward, which makes the knee joint switch to the "sitting resistance". Support is therefore provided while sitting down. Kenevo 3C60*/3C60=ST*...
  • Page 26 2) Place the foot of the less affected leg onto the first step. 3) Pull up the other leg. 8.2.8 Walking backwards Activity mode B (semi-locked mode) The knee joint is locked in the flexion direction. Proceed as you would with a rigid knee joint. Kenevo 3C60*/3C60=ST*...
  • Page 27 3) Move the buttocks in the direction of the back support and lean the upper body forward. This causes the weight to shift to the heel, making the knee joint switch to the "sitting resistance". Support is therefore provided while sitting down. Kenevo 3C60*/3C60=ST*...
  • Page 28 4) Place the foot of the other leg onto the next step. Walking down stairs one step at a time (step by step) 1) Hold the handrail with one hand. 2) Place the foot of the prosthetic leg on the first step. 3) Pull up the other leg. Kenevo 3C60*/3C60=ST*...
  • Page 29 2) Hold your leg horizontally until the knee joint flexes on its own due to gravity. 3) Put your feet on the pedals and perform pedaling movements within one minute, or turn on the “2. Bicycle ergometer” MyMode using the Cockpit app. Kenevo 3C60*/3C60=ST*...
  • Page 30 With this function, the extended prosthetic knee joint can be locked and also unlocked again by hand. This function can be used in situations where an enhanced feeling of safety from the manual lock is required while walking (e.g. on damp or slippery surfaces). Kenevo 3C60*/3C60=ST*...
  • Page 31 The following feedback signals can be activated only using the adjustment app. They cannot be turned off using the Cockpit app: • Sitting down movement detected (Mode A, B, B+) Supported sitting down/standing up (Mode A, B, B+) • Swing phase angle too high (Mode C) • Kenevo 3C60*/3C60=ST*...
  • Page 32 Short beep signal (low tone) immediately after performing stance phase flexion during the gait cycle. Successful stance release has to take place first. The beep signal is generated at the start of the extension movement if the knee joint was slightly flexed previously. Kenevo 3C60*/3C60=ST*...
  • Page 33 10.1 Establishing the Bluetooth connection The Bluetooth function provides a wireless connection between the component and various devices. Bluetooth must be switched on at the component in order to establish a connection. Bluetooth can be switched on in the following ways: Kenevo 3C60*/3C60=ST*...
  • Page 34 When maintenance is due, this is indicated by feedback after disconnecting the battery charger (see the section "Operating states/error signals", see page 40). The following maintenance intervals must be observed depending on the country/region: Country/region Maintenance interval All countries/regions except: 24 months USA, CAN, RUS Kenevo 3C60*/3C60=ST*...
  • Page 35 14.3 CE conformity Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with applicable European requirements for medical devices. This product meets the requirements of the 2014/53/EU directive.
  • Page 36 -25 °C/-13 °F to +70 °C/+158 °F packaging) Max. 93% relative humidity, non-condensing Operation -10 °C/+14 °F to +40 °C/+104 °F Max. 93% relative humidity, non-condensing Time for warming to the operating temperature after 30 minutes storage between applications, from -25 °C/-13 °F at an ambient temperature of +20 °C/+68 °F Kenevo 3C60*/3C60=ST*...
  • Page 37 Weight 190 g–300 g / 0.42–0.66 lbs Material Aluminium Max. body weight 150 kg Protection rating IP22 Water resistance Not waterproof and not corrosion-resistant Protect the product with clothing in rainy conditions Lifetime 6 years Approved set screws Length 10 mm 12 mm 14 mm 16 mm Kenevo 3C60*/3C60=ST*...
  • Page 38 1 day with average use 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 Kenevo 3C60*/3C60=ST*...
  • Page 39 Protected against dust, protected against part from an electrical point of view only. splashed water There is no direct connection between the Dustproof, protection against temporary sub­ product and the user's body. mersion Complies with the requirements of the Radiocommunications Act (AUS) Kenevo 3C60*/3C60=ST*...
  • Page 40 Mode” MyMode took place. floor. 16.2.2 Warnings/error signals Error during use Beep signal Vibration signal Event Required action – 1x long at interval of Hydraulics overheated Reduce activity. approx. 5 seconds – 3x long Charge level under 25% Charge battery soon. Kenevo 3C60*/3C60=ST*...
  • Page 41 No connection between battery Check whether the charging cable charger and power supply plug is fully engaged on the battery charger. Defective battery charger The battery charger and power supply must be inspected by an authorised Ottobock Service Centre. Kenevo 3C60*/3C60=ST*...
  • Page 42 16.3 Directives and manufacturer’s declaration 16.3.1 Electromagnetic environment This product is designed for operation in the following electromagnetic environments: • Operation in a professional healthcare facility (e.g. hospital, etc.) • Operation in areas of home healthcare (e.g. use at home, use outdoors) Kenevo 3C60*/3C60=ST*...
  • Page 43 Test fre­ Frequency Radio service Modulation Maximum Distance [m] Interference quency band power [W] immunity test [MHz] [MHz] level [V/m] 380 to 390 TETRA 400 Pulse modula­ tion 18 Hz 430 to 470 GMRS 460, FRS 460 ± 5 kHz devi­ ation 1 kHz sine Kenevo 3C60*/3C60=ST*...
  • Page 44 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 Immunity to magnetic fields in close range Test frequency Modulation Interference immunity test level [A/m] 30 kHz 134.2 kHz Pulse modulation 2.1 kHz 13.56 MHz Pulse modulation 50 kHz Kenevo 3C60*/3C60=ST*...
  • Page 45 Kenevo 3C60*/3C60=ST*...
  • Page 46 Kenevo 3C60*/3C60=ST*...
  • Page 47 Kenevo 3C60*/3C60=ST*...
  • Page 48 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 Template-Version: 2023-10-25 · FM483 · SB_210x297...

This manual is also suitable for:

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