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Instructions for Ottobock models including: 3C60 ST Kenevo Knees Microprocessor, 3C60 ST, Kenevo Knees Microprocessor, Knees Microprocessor, Microprocessor
Kenevo | Kenevo | Knees - Microprocessor | Lower Limb Prosthetics | Prosthetics | Ottobock US Shop
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DocumentDocumentKenevo 3C60/3C60=ST Instructions for use (qualified personnel) ................................................................. 3 2 Kenevo 3C60/3C60=ST Table of contents Table of contents 1 2 2.1 2.2 2.3 2.3.1 2.3.2 3 3.1 3.2 3.3 3.4 3.4.1 3.5 4 4.1 4.2 4.3 4.4 4.5 4.6 4.7 4.8 4.9 4.10 4.11 5 5.1 5.2 6 6.1 6.2 6.3 6.3.1 6.3.2 7 7.1 7.1.1 7.1.1.1 7.1.1.2 7.1.1.3 7.1.2 7.1.3 7.1.4 7.1.5 7.1.6 7.1.7 7.1.8 7.1.9 7.2 7.3 8 8.1 Foreword ..............................................................................................................................................................6 Product description ............................................................................................................................................6 Design.................................................................................................................................................6 Function ..............................................................................................................................................6 Combination possibilities .......................................................................................................................7 Limits for combination options with prosthetic feet ....................................................................................8 Combination with an osseointegrated implant system ................................................................................8 Intended use ........................................................................................................................................................8 Indications for use ................................................................................................................................8 Conditions of use..................................................................................................................................8 Indications ...........................................................................................................................................9 Contraindications .................................................................................................................................9 Absolute Contraindications ....................................................................................................................9 Qualification .........................................................................................................................................9 Safety....................................................................................................................................................................9 Explanation of warning symbols ..............................................................................................................9 Structure of the safety instructions ........................................................................................................10 General safety instructions ...................................................................................................................10 Information on the Power Supply/Battery Charging .................................................................................11 Battery charger information ..................................................................................................................12 Information on Alignment/Adjustment ....................................................................................................13 Information on Proximity to Certain Areas ...............................................................................................14 Information on Use ..............................................................................................................................15 Notes on the safety modes ...................................................................................................................16 Instructions for use with an osseointegrated implant system .....................................................................17 Information on the use of a mobile device with the cockpit app .................................................................17 Scope of Delivery and Accessories ................................................................................................................17 Scope of delivery ................................................................................................................................17 Accessories .......................................................................................................................................18 Charging the prosthesis battery......................................................................................................................18 Connecting the power supply and battery charger ..................................................................................18 Connect battery charger to the product..................................................................................................19 Display of the current charge level.........................................................................................................19 Display of battery charge level without additional devices .........................................................................19 Display of the current charge level using the Cockpit app ........................................................................20 Preparing the product for use .........................................................................................................................20 Alignment...........................................................................................................................................20 Settings with the "K-Soft" adjustment software .......................................................................................20 Introduction........................................................................................................................................20 Data transfer between the product and the PC .......................................................................................21 Preparing the product to connect to the adjustment software....................................................................21 Shortening the Tube Adapter................................................................................................................21 Installing the Tube Adapter...................................................................................................................22 Adjusting the torsion moment on the 2R21 AXON tube adapter.................................................................22 Bench alignment in alignment apparatus................................................................................................22 Checking the socket after bench alignment ............................................................................................23 Static alignment optimisation ................................................................................................................24 Dynamic alignment optimisation ............................................................................................................24 Flexion stop........................................................................................................................................25 Optional: Installing the foam cover ........................................................................................................25 Completing the alignment ....................................................................................................................26 Cockpit app........................................................................................................................................................26 System Requirements..........................................................................................................................27 Kenevo 3C60/3C60=ST 3 Table of contents 8.2 8.2.1 8.3 8.3.1 8.4 8.4.1 8.4.2 8.4.3 9 9.1 9.1.1 9.1.2 9.1.3 9.1.4 9.1.5 9.1.6 9.1.7 9.1.8 9.2 9.2.1 9.2.2 9.2.3 9.2.4 9.2.5 9.2.6 9.2.7 9.2.8 9.3 9.3.1 9.3.1.1 9.3.2 9.3.3 9.3.4 9.3.5 9.3.6 9.3.7 9.3.8 9.3.9 9.4 9.5 9.6 9.6.1 9.7 9.8 9.9 10 10.1 10.2 10.3 10.4 11 12 12.1 13 13.1 13.2 Initial connection between cockpit app and prosthesis.............................................................................27 Starting the cockpit app for the first time ................................................................................................27 Control elements for cockpit app ..........................................................................................................28 Cockpit app navigation menu ...............................................................................................................29 Managing components ........................................................................................................................29 Adding component ..............................................................................................................................29 Deleting a component..........................................................................................................................30 Connecting component with multiple mobile devices ...............................................................................30 Use ......................................................................................................................................................................30 Movement pattern in activity mode A (locked mode) ................................................................................30 Standing ............................................................................................................................................30 Walking .............................................................................................................................................31 Sitting down .......................................................................................................................................31 Sitting................................................................................................................................................31 Standing up .......................................................................................................................................31 Walking down stairs ............................................................................................................................32 Walking up stairs ................................................................................................................................32 Walking backwards.............................................................................................................................32 Movement pattern in activity mode B (semi-locked mode) / B+ (semi-locked mode with stance phase flex ion) ...................................................................................................................................................32 Standing ............................................................................................................................................32 Walking .............................................................................................................................................33 Sitting down .......................................................................................................................................33 Sitting................................................................................................................................................33 Standing up .......................................................................................................................................33 Walking down stairs ............................................................................................................................34 Walking up stairs ................................................................................................................................34 Walking backwards.............................................................................................................................34 Movement pattern in activity mode C (yielding mode) ..............................................................................35 Standing ............................................................................................................................................35 Stance function...................................................................................................................................35 Walking .............................................................................................................................................35 Sitting down .......................................................................................................................................35 Sitting................................................................................................................................................36 Standing up .......................................................................................................................................36 Walking down stairs ............................................................................................................................36 Walking up stairs ................................................................................................................................37 Walking down a ramp..........................................................................................................................37 Walking backwards.............................................................................................................................37 Using a bicycle ergometer....................................................................................................................37 Using a wheelchair..............................................................................................................................38 Changing prosthesis settings ...............................................................................................................38 Changing the prosthesis setting using the cockpit app ............................................................................39 Turning Bluetooth on the prosthesis on/off .............................................................................................40 Querying the prosthesis status..............................................................................................................40 Switching off the product .....................................................................................................................41 Additional operating states (modes) ..............................................................................................................41 Empty battery mode.............................................................................................................................41 Mode for charging the prosthesis..........................................................................................................41 Safety mode .......................................................................................................................................41 Overheating mode...............................................................................................................................41 Cleaning .............................................................................................................................................................42 Maintenance ......................................................................................................................................................42 Identification of the product by the Service Center ..................................................................................42 Legal information ..............................................................................................................................................42 Liability ..............................................................................................................................................42 Trademarks ........................................................................................................................................43 4 Kenevo 3C60/3C60=ST Table of contents 13.3 13.4 14 15 15.1 15.2 15.2.1 15.2.2 15.2.3 15.3 15.3.1 CE conformity.....................................................................................................................................43 Local Legal Information .......................................................................................................................43 Technical data ...................................................................................................................................................44 Appendices ........................................................................................................................................................46 Symbols Used ....................................................................................................................................46 Operating states/error signals ..............................................................................................................47 Signals for operating states ..................................................................................................................48 Warnings/error signals ........................................................................................................................48 Status signals .....................................................................................................................................50 Directives and manufacturer's declaration ..............................................................................................50 Electromagnetic environment................................................................................................................50 Kenevo 3C60/3C60=ST 5 Foreword 1 Foreword INFORMATION Date of last update: 2022-12-16 Please read this document carefully before using the product and observe the safety notices. Instruct the user in the safe use of the product. Please contact the manufacturer if you have questions about the product or in case of problems. Report each serious incident related to the product to the manufacturer and to the relevant authority in your country. This is particularly important when there is a decline in the health state. Please keep this document for your records. The product "Kenevo 3C60/3C60=ST" is referred to as the product/prosthesis/knee joint below. These instructions for use provide you with important information on the use, adaptation and handling of the product. 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 60601-1:2005/A1:2012 standard. 2 Product description 2.1 Design The product consists of the following components: 1 2 3 4 5 6 7 8 1. Proximal pyramid adapter 2. LED (blue) as indicator for the Bluetooth connec tion 3. 8° flexion stops (already installed on delivery) 4. Battery and cover caps 5. Hydraulic unit 6. Receiver of the inductive charging unit 7. Distal tube clamp screw 8. Connecting cable for tube adapter 2.2 Function This product features a microprocessor-controlled switch between the stance phase and swing phase and a micro processor-controlled stance phase. The microprocessor uses the measurements of an integrated sensor system as a basis to control a hydraulic unit that influences the damping behaviour of the product. These sensor data are updated and evaluated 100 times per second. As a result, the behaviour of the product is adapted to the current motion situation (gait phase) dynamically and in real time. The product can be individually adapted to the needs of the patient with the K-soft adjustment software. Through the adjustment software, it is possible to choose from three activity modes that make the various functions of the product available. This permits optimum adaptation of the product to the corresponding mobility grade of the patient. The configured activity mode cannot be changed by the patient. The product features the "Bicycle ergometer" MyMode. It has default values configured using the adjustment software and can either be accessed automatically or via the Cockpit app (see page 28). 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 41). 6 Kenevo 3C60/3C60=ST Product description The microprocessor-controlled hydraulic unit offers the following advantages · Stability while standing and walking · Smooth, harmonious, quiet initiation of the swing phase · Automatic recognition of sitting down. Manual unlocking of the joint not required. · Support while sitting down with individually adaptable resistance. This resistance remains constant during the entire process of sitting down. · Support while standing up. The knee joint can be loaded even before reaching full extension. · Approximation of the physiological gait pattern · Adaptation of product characteristics to various surfaces, inclines, gait situations and walking speeds · Manual locking of the knee joint for use of a wheelchair (see page 38). This function makes it possible to lock the knee joint in any extended position while sitting down. This is particularly useful in order to keep the foot from dragging on the ground when the patient is being transported in a wheelchair. Essential performance of the product · Stability in the stance phase · Initiating the swing phase · Adjustable swing phase extension resistance · Adjustable swing phase flexion resistance 2.3 Combination possibilities This product can be combined with the following Ottobock components: Prosthetic hip joints · Modular prosthetic hip joint: 7E7 · Monocentric prosthetic hip joint: 7E9 · Helix 3D prosthetic hip joint: 7E10 Adapters · Double adapter: 4R72=32 · Double adapter: 4R72=45 · Double adapter: 4R72=60 · Double adapter: 4R72=75 · Double adapter: 4R76 · Double adapter: 4R78 · 4R104=60 double adapter, sliding · 4R104=75 double adapter, sliding · Rotation adapter: 4R57, 4R57=* · 4R89 lamination anchor with pyramid adapter · 4R116 lamination anchor with pyramid adapter · 4R41 lamination anchor with pyramid receiver · 4R111 lamination anchor with pyramid receiver · Lamination anchor with pyramid receiver and angled arm: 4R119 · 4R43 lamination anchor with threaded connector · 4R111=N lamination anchor with threaded connect or · 4R40 torsion adapter · 4R118 adapter plate AXON tube adapter · AXON tube adapter: 2R17 · AXON tube adapter: 2R20 · AXON tube adapter with torsion unit: 2R21 Cosmetic cover · Foam cover: 3S26 Prosthetic feet The maximum allowable patient weight depends on the foot size. · Cosmetic light foot: 1G6 · 1D10 Dynamic foot · Pedilan single axis foot, light: 1G9 · Dynamic foot without adapter: 1D10 · Single axis foot without toes: 1H32 or 1H34 · 1D11 Dynamic foot (women) (depending on the heel height) · 1M10 Adjust · Single axis foot with toes: 1H38 or 1H40 (depend · 1A30 Greissinger plus ing on the heel height): · Terion: 1C10 · SACH foot with toes: 1S49, 1S66, or 1S67 · 1C30 Trias (depending on the heel height and foot shape): · Taleo: 1C50 · SACH Foot with toes and abducted big toe: 1S90 · 1C51 Taleo Vertical Shock: · SACH+foot: 1S101, 1S102, 1S103 · Taleo Harmony: 1C52 · 1C11 Terion K2 · Taleo Low Profile: 1C53 Kenevo 3C60/3C60=ST 7 Intended use · 1D35 Dynamic Motion · Kintrol: VS41 1 Note the Ottobock system height · Restore: VS51 · VS2 Promenade1 INFORMATION Calculating the Ottobock system height for the VS2, VS4, VS5 prosthetic feet To calculate the Ottobock system height (e.g. for input in the adjustment software), the build height according to the technical data for the listed prosthetic feet has to be reduced by about 18 mm. Example: The build height of the "VS2" prosthetic foot in size 26 is 124 mm. Therefore, the system height is: 124 mm 18 mm = 106 mm. This is only a reference value. Therefore, measure and verify the distances on the patient before shortening the tube adapter. 2.3.1 Limits for combination options with prosthetic feet CAUTION Failure to observe the tables provided Falling due to breakage of load-bearing components of the prosthetic knee joint. Depending on the patient's body weight, the listed prosthetic feet may only be combined in the respective described foot sizes [cm]. Please contact Ottobock customer service if you would like a combination outside the approved ranges. 1C50 Taleo Body weight Up to 115 kg (253lbs) 116 kg to 125 kg (255 lbs to 275 lbs) Approved foot size [cm] Maximum stiffness Up to 30 7 Not approved 1C53 Taleo Low Profile Body weight Up to 115 kg (253 lbs) 116 kg to 125 kg (255 lbs to 275 lbs) Approved foot size [cm] Up to 30 Up to 29 Maximum stiffness 7 8 2.3.2 Combination with an osseointegrated implant system This product can be connected to a socket or to an osseointegrated, percutaneous implant system. In case of connection to an implant system, verify that the manufacturer of the implant system and the manufactur ers of the corresponding exoprosthetic components/adapters also permit this combination. It must be ensured that all indications/contraindications, the field of application, the conditions of use and all safety instructions are com plied with for the implant system, corresponding exoprosthetic components, corresponding adapters and for the knee joint. 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 44). Please ensure that the qualified personnel applying the product is not only authorised for fitting this knee joint, but also for the connection to the osseointegrated implant system. 3 Intended use 3.1 Indications for use The product is intended exclusively for lower limb exoprosthetic fittings. 3.2 Conditions of use The product was developed for everyday use and should not be used for walking speeds over 3 km/h or unusual activities. These unusual activities include, for example, extreme sports (free climbing, parachuting, paragliding, etc.). Permissible ambient conditions are described in the technical data (see page 44). The prosthesis is intended for use exclusively on the patient for whom the adjustment was made. The manufac turer does not authorise use of the prosthesis on another person. 8 Kenevo 3C60/3C60=ST Safety The MOBIS classification describes the mobility grade and body weight, and makes it easy to identify compatible components. Activity mode A (locked mode) This product is recommended for mobility grade 1 (indoor walker). Approved for a body weight of max. 125kg. m° kg Activity mode B (semi-locked mode) This product is recommended for mobility grade 1 (indoor walker) and mobility grade 2 (restric ted outdoor walker). Approved for a body weight of max. 125 kg. m° kg Activity mode C (yielding mode) This product is recommended for mobility grade 2 (restricted outdoor walker). Approved for a body weight of max. 125 kg. m° kg 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 or a transfemoral amputation · The patient must fulfil the physical and mental requirements for perceiving visual/acoustic signals and/or mech anical vibrations. 3.4 Contraindications 3.4.1 Absolute Contraindications · Body weight over 125 kg 3.5 Qualification 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. 4 Safety 4.1 Explanation of warning symbols WARNING CAUTION NOTICE Warning regarding possible serious risks of accident or injury. Warning regarding possible risks of accident or injury. Warning regarding possible technical damage. Kenevo 3C60/3C60=ST 9 Safety 4.2 Structure of the safety instructions WARNING The heading describes the source and/or the type of hazard The introduction describes the consequences in case of failure to observe the safety instructions. Consequences are presented as follows if more than one consequence is possible: > 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. 4.3 General safety instructions WARNING Use of damaged power supply unit, adapter plug or battery charger Risk of electric shock due to contact with exposed, live components. Do not open the power supply unit, adapter plug or battery charger. Do not expose the power supply unit, adapter plug or battery charger to extreme loading conditions. Immediately replace damaged power supply units, adapter plugs or battery chargers. CAUTION Failure to observe warning/error signals Falling due to unexpected product behaviour because of changed damping behaviour. The warnings/error signals (see page 48) and corresponding change in damping settings must be observed. CAUTION Independent manipulation of the product and the components Falling due to breakage of load-bearing components or malfunction of the product. Manipulations to the product other than the tasks described in these instructions for use are not permitted. The battery may only be handled by authorised, qualified Ottobock personnel (no replacement by the user). The product and any damaged components may only be opened and repaired by authorised, qualified Ottobock personnel. CAUTION Mechanical stress on the product > Falling due to unexpected product behaviour as the result of a malfunction. > 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. CAUTION Use of the product when battery charge level is too low Falling due to unexpected behaviour of the prosthesis because of changed damping behaviour. Check the current charge level before use and charge the prosthesis if required. Note that the operating time of the product may be reduced at low ambient temperatures or due to ageing of the battery. CAUTION Risk of pinching in the joint flexion area Injuries due to pinching of body parts. Ensure that fingers/body parts or soft tissue of the residual limb are not in this area when bending the joint. 10 Kenevo 3C60/3C60=ST Safety CAUTION Penetration of dirt and humidity into the product > Falling due to unexpected product behaviour as the result of a malfunction. > Falling due to breakage of load-bearing components. Ensure that solid particles, foreign objects and liquids (such as body and/or wound fluids) are not allowed to penetrate into the product. Do not expose the product to splashed water. Thick clothing should be worn over the product as a minimum in rainy conditions. 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. CAUTION Mechanical stress during transport > Falling due to unexpected product behaviour as a result of a malfunction. > Falling due to breakage of load-bearing components. > Skin irritation due to defects on the hydraulic unit with leakage of liquid. Only use the transport packaging for transportation. CAUTION Signs of wear and tear on the product components Falling due to damage or malfunction of the product. Regular service inspections (maintenance) are mandatory in the interest of patient safety and in order to main tain operating reliability and protect the warranty. CAUTION Use of unapproved accessories > 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 17) and "Accessories" (see page 18). 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). 4.4 Information on the Power Supply/Battery Charging CAUTION Charging the prosthesis without taking it off Falling due to unexpected behaviour of the prosthesis because of changed damping behaviour. Inform the patient that wearing the prosthesis is not permitted during the entire charging process. CAUTION Charging the product with damaged power supply unit/charger/charger cable Falling due to unexpected behaviour of the product caused by insufficient charging. Check the power supply unit, charger and charger cable for damage before use. Replace any damaged power supply unit, charger or charger cable. Kenevo 3C60/3C60=ST 11 Safety NOTICE Use of incorrect power supply unit/battery charger Damage to product due to incorrect voltage, current or polarity. Use only power supply units/battery chargers approved for this product by Ottobock (see instructions for use and catalogues). 4.5 Battery charger information WARNING Storing/transporting the product near active implanted systems Interference with active implantable systems (e.g. pacemaker, defibrillator, etc.) due to the product's magnetic field. 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. NOTICE Improper care of the housing Damage to the casing through the use of acetone, white spirit or similar solvents. Only clean the housing with a damp cloth and mild soap (e.g. 453H10=1 Ottobock DermaClean). NOTICE Penetration of dirt and humidity into the product Lack of proper charging functionality due to malfunction. Ensure that neither solid particles nor liquids can penetrate into the product. NOTICE Mechanical stress on the power supply/battery charger Lack of proper charging functionality due to malfunction. Do not subject the power supply/battery charger to mechanical vibrations or impacts. Check the power supply/battery charger for visible damage before each use. NOTICE Operating the power supply unit/charger outside of the permissible temperature range Lack of proper charging functionality due to malfunction. Only use the power supply unit/charger for charging within the allowable temperature range. The section "Technical data" contains information on the allowable temperature range (see page 44). 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. NOTICE Contact of the battery charger with magnetic data storage devices Wiping of the data storage device. Do not place the battery charger on credit cards, diskettes, audio or video cassettes. 12 Kenevo 3C60/3C60=ST Safety 4.6 Information on Alignment/Adjustment CAUTION Use of unsuitable prosthesis components Falling due to unexpected behaviour of the product or breakage of load-bearing components. Use the product only in combination with components listed in the section "Combination possibilities" (see page 7). CAUTION Improper assembly of the screw connections Falling due to breakage or loosening of the screw connections. Clean the threads before every installation. Apply the specified tightening torque values for installation (see the section "Technical data" see page 44). Observe the instructions for securing the screw connections and the use of the correct length. CAUTION Incorrectly secured screws Falling due to breakage of load-bearing components caused by screw connections coming loose. 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. CAUTION Incorrect alignment or assembly Falling due to damage to the prosthesis components. Observe the alignment and assembly instructions. CAUTION Errors during prosthesis alignment Falling due to breakage of load-bearing components. At maximum flexion (reached under full load!), it is essential to maintain a minimum distance of 3 mm (1/8") between the hydraulic unit and the socket. At maximum flexion and insofar as contact with the frame of the knee joint cannot be avoided (in case of volu minous residual limbs), the socket must lie flat against the frame. Soft cushioning on the socket will assist in keeping the socket flat. 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. Kenevo 3C60/3C60=ST 13 Safety CAUTION Operator errors when adjusting settings using the adjustment software Falling due to unexpected prosthesis behaviour. Do not charge the prosthesis battery during the adjustment process since the prosthesis is not functional while the battery is being charged. During the adjustment process, the prosthesis must not remain unattended when connected to the adjustment software while being worn by the patient. Observe the maximum range of the Bluetooth connection and note that obstacles may limit this range. During the data transfer (PC to prosthesis), the prosthesis wearer should sit or stand still, and the BionicLink PC must not be removed from the computer. If you want to make only temporary changes to the settings while connected to the adjustment software, you must reverse these changes before disconnecting the adjustment software. You must also ensure the patient does not leave the range of the Bluetooth connection if settings have been changed temporarily. Inform the patient immediately if the data connection is accidentally interrupted during the adjustment pro cess. The connection to the prosthesis must always be disconnected after adjustments have been completed. Successful participation in an Ottobock product training course is mandatory prior to initial use. Additional product training courses may be required to qualify for software updates. The correct input of the foot size, prosthesis dimensions, body weight and calibration are important criteria for achieving a quality fitting. If the values are too high, the prosthesis may not switch to the swing phase. If the values are too low, the prosthesis may trigger the swing phase at the wrong time. If the patient uses walking aids (e.g., crutches or walking canes) during the adjustment process, you will need to readjust the settings when the patient no longer requires these aids. Use the online help function integrated into the software. Do not disclose your personal access data. CAUTION Error during optimisation of damping behaviour Falling due to unexpected behaviour of the product. Note that the patient must stand very securely during this procedure to ensure safety. 4.7 Information on Proximity to Certain Areas CAUTION Insufficient distance to HF communication devices (e.g. mobile phones, Bluetooth devices, WiFi devices) Falling due to unexpected behaviour of the product caused by interference with internal data communication. Therefore, keeping a minimum distance of 30 cm to HF communication devices is recommended. CAUTION Operating the product in very close proximity to other electronic devices Falling due to unexpected behaviour of the product caused by interference with internal data communication. 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. 14 Kenevo 3C60/3C60=ST Safety CAUTION Proximity to sources of strong magnetic or electrical interference (e.g. theft prevention systems, metal detectors) Falling due to unexpected behaviour of the product caused by interference with internal data communication. 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). In general, monitor the product for unexpected changes in the damping behaviour when electronic or magnet ic devices are in the immediate vicinity. CAUTION Entering a room or area with strong magnetic fields (e.g. magnetic resonance tomographs, MRT (MRI) equipment...) > Falling due to unexpected restriction of the product's range of motion caused by metallic objects adhering to the magnetised components. > Irreparable damage to the product due to the effect of strong magnetic fields. Make sure that the patient takes off the product before entering the room or area and stores the product out side this room or area. Damage to the product caused by exposure to strong magnetic fields cannot be repaired. CAUTION Remaining in areas outside the allowable temperature range Falling due to malfunction or the breakage of load-bearing product components. Ensure that the patient is not in areas outside the permissible temperature range (see page 44) during trial fit ting. 4.8 Information on Use CAUTION Walking up stairs Falling due to foot being placed incorrectly on stair as a result of changed damping behaviour. Inform the patient that the handrail always has to be used when walking up stairs, and that most of the sole of the foot has to be set onto the stair surface. Particular caution is required when carrying children up the stairs. CAUTION Walking down stairs Falling due to foot being placed incorrectly on stair as a result of changed damping behaviour. Inform the patient that the handrail always has to be used when walking down stairs, and that the patient has to roll over the edge of the step with the middle of the shoe. The warnings and error signals have to be observed (see page 48). 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. Kenevo 3C60/3C60=ST 15 Safety CAUTION Overheating of the hydraulic unit due to uninterrupted, increased activity (e.g. extended walking down hill) > Falling due to unexpected behaviour of the product because of switching into overheating mode. > Burns due to touching overheated components. Be sure to pay attention when pulsating vibration signals start. They indicate the risk of overheating. As soon as these pulsating vibration signals begin, the activity level has to be reduced so the hydraulic unit can cool down. Full activity may be resumed after the pulsating vibration signals stop. 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. CAUTION Overloading due to unusual activities > Falling due to unexpected product behaviour as the result of a malfunction. > Falling due to breakage of load-bearing components. > Skin irritation due to defects on the hydraulic unit with leakage of liquid. The product was developed for everyday use and should not be used for walking speeds over 3 km/h or unusual activities. These unusual activities include, for example, extreme sports (free climbing, parachuting, paragliding, etc.). Careful handling of the product and its components not only increases their service life but, above all, ensures the patient's personal safety! If the product and its components have been subjected to extreme loads (e.g. due to a fall, etc.), then the product must be inspected for damage immediately. If necessary, forward the product to an authorised Ottobock Service Centre. CAUTION Incorrect switching between "Bicycle ergometer" MyMode/"Basic mode" Falling due to unexpected product behaviour because of changed damping behaviour. Ensure that the patient is sitting on the bicycle ergometer during all switching processes. Inform the patient that the signals that indicate switching to the MyMode and to basic mode have to be observed. Switching back to basic mode is mandatory once the activities in the MyMode have been completed. Correct the switching or use the Cockpit app if necessary. Inform the patient that verifying whether the chosen mode corresponds to the desired movement type is always required before taking the first step/making the first movement. 4.9 Notes on the safety modes CAUTION Using the product in safety mode Falling due to unexpected product behaviour because of changed damping behaviour. The warnings/error signals (see page 48) have to be observed. CAUTION 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. 16 Kenevo 3C60/3C60=ST Scope of Delivery and Accessories CAUTION Safety mode cannot be deactivated Falling due to unexpected product behaviour because of changed damping behaviour. If safety mode cannot be deactivated by recharging the battery, a permanent error has occurred. Using the product when it is defective is prohibited. The product must be inspected by an authorised Ottobock Service Centre. CAUTION Safety signal occurs (ongoing vibration) Falling due to unexpected product behaviour because of changed damping behaviour. The warnings/error signals (see page 48) 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. 4.10 Instructions for use with an osseointegrated implant system WARNING High mechanical loads due to normal or unusual situations, such as falling > Overloading of the bone, which can lead to pain, loosening of the implant, necrosis or fracture among other things. > Damage or breakage of the implant system or its components (safety components...). 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. 4.11 Information on the use of a mobile device with the cockpit app CAUTION Improper use of the mobile device Falling due to altered damping behaviour as a result of unexpected switching into a MyMode. Use the instructions for use (user) to instruct the patient on the proper handling of the mobile device with the Cockpit app. CAUTION Independently applied changes or modifications made to the mobile device Falling due to altered damping behaviour as a result of unexpected switching to a MyMode. Do not make any independent changes to the hardware of the mobile device on which the app is installed. Do not make any independent changes to the software/firmware of the mobile device that are not included in the update function of the software/firmware. CAUTION Improper mode switching with the mobile device Falling due to unexpected product behaviour because of changed damping behaviour. Ensure that the patient stands securely during all switching processes. Inform the patient that the changed damping characteristics have to be verified after switching, and feedback from the acoustic signal emitter and the mobile device display must be observed. Switching back to basic mode is mandatory once the activities in the MyMode have been completed. 5 Scope of Delivery and Accessories 5.1 Scope of delivery · 1 pc. Kenevo 3C60=ST (with threaded connector) · 1 pc. AXON 2R17 tube adapter or or · 1 pc. 2R20 AXON tube adapter or · 1 pc. Kenevo 3C60 (with pyramid connector) 1 pc. 2R21 AXON tube adapter with torsion Kenevo 3C60/3C60=ST 17 Charging the prosthesis battery · 1 pc. 757L16-4 power supply · 1 pc. 4E70-1 inductive charger · 1 pc. Instructions for use (qualified personnel) · 1 pc. Instructions for use (user) · 1 pc. prosthesis passport · 2 pc. 4H107 8° flexion stop (already installed on delivery) · 2 pc. 4H108 16° flexion stop · 1 pc. cosmetic case for battery charger and power supply · "4X441-V2=* Cockpit" app for download from the website: https://www.ottobock.com/cockpitapp The Cockpit app has to be installed in version 2.5.0 or higher for use with this knee joint. 5.2 Accessories The following components are not included in the scope of delivery and may be ordered separately: · Kenevo Protective Cover 4X840 · 3S26 cosmetic foam cover · "4X445=V1.6 K-Soft" or higher adjustment soft · 4X633 Kenevo foam cover toolset ware, update by Internet download. Note the system requirements! · 4X634 Kenevo foam cover charging set 6 Charging the prosthesis battery The following points must be observed when charging the battery: · Use the 757L16-4 power supply and 4E70-1 battery charger to charge the battery. · The full surface of the inductive charger must be in contact with the receiver of the charging unit. This must be verified, particularly when fabricating a cosmetic foam cover. Prior to application, check the contact surfaces for dirt and ensure that no objects are adhering to them. · The capacity of a fully charged battery is sufficient for one full day. · We recommend charging the product once a day when used by the patient on a daily basis. · For the maximum operating time with one battery charge, disconnecting the battery charger from the product only immediately before using the product is recommended. · The battery should be charged for at least 3 hours prior to initial use. · Note the permissible temperature range for charging the battery (see page 44). · The battery may discharge while the product is not being used. · The tube adapter must be connected before disconnecting the battery charger, otherwise an error message will result (see page 48). INFORMATION Depending on the distance between the battery charger and the receiver on the knee joint, the battery charger can warm up considerably during the charging process. This is not a malfunction. 6.1 Connecting the power supply and battery charger 1 2 3 1) Slide the country-specific plug adapter onto the power supply until it locks into place (see fig. 1). 2) Connect the round, three-pin plug of the power supply to the receptacle on the inductive battery charger so that the plug locks into place. (see fig. 2) INFORMATION: Ensure correct polarity (guide lug). Do not use force when connecting the cable plug to the battery charger. 3) Plug the power supply into the outlet (see fig. 3). The green LED on the back of the power supply lights up. If the green LED on the power supply does not light up, there is an error (see page 48). 18 Kenevo 3C60/3C60=ST Charging the prosthesis battery 6.2 Connect battery charger to the product INFORMATION Do not move the knee joint while it conducts the self-test immediately after disconnecting the charger. Otherwise, an error may occur; if this happens, the problem can be corrected by reconnecting and then disconnecting the charger. 1) Remove the prosthesis. 2) Connect the inductive charger to the receiver of the charging unit on the back of the product. Make sure the contact surfaces are clean, with no objects adhering to them. The charger is held in place by a magnet. A correct connection between the battery charger and the product is indic ated by feedback (see page 50). 3) The charging process starts. Once the product battery is fully charged, the LED on the battery charger lights up green. 4) After the charging process is complete, remove the inductive charger from the receiver and hold the product still. 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 50). 5) Put the prosthesis on. INFORMATION To make the operating time of the prosthesis as long as possible, the charger should not be removed until imme diately before the prosthesis is used. Indication of the charging process: Battery charger Battery is charging. The on time of the LED indicates the current charge level. The on time of the LED gets longer as the charge level increases. It only flashes briefly at the start of the charging process and stays on continuously at the end of the charging process. Battery is fully charged, or the temperature has exceeded/fallen below the permissible range for the knee joint during charging. Check current charge level (see page 19). 6.3 Display of the current charge level 6.3.1 Display of battery charge level without additional devices INFORMATION The charge level cannot be displayed during the charging process, e.g. by turning the prosthesis over. The product is in charging mode. 1) Turn the prosthesis 180° (the sole of the foot has to face up). 2) Hold still for 2 seconds and wait for beeps. Kenevo 3C60/3C60=ST 19 Preparing the product for use Beep signal 5x short 4x short 3x short 2x short 1x short 1x short Vibration signal 3x long 5x long Battery charge level more than 80% 65% to 80% 50% to 65% 35% to 50% 20% to 35% less than 20% 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: 1. 38% Charge level of battery for currently connected component 7 Preparing the product for use 7.1 Alignment The following alignment guidelines contain descriptions for connecting the knee joint to a prosthetic socket. In principle, the alignment of the prosthesis is independent of the type of connection for the knee joint. In case of a connection to an osseointegrated, percutaneous implant system, a socket is not used during bench alignment in the alignment apparatus. In this case, the central proximal point on the prosthetic socket corresponds to the trochanter of the thigh bone (see illustration in the section "Bench alignment in the alignment apparatus" see page 22). 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. 7.1.1 Settings with the "K-Soft" adjustment software 7.1.1.1 Introduction The "K-Soft" adjustment software makes it possible to optimise the product settings for a patient. The adjustment software provides step-by-step guidance through the adjustment process. After the settings are configured, the data for them can be saved and printed for documentation. These data can be retrieved if required and imported into the product. Please consult the integrated online help in the adjustment software for further information. INFORMATION The 4X445 K-Soft adjustment software, version 1.6 or higher, is required for correct alignment. If K-Soft is on hand in version 1.0 or higher, it can be updated. Note the system requirements! Updating the K-Soft adjustment software 1) Click "Help > About" in the menu bar of the Data Station when you are connected to the Internet. The window opens with the versions of the previously installed programs and the manufacturer's address. 2) Click the "Check for updates" button in this window. A search for updates of previously installed software products and components is performed via the Inter net. 3) If updates are available, click "Download" in the column on the right in order to download and save the update. 4) Extract the "ZIP file" and execute it. 20 Kenevo 3C60/3C60=ST Preparing the product for use INFORMATION Cybersecurity Keep your operating system up to date and always install any available security updates. Protect your computer from unauthorised access (e.g., by using virus scans, password protection etc.). Do not use unsecured networks. Please contact the manufacturer if you suspect cybersecurity problems. 7.1.1.2 Data transfer between the product and the PC Product settings using the adjustment software can only be made via Bluetooth data transfer. For this purpose, a 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. 7.1.1.3 Preparing the product to connect to the adjustment software If the product does not emit any signals when querying the charge level (see page 19), the battery is drained or the product is switched off. Switching on the product 1) Connect the power supply with battery charger to the wall socket. 2) Connect the battery charger to the product. 3) Wait for feedback signals. 4) Disconnect the battery charger from the product. After feedback signals are emitted (self test), the product is switched on. Switching on Bluetooth Upon delivery, the Bluetooth function of the prosthesis is switched off. When the Bluetooth function is switched off, it is only turned on for 2 minutes after connecting/disconnecting the battery charger and is then turned off again automatically. When a connection with the PC is active (the symbol is lit up), the Bluetooth function is not switched off automatically. 7.1.2 Shortening the Tube Adapter CAUTION Incorrect processing of tube Falling due to damage to the tube. Do not clamp the tube into a vice. For shortening the tube, use only a tube cutter. CAUTION Damage to the cable while shortening the tube adapter Falling due to unexpected product behaviour as the result of switching into safety mode. When shortening the tube adapter, make sure the cable does not get damaged. 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. 3) Store the tube adapter cable in the tube adapter. If this is not possible, the cable must be protected against damage. 4) Use a file (cut 2 (medium), e.g. 715H1=2 recommended) to file the cut edge smooth. Be careful of the tube adapter cable. NOTICE! When filing or deburring, make sure that no metal shavings can get into the plug of the tube adapter cable. 5) Chamfer the outside with a file. 6) Smooth the inside and outside of the cut edge with sandpaper (recommended grit 120). Kenevo 3C60/3C60=ST 21 Preparing the product for use 7.1.3 Installing the Tube Adapter CAUTION Improper assembly of the screw connections Falling due to breakage or loosening of the screw connections. Clean the threads before every installation. Apply the specified tightening torque values for installation (see the section "Technical data" see page 44). Observe the instructions for securing the screw connections and the use of the correct length. 1) Install the prosthetic foot on the tube adapter and tighten the set screws on the tube adapterto a torque of 15 Nm. INFORMATION: Replace any set screws that are protruding or recessed too much with suitable ones. For approved set screws, see the section "Technical data" (see page 44). INFORMATION: The printed scale on the tube adapter must face forward. 2) Connect the cable of the tube adapter to the cable of the knee joint. 3) Push the protruding cable loop back into the tube adapter. If the tube adapter has been shortened to the min imum length, the plug must be inserted in the cavity. The cable loop must then be stored carefully. 4) Insert the tube adapter about 60 mm into the knee joint (for the exact value, consult the configuration assistant in the adjustment software). INFORMATION: Corrections in the insertion depth between 40 mm and 73 mm are permissible (slide in 13 mm and pull out 20 mm). 5) Turn the foot outwards slightly and slightly tighten the distal tube clamp screw(approx. 4 Nm). INFORMATION: After alignment optimisation, this screw must be tightened to a torque of 7 Nm. INFORMATION A calibration procedure must be performed after each change to the tube adapter, prosthetic foot or knee joint using the adjustment software. INFORMATION Disconnect tube adapter without error message If the tube adapter is disconnected while the knee joint is operational, an error message is output. To prevent this error message, the knee joint must be switched off before the tube adapter is disconnected (see page 41). 7.1.4 Adjusting the torsion moment on the 2R21 AXON tube adapter CAUTION Incorrect setting of the torsion moment in the torsion unit Falling due to unexpected behaviour of the product. The marking on the Allen head screw may not be turned as far as the red area or beyond the red area. The torsion moment can be adjusted with the Allen head screw in the centre of the adapter. Increasing the torsion moment: Turn the mark in the centre of the torsion unit clockwise. Decreasing the torsion moment: Turn the mark in the centre of the torsion unit counterclockwise. INFORMATION If the patient notices a sudden change in the torsion moment, check whether the mark of the Allen head screw is still within the setting range. Correct the setting if this is not the case. 7.1.5 Bench alignment in alignment apparatus INFORMATION The alignment recommendations must be observed in order for the prosthesis to function correctly. 22 Kenevo 3C60/3C60=ST Preparing the product for use INFORMATION The patient's gait pattern shall change as he/she becomes accustomed to the prosthesis. Therefore it is recommended to complete the entire adjustment procedure again about two weeks after the initial fitting. A correct bench alignment (e.g. using the 743A200 PROS.A. Assembly alignment apparatus) ensures that the user can benefit from all the advantages of the product. If the L.A.S.A.R. Assembly alignment apparatus (743L200) is available, it can be used as well. 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 marked during plaster cast taking and trial fitting of the check socket) will facilitate correct positioning of the lamin ation anchor or socket adapter. Position the middle of the foot (MF) approx. 30 mm/1.18 inch anterior to the alignment reference line (A). This applies to all foot components that are recommended for use with the product, independently of the previous alignment specifications in the instructions for use of those feet! Noting the alignment recommendation of the foot component, add 5 mm to the effective heel height (shoe heel height sole thickness in the forefoot area) and set the outward rotation of the foot. Place the alignment reference point (=knee axis) approx. 0-5 mm/0-0.19 inch anterior to the alignment reference line. Take into account the knee-ground distance and outward rotation of the knee (the adapter insert provides for a rotation of approx. 5°). Recommended sagittal positioning of the alignment refer ence point: 20 mm/0.79 inch above the medial tibial plateau. Connect the foot and knee joint using a tube adapter. To do so, tilt the joint in the correct position and set the required tube length. Mark the lateral centre of the socket with a centred, proximal dot and a distal dot. Mark a line through both points from the edge to the end of the socket. Now position the socket such that the alignment reference line passes through the proximal centre mark. Adjust the socket flexion to 3° 5°, but take the individual situ ation (e.g. hip joint contractures) and the ischial tuberosity-toground distance into account. Connect the socket and modular knee using adapters. 7.1.6 Checking the socket after bench alignment After bench alignment, verify that at maximum extension and maximum flexion the distance from the socket to the knee joint is not less than the minimum. A collision of the socket with the hydraulics or frame can cause damage to the knee joint. Verification at maximum flexion If the distance between the socket and hydraulics is not sufficient, the hydraulics may be damaged. Check the distance as follows: 1) Bring the knee joint with socket to maximum flexion. 2) Check the available distance between the hydraulics and socket. It must be at least 3 mm. INFORMATION: If the distance is less, a flexion stop has to be installed or an existing flexion stop replaced with a larger one. For information on the flexion stop, see the next section. Kenevo 3C60/3C60=ST 23 Preparing the product for use Verification at maximum extension If the distance between the socket or system components such as a rotation adapter and the electronics is not sufficient, these may be damaged. Be sure to follow the system component instructions for use. Check the distance as follows: 1) Bring the knee joint and socket to maximum extension. 2) Check the available distance between the electronics/top edge of the installed Protective Cover and the socket or system components such as a rotation adapter. It must be at least 5 mm. INFORMATION If a protective cover is subsequently installed, the available distance between the electronics and socket without the protective cover has to be at least 10 mm. Installing the protective cover reduces this distance by 5 mm. 7.1.7 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: To determine the load line, have the patient (with shoes) stand on the force measuring plate with the prosthetic side and on the height compensation plate with the other leg. The prosthesis side must be sufficiently loaded (>35% body weight). Note the weight display on the L.A.S.A.R. Posture. Optimise the alignment solely by changing the plantar flexion. Only make adjustments to the distal and proximal setscrews of the socket adapter on the prosthetic foot, so that the load line (laser line) runs approx. 30 mm/1.18 inch in front of the align ment reference point (= knee axis) for the knee joint. 7.1.8 Dynamic alignment optimisation After adjusting the product with the adjustment software, perform dynamic optimisation during trial walking. Often, the following aspects have to be observed and adapted, if necessary: · Socket flexion position by verifying step length symmetry (sagittal plane) · Adduction position of the socket and M-L positioning of the socket adapter (frontal plane) · Rotation position of the knee joint axis and outward rotation of the prosthetic foot (transversal plane) 24 Kenevo 3C60/3C60=ST Preparing the product for use 7.1.9 Flexion stop The knee joint comes fitted with a flexion stop upon delivery. This reduces the maximum flexion angle by 8°, thus preventing the socket from coming into contact with the hydraulic unit. To limit the flexion angle, the knee joint can be equipped with the following flexion stops: · 4H107 flexion stop (already installed): reduction of the maximum flexion angle by 8° · 4H108 flexion stop (in scope of delivery): reduction of the maximum flexion angle by 16° The flexion stop can be removed to increase the flexion angle. In this case, it must be ensured that the socket and the hydraulic unit do not collide (see page 23). Removing the flexion stop 1) Use an appropriate screwdriver to loosen the screws on both flexion stops (to the left and right of the piston rod). 2) Remove both flexion stops from the joint together with the screws. INFORMATION: Do not insert screws without flexion stops! 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 0.6 Nm with the 710D1 torque wrench. 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. Preparing the foam cover 4 5 6 > The required tools and components are included in the 4X633 Kenevo foam cover toolset: centring plate, centring rod, hole cutter, 65X3 O-ring 1) Attach the centring plate to the knee joint over the receiver of the charging unit using the O-ring. (see fig. 4) 2) Pull on the foam cover. 3) Feel the area of the centring bore through the foam and mark the area. 4) Make an opening for the threaded rod in the marked area. 5) Insert the centring rod through the opening and screw it into the centring plate to the stop. (see fig. 5) NOTICE! The two nuts are used to limit the screw-in depth and protect the charging receiver and must not be removed. 6) Apply the hole cutter and rotate it clockwise to cut a hole. (see fig. 6) 7) Unscrew the centring rod. 8) Remove the foam cover. Kenevo 3C60/3C60=ST 25 Cockpit app 9) Take the centring plate off the knee joint. Installing the charging shaft 7 8 9 > The required tools and components are included in the 4X634 Kenevo foam cover charging set: char ging shaft receiver, charging shaft, cover for charging shaft, 65X3 O-ring 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. 3) Deburr the cut edge. 4) Clip the charging shaft cover to the charging shaft. 5) Pull on the foam cover. 6) Insert the charging shaft and push it in until it engages in the charging shaft receiver. (see fig. 9) 7.3 Completing the alignment Upon finalising all settings, all screw connections must be tightened to the proper tightening torque (see page 44). INFORMATION A calibration procedure must be performed after each change to the tube adapter, prosthetic foot or knee joint using the adjustment software. CAUTION Incorrectly secured screws Falling due to breakage of load-bearing components caused by screw connections coming loose. 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. 8 Cockpit app The patient can change the behaviour of the product to a certain extent with the Cockpit app. In addition, information about the product (step counter, charge level, etc.) can be retrieved. The adjustment software can be used to trace the change at the patient's next appointment. 26 Kenevo 3C60/3C60=ST Cockpit app Information on the Cockpit app · The Cockpit app can be downloaded free of charge from the respective online store. For more information, please visit the following website: https://www.ottobock.com/cockpitapp. To download the Cockpit app, the QR code on the supplied Bluetooth PIN card can also be read with the mobile device (requirement: QR code reader and camera). · 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. · The serial number of the component to be connected has to be registered with Ottobock the first time it is con nected. If the registration is not accepted, use of the Cockpit app for this component will be limited. · Bluetooth on the prosthesis must be turned on in order to use the Cockpit app. If Bluetooth is switched off, it can be turned on by turning the prosthesis upside-down (sole of the foot must point up) or by connecting/disconnecting the battery charger. Bluetooth is then turned on for approx. 2 minutes. 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 40). · Keep the mobile app up to date at all times. · Please contact the manufacturer if you suspect cybersecurity problems. 8.1 System Requirements See the information in the Apple App Store or Google Play Store regarding compatibility with mobile devices and versions. 8.2 Initial connection between cockpit app and prosthesis The following points need to be observed before establishing the connection: · Bluetooth of the component must be switched on (see page 40). · Bluetooth on the mobile device must be switched on. · The mobile device must not be in "flight mode" (offline mode), otherwise all wireless connections are turned off. · The mobile device must be connected to the Internet. · The serial number and Bluetooth PIN of the component being connected must be known. They are found on the enclosed 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. 8.2.1 Starting the cockpit app for the first time 1) Tap the symbol of the Cockpit app ( ). The end user license agreement (EULA) is displayed. 2) Accept the end user license agreement (EULA) by tapping the Accept button. If the end user license agree ment (EULA) is not accepted, the Cockpit app cannot be used. The welcome screen appears. 3) Hold the prosthesis with the sole of the foot facing up, or connect and then disconnect the battery charger, in order to activate recognition (visibility) of the Bluetooth connection for 2 minutes. 4) Tap the Add component button. The Connection Wizard opens and guides you through the process of establishing a connection. 5) Follow the subsequent instructions on the screen. 6) After the Bluetooth PIN is entered, a connection to the component is established. While the connection is being established, 3 beep signals sound and the symbol appears. The 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. INFORMATION After the initial connection to the component has been established successfully, the app will connect automatically each time it is started. No further steps are required. Kenevo 3C60/3C60=ST 27 Cockpit app INFORMATION After activating the "visibility" of the component (holding the component with the sole of the foot facing up, or con necting and then disconnecting the battery charger), the component can be recognised by another device (e.g. smartphone) within 2 minutes. If registration or establishing the connection takes too long, the process of establishing a connection is cancelled. In this case, hold the component with the sole of the foot facing up again, or connect and then disconnect the battery charger. 8.3 Control elements for cockpit app INFORMATION The illustrations in these instructions for use are only examples and may deviate from the respective mobile device being used and the version. 1 Product 2 1. Basic Mode change 3 Bicycle ergometer 4 5 7 6 8 100% 1. Basic Mode 1. Access the navigation menu (see page 29) 2. Product The component name can only be changed with the adjustment soft ware. 3. If connections to more than one component have been saved, you can switch between the saved components by tapping the change option (see page 29). 4. If the "Intuitive bicycle ergometer function" function has been enabled in the adjustment software and in the Cockpit app, this function can be activated manually by tapping the "Bicycle ergometer" MyMode and confirming with "OK". See the section "Using a bicycle ergometer" (see page 37) for further information. 5. Currently selected mode 6. Charge level of the component. Component battery fully charged Component battery empty Component battery charging The current charge level is also displayed in %. 7. Display of and designation for the currently selected mode (e.g. 1. Basic Mode) 8. 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. 28 Kenevo 3C60/3C60=ST Cockpit app 8.3.1 Cockpit app navigation menu Tap the symbol in the menus to display the navigation menu. Additional settings for the connected component can be configured in this menu. Product Name of the connected component MyModes Return to the main menu to switch MyModes Functions Call up additional functions of the component (e.g. turn off Bluetooth) (see page 40) Settings Change settings of the currently selected mode (see page 38) Status Query status of the connected component (Querying the prosthesis status) Manage components Add or delete components (see page 29) Imprint/Info Display information/legal notices for the cockpit app 8.4 Managing components Connections with up to four different components can be stored in the app. However, a component can only be connected to one mobile device at a time. INFORMATION Before establishing the connection, observe the points in the section "Initial connection between Cockpit app and component" (see page 27). 8.4.1 Adding component 1) Tap the symbol in the main menu. The navigation menu opens. 2) In the navigation menu, tap the "Manage components" item. 3) Hold the prosthesis with the sole of the foot facing up, or connect and then disconnect the battery charger, in order to activate recognition (visibility) of the Bluetooth connection for 2 minutes. 4) Tap the "+" button. The Connection Wizard opens and guides you through the process of establishing a connection. 5) Follow the subsequent instructions on the screen. 6) After the Bluetooth PIN is entered, a connection to the component is established. While the connection is being established, three beep signals sound and the symbol appears. The 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. The main menu will then appear with the name of the connected component. INFORMATION 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") Kenevo 3C60/3C60=ST 29 Use INFORMATION After activating the "visibility" of the component (holding the component with the sole of the foot facing up, or con necting and then disconnecting the battery charger), the component can be recognised by another device (e.g. smartphone) within 2 minutes. If registration or establishing the connection takes too long, the process of establishing a connection is cancelled. In this case, hold the component with the sole of the foot facing up again, or connect and then disconnect the battery charger. 8.4.2 Deleting a component 1) Tap the symbol in the main menu. The navigation menu opens. 2) In the navigation menu, tap the entry "Manage components". 3) Tap the "Edit" button. 4) Tap the symbol under the component you want to delete. The component is deleted. 8.4.3 Connecting component with multiple mobile devices The connection for a component can be stored on more than one mobile device. However, only one mobile device can be connected to the component at one time. If there is an existing connection between the component and a different mobile device, the following information appears while the connection is being established with the current mobile device: Connect to this component? Component was connected to another device. Establish connection? Tap the "OK" button. The connection to the last connected mobile device is broken off and established with the current mobile device. Cancel OK 9 Use INFORMATION Knee joint movement noise When using exoprosthetic knee joints, servomotor, hydraulic, pneumatic or brake load dependent control func tions can cause movement noise. This kind of noise is normal and unavoidable. It generally does not indicate any problems. If movement noise increases noticeably during the lifecycle of the knee joint, the knee joint should be inspected by an authorised Ottobock Service Centre immediately. 9.1 Movement pattern in activity mode A (locked mode) 9.1.1 Standing The knee joint is locked in the flexion direction. Therefore, proceed as you would with a rigid knee joint. INFORMATION: In response to a sitting movement, the joint switches to high flexion resistance. 30 Kenevo 3C60/3C60=ST 9.1.2 Walking Use Initial attempts at walking with the prosthesis always require the instruction of trained, quali fied personnel. The knee joint is locked in the flexion direction. Therefore, proceed as you would with a rigid knee joint. 9.1.3 Sitting down The prosthesis makes it possible to sit down without unlocking it manually. The adjustable flexion resistance of the hydraulic unit provides support while sitting down. We recommend that the user supports themselves with their hands while sitting down, e.g.: · Support on the armrests of the chair · Support on the handles of a walker · Use of forearm crutches · Use of a cane 1) Stand 5 to 10 cm in front of the edge of the chair. While standing up, the edge of the chair should not yet touch the hollow of the knee nor press against the lower leg. 2) Place both feet side by side at the same level. 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. 9.1.4 Sitting If the user is in a sitting position, i.e. the thigh is close to horizontal and there is no load on the leg, the knee joint switches to a low resistance in both the flexion and extension direc tion. If the load on the prosthesis was not sufficient while sitting down, the leg is extended during this process. Due to the nearly horizontal position of the lower leg, the flexion resistance is reduced automatically and the lower leg lowers on its own. If the sitting function is enabled in the adjustment software and activated via the Cockpit app (see page 39), the resistance in the flexion direction is reduced as well. 9.1.5 Standing up Notwithstanding low damping while sitting, the prosthesis supports standing up. Damping is increased after rising from the seat. From an angle of approx. 45°, the knee joint identifies a "standing up process" which results in what is called "pre-locking" in the flexion direction. This function makes it possible to stand up with pauses in between. The joint fully supports weight during these pauses. If standing up is aborted, the "sitting down" function is activated again. The joint is locked after fully standing up. 1) Place the feet at the same level. 2) Lean the upper body forward. 3) Put the hands on armrests, if available. 4) Stand up with support from the hands, while keeping weight evenly distributed over feet. Kenevo 3C60/3C60=ST 31 Use 9.1.6 Walking down stairs The knee joint is locked in the flexion direction. 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. INFORMATION: Walking down stairs step-over-step is not possible in this activity mode. 9.1.7 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 less affected leg onto the first step. 3) Pull up the other leg. 9.1.8 Walking backwards The knee joint is locked in the flexion direction. Proceed as you would with a rigid knee joint. 9.2 Movement pattern in activity mode B (semi-locked mode) / B+ (semi-locked mode with stance phase flexion) 9.2.1 Standing Activity mode B (semi-locked mode) The knee joint is locked in the flexion direction. INFORMATION:The joint responds to a sitting movement by switching to high flexion resistance. 32 Kenevo 3C60/3C60=ST Use Activity mode B+ (semi-locked mode with stance phase flexion) The knee joint is locked starting at stance phase flexion of up to 10°. INFORMATION:The joint responds to a sitting movement by switching to high flexion resistance. 9.2.2 Walking Initial attempts at walking with the prosthesis always require the instruction of trained, quali fied personnel. The hydraulics stabilise the knee joint in the stance phase and release the knee joint in the swing phase so that the leg can swing forward freely. In order to safely switch to the swing phase, the prosthesis has to be partially unloaded from the lunge position with a simultaneous forward movement. If desired, stance phase flexion of up to 10° can be permitted for this mode in the adjustment software (setting only available in activity mode B). 9.2.3 Sitting down The prosthesis makes it possible to sit down without unlocking it manually. The adjustable flexion resistance of the hydraulic unit provides support while sitting down. We recommend that the user supports themselves with their hands while sitting down, e.g.: · Support on the armrests of the chair · Support on the handles of a walker · Use of forearm crutches · Use of a cane 1) Stand 5 to 10 cm in front of the edge of the chair. While standing up, the edge of the chair should not yet touch the hollow of the knee nor press against the lower leg. 2) Place both feet side by side at the same level. 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. 9.2.4 Sitting If the user is in a sitting position, i.e. the thigh is close to horizontal and there is no load on the leg, the knee joint switches to a low resistance in both the flexion and extension direc tion. If the load on the prosthesis was not sufficient while sitting down, the leg is extended during this process. Due to the nearly horizontal position of the lower leg, the flexion resistance is reduced automatically and the lower leg lowers on its own. If the sitting function is enabled in the adjustment software and activated via the Cockpit app (see page 39), the resistance in the flexion direction is reduced as well. 9.2.5 Standing up The prosthesis supports standing up despite the low flexion resistance while sitting. The resistance is increased after rising from the seat. From an angle of approx. 45°, the knee joint identifies a "standing up process" which results in what is called "pre-locking" in the flexion direction. This function makes it possible to stand up with pauses in between. The joint fully supports weight during these pauses. If the process of standing up is discontinued, the "sitting down" function is activated again. The joint is locked after fully standing up. Kenevo 3C60/3C60=ST 33 Use 1) Place the feet at the same level. 2) Lean the upper body forward. 3) Place the hands on arm supports, if available. 4) Stand up with support from the hands while distributing weight evenly between the feet. 9.2.6 Walking down stairs The knee joint is locked in the flexion direction. 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. INFORMATION: Walking down stairs step-over-step is not possible in this activity mode. 9.2.7 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 less affected leg onto the first step. 3) Pull up the other leg. 9.2.8 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. Activity mode B+ (semi-locked mode with stance phase flexion) The knee joint is locked starting at stance phase flexion of up to 10°. Proceed as you would with a rigid knee joint. 34 Kenevo 3C60/3C60=ST Use 9.3 Movement pattern in activity mode C (yielding mode) 9.3.1 Standing Knee control through high hydraulic resistance and static alignment. A stance function can be enabled using the adjustment software. Please see the following section for further information on the stance function. 9.3.1.1 Stance function INFORMATION To use this function, it needs to be enabled in the adjustment app. It also has to be activated using the Cockpit app (see page 39). The intuitive stance automatically recognises any situation that puts strain on the prosthesis in the flexion direction but where flexion is not permitted. Examples of this include standing on uneven or sloping surfaces. The knee joint is always locked in the flexion direction when the prosthetic leg is not fully extended, is under some amount of load and is at rest. When the load is taken off the leg or forward or backward rollover occurs, the level of resistance is immediately reduced to stance phase resistance again. 9.3.2 Walking Initial attempts at walking with the prosthesis always require the instruction of trained, quali fied personnel. The hydraulics stabilise the knee joint with high flexion resistance in the stance phase and release the knee joint in the swing phase so that the leg can swing forward freely. In order to safely switch to the swing phase, the prosthesis has to be partially unloaded from the lunge position with a simultaneous forward movement. 9.3.3 Sitting down The prosthesis provides high flexion resistance while sitting down. This ensures that the knees bend evenly, thereby supporting the contralateral side. We recommend that the user supports themselves with their hands while sitting down, e.g.: · Support on the armrests of the chair · Support on the handles of a walker · Use of forearm crutches · Use of a cane 1) Place both feet side by side at the same level. 2) While sitting down, weight should be distributed evenly between both legs and the arm supports used where applicable. 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 35 Use 9.3.4 Sitting If the user is in a sitting position, i.e. the thigh is close to horizontal and there is no load on the leg, the knee joint switches to a low resistance in both the flexion and extension direc tion. If the load on the prosthesis was not sufficient while sitting down, the leg is extended during this process. Due to the nearly horizontal position of the lower leg, the flexion resistance is reduced automatically and the lower leg lowers on its own. If the sitting function is enabled in the adjustment software and activated via the Cockpit app (see page 39), the resistance in the flexion direction is reduced as well. 9.3.5 Standing up Notwithstanding low damping while sitting, the prosthesis supports standing up. Damping is increased after rising from the seat. After standing up entirely, high damping (corresponding to the value of the "stance phase damping" parameter) is set automatically. INFORMATION If the intuitive stance function was deactivated in the adjustment software, there is no support while standing up. 1) Place the feet at the same level. 2) Lean the upper body forward. 3) Put the hands on armrests, if available. 4) Stand up with support from the hands. while keeping weight evenly distributed on the feet. 9.3.6 Walking down stairs The joint makes it possible to walk down stairs step-over-step or one at a time. Walking down stairs step-over-step Walking down stairs step-over-step must be practised and executed consciously. The knee joint can switch correctly and permit a controlled rollover only by stepping down properly with the sole of the foot. The motion must be carried out in a continuous pattern in order to allow the motion sequence to proceed in a fluid manner. 1) Hold the handrail with one hand. 2) Position the leg with the prosthesis on the step so that the foot projects halfway over the edge of the step. This is the only way to ensure a secure rollover. 3) Roll the foot over the edge of the step. This flexes the prosthesis slowly and evenly under high flexion resistance. 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. 36 Kenevo 3C60/3C60=ST Use 9.3.7 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 less affected leg onto the first step. 3) Pull up the other leg. 9.3.8 Walking down a ramp Under increased flexion resistance, permit controlled flexion of the knee joint which lowers the body's centre of gravity. The swing phase is not triggered even though the knee joint is flexed. 9.3.9 Walking backwards While walking backwards, the hydraulics keep the knee joint stable with high flexion resist ance. 9.4 Using a bicycle ergometer The "Bicycle ergometer" MyMode allows a bicycle ergometer to be used without exiting the currently selected activity mode. Note the prerequisites for switching and the differences for activation in the respective activ ity modes. Prerequisites for activating the "Bicycle ergometer" MyMode · A bicycle ergometer is required. Switching is not possible for recumbent bicycles or so-called pedal trainers. · The bicycle ergometer must have a freewheel. · The user must be in the sitting position. · The sitting position must not be too high, otherwise the knee is extended during the pedaling movement, end ing the MyMode. · The sitting position must not be too low. Note the permissible flexion range of the knee joint. · The feet have to be positioned on the pedals. · Pedaling movements must be possible. Activating the "Bicycle ergometer" MyMode (activity mode A, B, B+) 1) Sit on the bicycle ergometer with the leg extended. 2) Hold the leg horizontally until the knee joint flexes on its own due to gravity. Kenevo 3C60/3C60=ST 37 Use 3) Put the feet on the pedals and perform pedaling movements within one minute, or activate the "2.Bicycle ergometer" MyMode using the Cockpit app. After a few pedaling movements, these are recognised by the knee joint and a short beep and vibration sig nal is produced. If this signal is not produced, the time limit for positioning the feet on the pedals (one minute) was exceeded or the prerequisites for activating this MyMode are not met. The short beep and vibration signal is produced periodically at intervals during the pedaling movement until the resistances in the flexion and extension direction have been reduced to the extent that the knee joint moves freely. This MyMode (2. Bicycle ergometer)is shown in the overview in the Cockpit app. Activating the "Bicycle ergometer" MyMode (activity mode C) 1) Sit on the bicycle ergometer. 2) Put the feet on the pedals. 3) Perform pedaling movements or activate the "2.Bicycle ergometer" MyMode using the Cockpit app. After a few pedaling movements, these are recognised by the knee joint and a short beep and vibration sig nal is produced. If this signal is not produced, the prerequisites for activating this MyMode were not met. The short beep and vibration signal is produced periodically at intervals during the pedaling movement until the resistances in the flexion and extension direction have been reduced to the extent that the knee joint moves freely. This MyMode (2. Bicycle ergometer) is shown in the overview in the Cockpit app. Deactivating the "Bicycle ergometer" MyMode (activity mode A, B, B+, C) From the sitting position, either extend the knee or take the foot off the pedal and put it on the floor. The foot has to be ahead of the knee joint when it is set on the floor. This is recognised by the knee joint and a long beep and vibration signal is produced. If this signal is not produced, either repeat the process or switch to the "1. Basic Mode" MyMode using the Cockpit app. This MyMode is shown in the overview in the Cockpit app. 9.5 Using a wheelchair When sitting in a wheelchair, the joint can be locked in the flexed position for short distances. The lock can be engaged in any position from an angle of 45°. This prevents the foot from dragging on the floor. To use this func tion, it must be enabled in the adjustment software. Locking the joint Raise the foot and hold it still in the desired position. The lock engages automatically. INFORMATION: At full extension, the lock engages in a slightly flexed position so the foot can be lifted in order to release the lock. Disengaging the lock The lock can be disengaged in the following ways: · Extended pressure on the ball of the foot. · Extended pressure on the toes (from the top of the foot). · Lift the foot (extend the knee) and allow the foot to lower again. INFORMATION Turning the "Wheelchair function" function off/on using the Cockpit app If the "Locking function for wheelchair" function was turned on in the adjustment software, the "Wheelchair function" function can be turned off and back on again using the Cockpit app. 9.6 Changing prosthesis 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. INFORMATION Bluetooth on the prosthesis has to be switched on to change the prosthesis settings (see page 40). 38 Kenevo 3C60/3C60=ST Use Information for changing the prosthesis settings · Before changing settings, always check the main menu of the Cockpit app to make sure the correct component has been selected. Otherwise parameters could be changed for the wrong component. · It is not possible to change prosthesis settings nor to switch to a different mode while the prosthesis battery is being charged. Only the status of the prosthesis can be called up. Instead of the symbol, the symbol appears in the bottom row of the screen in the cockpit app. · The O&P professional's setting is in the middle of the scale. After making adjustments, this setting can be restored by tapping the "Standard" button in the Cockpit app. · Prosthesis settings should be optimised using the adjustment software. The Cockpit app is not intended for use by the O&P professional to set up the prosthesis. The patient can use the app to change the behaviour of the prosthesis to a certain extent during everyday use (e.g. while becoming accustomed to the prosthesis). The O&P professional can use the adjustment software to track these changes at the patient's next appointment. 9.6.1 Changing the prosthesis setting using the cockpit app 1) Once the component is connected and in the desired mode, tap the icon in the main menu. The navigation menu opens. 2) Tap the "Settings" menu option. A list appears with the parameters for the currently selected mode. 3) Change the setting of the desired parameter by tapping the "<", ">" icons. INFORMATION: The O&P professional's setting is marked and, after the setting has been changed, can be restored by tapping the "Standard" button. The following parameters can be modified: INFORMATION Number of parameters depending on selected activity mode Some parameters are not available depending on the currently selected activity mode. Parameter Adjustment soft Cockpit app ware range adjustment range Meaning Resistance 120 to 180 +/- 10 of the con Flexion resistance while sitting down, in the figured value stance phase, while walking on ramps and stairs. Intuitive stance function¹ 0/Off deactiva 0/Off deactiva Information about this function is provided in ted ted the section "Stance function" (see see 1/On activated 1/On activated page 35) Intuitive bicycle 0/Off deactiva 0/Off deactiva Information about this function is provided in ergometer function¹ ted ted the section "Using a bicycle ergometer" 1/On activated 1/On activated (see see page 37) Kenevo 3C60/3C60=ST 39 Use Parameter Adjustment soft Cockpit app ware range adjustment range Meaning Wheelchair function¹ 0/Off deactiva 0/Off deactiva Information about this function is provided in ted ted the section "Using a wheelchair" (see see 1/On activated 1/On activated page 38) Sitting function¹ 0/Off deactiva 0/Off deactiva When the function is activated, the resistance ted ted in the flexion direction while sitting is reduced 1/On activated 1/On activated in addition to the reduction of resistance in the extension direction. Donning function 0/Off deactiva 0/Off deactiva If the knee joint is not loaded for a few ted ted seconds after disconnecting the charger, the 1/On activated 1/On activated prosthesis can be flexed. Flexion makes put ting on the prosthesis easier. Ending knee flexion or loading the prosthesis immediately reactivates the configured operating state. This function can be activated in mode A, B or B+. ¹ To use these functions in the Cockpit app, they need to be enabled or turned on in the adjustment app. 9.7 Turning Bluetooth on the prosthesis on/off INFORMATION Bluetooth on the prosthesis must be turned on in order to use the Cockpit app. If Bluetooth is switched off, it can be turned on by turning the prosthesis upside-down (function only available in basic mode) or by connecting/disconnecting the battery charger. Bluetooth is then turned on for approx. 2 minutes. 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 40). Switching off Bluetooth 1) With the component connected, tap the icon in the main menu of the Cockpit app. The navigation menu opens. 2) Tap the "Functions" option in the navigation menu. 3) Tap the "Deactivate Bluetooth" option. 4) Follow the on-screen instructions. Switching on Bluetooth 1) Turn the component over or connect/disconnect the battery charger. Bluetooth is switched on for approx. 2 minutes. The Cockpit app must be started within this time to estab lish a connection to the component. 2) Follow the on-screen instructions. If Bluetooth is switched on, the icon appears on the screen. 9.8 Querying the prosthesis status 1) With the component connected, tap the icon in the main menu of the Cockpit app. 2) Tap the "Status" option in the navigation menu. Menu option Trip: 1747 Step: 1747 Batt.: 68 Description Possible actions Daily step counter Reset the counter by tapping the "Reset" button. Total step counter Information only Current prosthesis charge level, as a Information only percentage 40 Kenevo 3C60/3C60=ST Additional operating states (modes) 9.9 Switching off the product CAUTION Using the product while switched off Falling due to unexpected behaviour of the product because of changed damping behaviour. Before using the product, switch it on by connecting the power supply and battery charger. In certain cases, e.g. for storage or transportation, the prosthesis can be purposely switched off. It can only be switched on by connecting to a live outlet, a power supply and a battery charger. Switching off The product can be switched off by briefly connecting/disconnecting the battery charger 3 times. 1) Connect the battery charger to the product and wait for the beep signal. 2) Disconnect the battery charger immediately after the beep signal sounds. 3) Reconnect the battery charger immediately after another beep signal sounds. 4) Carry out this process (steps 2 and 3) a total of three times. After the charger has been disconnected for the third time, a descending sequence of five beeps is emitted and the product is then switched off. INFORMATION If too much time passes between connecting and disconnecting (e.g. a vibration signal is already emitted), the process of connecting and disconnecting 3 times has to be repeated. Switching on 1) Connect the power supply with battery charger to the outlet. 2) Connect the battery charger to the product. The correct connection of the battery charger to the product is indicated by feedback (see page 50). 10 Additional operating states (modes) The product automatically switches to special operating states (modes) when an error occurs, in case of an empty battery or while charging. Functioning of the prosthesis is limited due to its altered damping behaviour. 10.1 Empty battery mode The joint emits beeps and vibration signals when the charge level is 15% or less (see page 48). Then the damping settings are set to high flexion resistance and low extension resistance, and the product is switched off. Before switching to empty battery mode, warning signals are emitted at a battery charge level below 35% (see page 48). You can switch back to basic mode from empty battery mode by charging the product. 10.2 Mode for charging the prosthesis The product is non-functional during charging. To switch to basic mode, the battery charger for the product must be disconnected after the battery 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). Safety mode remains in effect until the error has been rectified. A setting for high flexion resistance and low extension resistance is applied in safety mode. This makes limited walking possible for the user even though the product is not active. The switch to safety mode is indicated by beeps and vibration signals immediately prior to switching (see page 48). Safety mode can be disabled by connecting and disconnecting the battery charger. If the product switches into safety mode again, this means a permanent error exists. The product must be inspected by an authorised Ottobock Service Centre. 10.4 Overheating 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. The hydraulic unit cannot overheat in activity mode A or B. Therefore, no overheating mode is triggered in these two activity modes. Overheating mode is indicated by a long vibration every 5 seconds. Kenevo 3C60/3C60=ST 41 Cleaning The following functions are deactivated in overheating mode in activity mode C: · Joint lock for use of a wheelchair (see page 38) · Battery level indication (see page 19) 11 Cleaning 1) Clean the product with a damp cloth (fresh water) when needed. 2) Dry the product with a lint-free cloth and allow it to air dry fully. 12 Maintenance Regular maintenance (service inspections) is mandatory in the interest of patient 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 disconnecting the battery charger (see the section "Operating states/error signals", see page 47). The following maintenance intervals must be observed depending on the country/region: Country/region Maintenance interval All countries/regions except: USA, CAN, RUS 24 months USA, CAN, RUS As needed*, No later than every 36 months *As needed: the maintenance interval depends on the patient's activity level. For patients with a normal to low activity level who take up to 1,800 steps per day, the expected maintenance interval is 3 years. For highly active patients who take more than 1,800 steps per day, the expected maintenance interval is 2 years. Additional services such as repairs may be provided in the course of maintenance. These additional services may be provided free of charge or can be billable according to an advance cost estimate, depending on the extent and validity of the warranty. The following components must always be sent in for maintenance and repairs: The product with installed tube adapter, battery charger and power supply unit. The shipping container for the loaner unit you receive must be reused for sending back the components requiring inspection. 12.1 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). User setting The settings already configured using the adjustment software were not changed. CAUTION Use of the prosthesis with incorrect setting data Falling due to unexpected prosthesis behaviour caused by triggering the swing phase at the wrong time. The prosthesis settings (parameters) have to be checked using the corresponding adjustment software and changed as needed. 13 Legal information 13.1 Liability 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. 42 Kenevo 3C60/3C60=ST Legal information 13.2 Trademarks All product names mentioned in this document are subject without restriction to the respective applicable trade mark laws and are the property of the respective owners. All brands, trade names or company names may be registered trademarks and are the property of the respective owners. Should trademarks used in this document fail to be explicitly identified as such, this does not justify the conclusion that the denotation in question is free of third-party rights. 13.3 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. The product meets the requirements of the RoHS Directive 2011/65/EU on the restriction of the use of certain haz ardous substances in electrical and electronic devices. The full text of the regulations and requirements is available at the following Internet address: http://www.ottobock.com/conformity 13.4 Local Legal Information Legal information that applies exclusively to specific countries is written in the official language of the respective country of use in this chapter. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: 1) This device may not cause harmful interference, and 2) This device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harm ful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: --Reorient or relocate the receiving antenna. --Increase the separation between the equipment and receiver. --Connect the equipment into an outlet on a circuit different from that to which the receiver is connected. --Consult the dealer or an experienced radio/ TV technician for help. Any changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. Caution: Exposure to Radio Frequency Radiation. This device must not be co-located or operating in conjunction with any other antenna or transmitter. This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada's licence-exempt RSS(s).. Operation is subject to the following two conditions: (1) This device may not cause interference. (2) This device must accept any interference, including interference that may cause undesired operation of the device. L'émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d'Innovation, Sci ences et Développement économique Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes: (1) L'appareil ne doit pas produire de brouillage; (2) L'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en com promettre le fonctionnement. Caution: Exposure to Radio Frequency Radiation. 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. Kenevo 3C60/3C60=ST 43 Technical data 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. 14 Technical data Ambient conditions Transport in original packaging -25 °C/-13 °F to +70 °C/+158 °F Storage in the original packaging (3 months) -20 °C/-4 °F to +40 °C/+104 °F Max. 93% relative humidity, non-condensing Long-term storage in the original packaging -20 °C/-4 °F to +20 °C/+68 °F (>3 months) Max. 93% relative humidity, non-condensing Transport and storage between applications (without -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 Time for cooling to the operating temperature after stor 30 minutes age between applications, from +70 °C/+158 °F at an ambient temperature of +20 °C/+68 °F Charging the battery +5 °C/+41 °F to +40 °C/+104 °F Product Reference number 3C60*/3C60=ST* Mobility grade according to MOBIS (activity mode A) 1 Mobility grade according to MOBIS (activity mode B) 1 and 2 Mobility grade according to MOBIS (activity mode C) 2 Maximum body weight 125 kg Protection rating IP22 Water resistance Not waterproof and not corrosion-resistant Protect the product with clothing in rainy conditions Proximal system height up to alignment reference point 5 mm 3C60* (pyramid connector) Proximal system height up to alignment reference point 23 mm 3C60=ST (threaded connector) Minimum distal system height with tube adapter 270 mm Maximum distal system height with tube adapter 490 mm Range of Bluetooth connection to PC Max. 10 m Maximum possible flexion angle 124° Maximum insertion depth of the tube adapter in the knee 73 mm joint Weight of the prosthesis without tube adapter and Pro Approx. 910 g tective Cover Frequency range of the receiver of the inductive char 110 kHz to 205 kHz ging unit Information on the product's ruleset and firmware ver Accessible via the Cockpit app navigation menu and the sion menu item "Imprint/Info" Expected lifetime given compliance with the prescribed 6 years maintenance intervals Test procedure ISO10328-P6-125 kg/3 million load cycles Data communication Wireless technology Bluetooth 5.0 (Bluetooth Low Energy) 44 Kenevo 3C60/3C60=ST Technical data Data communication Distance range Frequency range Modulation Data rate (over the air) Maximum output power (EIRP): Approx. 10 m / 32.8 ft 2,402 MHz to 2,480 MHz GFSK Up to 2 Mbps +4 dBm (~2.5 mW) Tube adapter Reference number Weight Material Max. body weight Protection rating Water resistance Lifetime Approved set screws Length Reference number Maximum tightening torque 2R17 190 g300 g / 0.420.66 lbs Aluminium 125 kg IP22 Not waterproof and not corrosion-resistant Protect the product with clothing in rainy conditions 6 years 10 mm 506G3= M8x10 12 mm 14 mm 506G3= M8x12V 506G3= M8x14 15 Nm 16 mm 506G3= M8x16 Tube adapter Reference number Weight Material Max. body weight Protection rating Water resistance Lifetime Approved set screws Length Reference number 2R20 2R21 (with torsion unit) 190300 g/0.420.66 lbs 435545 g/0.961.20 lbs Aluminium 150 kg 125 kg IP67 IP54 Weatherproof but not cor Weatherproof but not cor rosion-resistant rosion-resistant Not designed for pro Protected against splashed longed underwater use or water from all directions, prolonged submersion but not designed for under water use 6 years 6 years 10 mm 506G3= M8x10 12 mm 506G3= M8x12 14 mm 506G3= M8x14 16 mm 506G3= M8x16 Prosthesis battery Battery type Li-Ion Charging cycles (charging and discharging cycles) 300 after which at least 80% of the original battery capacity remains available Charging time until battery is fully charged 68 hours Product behaviour during the charging process The product is non-functional Operating time of prosthesis with fully charged battery 1 day with average use Power supply unit Reference number Type Storage and transport in original packaging Storage and transport without packaging 757L16-4 FW8001M/12 -40 °C/-40 °F to +70 °C/+158 °F 10% to 95% relative humidity, non-condensing -40 °C/-40 °F to +70 °C/+158 °F 10% to 95% relative humidity, non-condensing Kenevo 3C60/3C60=ST 45 Appendices Power supply unit Operation Input voltage Mains frequency Output voltage Battery charger Reference number Storage and transport in original packaging Storage and transport without packaging Operation Protection rating Input voltage Lifetime Wireless technology Frequency range Modulation Maximum output power (EIRP) Cockpit app Reference number Version Supported operating system Website for download 0 °C/+32 °F to +50 °C/+122 °F Max. 95% relative humidity Air pressure: 70106 kPa (up to 3,000 m without pres sure equalisation) 100 V~ to 240 V~ 50 Hz to 60 Hz 12 V 4E70-1 -25 °C/-13 °F to +70 °C/+158 °F -25 °C/-13 °F to +70 °C/+158 °F Max. 93% relative humidity, non-condensing 0 °C/+32 °F to +40 °C/+104 °F Max. 93% relative humidity, non-condensing IP40 12 V 6 years Qi 110 kHz to 205 kHz ASK, load modulation -18.00 dBµA/m @ 10 m 4X441-V2=* Cockpit Version 2.5.0 or higher See the information in the respective online store (e.g. Apple App Store, Google Play Store, etc.) regarding compatibility with mobile devices and versions. https://www.ottobock.com/cockpitapp 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. Clamp bracket on 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. or Flexion stop 0.6 Nm/5 lbf. In. 15 Appendices 15.1 Symbols Used Manufacturer Type BF applied part 46 Kenevo 3C60/3C60=ST Please note the instructions for use Appendices Compliance with the requirements according to "FCC Part 15" (USA) Compliance with the requirements under the "Radiocommunications Act" (AUS) Non-ionising radiation In some jurisdictions it is not permissible to dispose of these products with unsorted household waste. Disposal that is not in accordance with the regulations of your country may have a detri mental impact on health and the environment. Please observe the instructions of your national authority pertaining to return and collection. The product's Bluetooth wireless module can establish a connection to mobile devices with the following operating systems: iOS (iPhone, iPad, iPod...) and Android Declaration of conformity according to the applicable European directives Serial number (YYYY WW NNN) YYYY year of manufacture WW week of manufacture NNN sequential number Lot number (PPPP YYYY WW) PPPP plant YYYY year of manufacture WW week of manufacture Medical device Article number Protect from moisture Protection against penetration of solid foreign objects with a diameter greater than 1 mm, no pro tection against water Protection against penetration of solid foreign objects with a diameter greater than 12.5 mm, pro tection against water dripping diagonally up to 15°. Caution, hot surface 15.2 Operating states/error signals The prosthesis indicates operating states and error messages through beeps and vibration signals. Kenevo 3C60/3C60=ST 47 Appendices 15.2.1 Signals for operating states Battery charger connected/disconnected Beep signal 1 x short Vibration signal 1 x short 3 x short 1 x before beep signal Event Battery charger connected or Battery charger already disconnected prior to start of charging mode Charging mode started (3 sec. after connecting the bat tery charger) Battery charger disconnected after start of charging mode Mode switching Beep signal Vibration sig Additional action performed nal Event 1x short 1x short Mode switching using the Cockpit Mode switching is performed using the app Cockpit app. 1x short 1x short User has sat on the bicycle After a few pedaling movements, this ergometer and commenced pedal was recognised and switching to the ing movement "2.Bicycle ergometer" MyMode took place. Short at periodic Short at period The pedaling movements were The flexion and extension resistances intervals ic intervals continued. are reduced to the extent that the knee joint moves freely. 1x long 1x long The prosthetic leg was extended Placing the foot on the floor was recog or the foot was placed on the nised and switching back to the "1. floor. Basic Mode" MyMode took place. 15.2.2 Warnings/error signals Error during use Beep signal 10x long Vibration signal 1x long at interval of approx. 5 seconds 3x long 5x long 10x long Event Hydraulics overheated Required action Reduce activity. Charge level under 25% Charge battery soon. Charge level under 15% Charge battery immediately; the product will be switched off after the next warning sig nal. Charge level 0% Charge the battery. After the beep and vibra tion signals, the product switches to empty battery mode and then switches off. 48 Kenevo 3C60/3C60=ST Appendices Beep signal 30x long Vibration signal Event Required action 1x long, 1x short repeated Severe error/indication Walking possible with restric every 3 seconds of safety mode activa tions. Please note the possible tion change in flexion/extension For example, a sensor is resistance. not ready for operation, Attempt to reset this error by AXON tube adapter not connecting/disconnecting the connected or valve drive battery charger. The battery failure charger must remain connec Possibly no switching into ted for at least 5 seconds safety mode. before it is disconnected. If the error persists, use of the product is prohibited. The product must be inspected by an authorised Ottobock Ser vice Center. Continuous Total failure Attempt to reset this error by Electronic control no connecting/disconnecting the longer possible. Safety battery charger. mode active or undeter If the error persists, use of the mined valve state. product is prohibited. The Unknown product beha product must be inspected by viour. an authorised Ottobock Ser vice Center. Error while charging the product LED on LED on power battery supply charger Battery charger connected to product No Yes Error Resolution Country-specific plug adapter not Check whether the country-specific fully engaged on power supply plug adapter is fully engaged on the power supply. Outlet not functioning Check outlet with another electrical device. Defective power supply The battery charger and power supply must be inspected by an authorised Ottobock Service Centre. Distance between battery charger The distance between the battery and receiver on knee joint too great charger and the receiver on the knee joint must not exceed 1 mm 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 49 Appendices LED on power supply LED on Battery charger battery connected to charger product The LED Yes turns off or changes colour at irregular intervals Error Resolution Temperature of the battery charger The distance between the battery too high charger and the receiver on the knee joint must not exceed 1 mm. If this distance is too great during the charging process, the magnetic surface of the battery charger can heat up and interrupt the charging process. Take the battery charger off the knee joint, disconnect it from the power supply and let it cool down. If the error recurs, the battery char ger must be inspected by an autho rised Ottobock Service Centre. Beep signal Error Resolution 4 x short at intervals of Charging the battery outside the allowable Check whether the specified ambient con approx. 20 sec. (continu temperature range ditions for charging the battery are met ously) (see page 44). 15.2.3 Status signals Battery charger connected LED on LED on power sup battery ply charger Event Power supply and battery charger operational Battery charger disconnected Beep sig nal 1 x short 3 x short Vibration signal 1 x short Event Self-test completed successfully. Product is operational. Maintenance note Conduct the self-test again by connecting/disconnecting the battery charger. If the beep signal is repeated, maintenance of the product should be carried out by an authorised Ottobock Service Centre. The product can be used without restrictions. However, vibration signals may not be generated. Battery charge level Battery charger Battery is charging. The on time of the LED indicates the current charge level. The on time of the LED gets longer as the charge level increases. It only flashes briefly at the start of the charging process and stays on continuously at the end of the charging process. Battery is fully charged, or the temperature has exceeded/fallen below the permissible range for the knee joint during charging. Check current charge level (see page 19). 15.3 Directives and manufacturer's declaration 15.3.1 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) 50 Kenevo 3C60/3C60=ST Appendices Observe the safety notices in the section "Information on proximity to certain areas" (see page 14). Electromagnetic emissions Interference measure ments Compliance Electromagnetic environment directive HF emissions according to Group 1/class B CISPR 11 The product uses HF energy exclusively for its internal functioning. Its HF emissions are therefore very low, and interference with neighbouring electronic devices is unlikely. Harmonics according to Not applicable power IEC 61000-3-2 below 75 W Voltage fluctuations/flicker Product meets the require according to ments of the standard. IEC 61000-3-3 Electromagnetic interference immunity Phenomenon Electrostatic discharge High-frequency magnetic fields electro Magnetic fields with rated power frequencies Electrical fast transi ents/bursts Surges Line against line Conducted interference induced by high-frequency fields Voltage drops Voltage interruptions EMC basic standard or test procedure IEC 61000-4-2 IEC 61000-4-3 IEC 61000-4-8 IEC 61000-4-4 IEC 61000-4-5 IEC 61000-4-6 IEC 61000-4-11 IEC 61000-4-11 Interference immunity test level ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air, 10 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz 30 A/m 50 Hz or 60 Hz ± 2 kV 100 kHz repetition rate ± 0.5 kV, ± 1 kV 3 V 0.15 MHz to 80 MHz 6 V in ISM and amateur frequency bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz 0% UT; 1/2 period At 0, 45, 90, 135, 180, 225, 270 and 315 degrees 0% UT; 1 period and 70% UT; 25/30 periods Single phase: at 0 degrees 0% UT; 250/300 periods Interference resistance against wireless communication devices Test fre quency [MHz] 385 450 Frequency band [MHz] 380 to 390 430 to 470 Radio service Modulation TETRA 400 GMRS 460, FRS 460 Pulse modula tion 18 Hz FM ± 5 kHz devi ation 1 kHz sine Maximum power [W] 1.8 1.8 Distance [m] 0.3 Interference immunity test level [V/m] 27 0.3 28 Kenevo 3C60/3C60=ST 51 Appendices Test fre quency [MHz] 710 745 780 810 870 930 1,720 1,845 1,970 2,450 5,240 5,500 5,785 Frequency band [MHz] 704 to 787 Radio service Modulation LTE band 13, Pulse modula 17 tion 217 Hz 800 to 960 GSM 800/900, Pulse modula TETRA 800, tion iDEN 820, 18 Hz CDMA 850, GSM 800/900, LTE band 5 1,700 to 1,990 GSM 1800; Pulse modula CDMA 1900; tion GSM 1900; 217 Hz DECT; LTE band 1, 3, 4, 25; UMTS 2,400 to 2,570 Bluetooth Pulse modula WLAN 802.11 tion b/g/n, 217 Hz RFID 2450 LTE band 7 5,100 to 5,800 WLAN 802.11 Pulse modula a/n tion 217 Hz Maximum power [W] 0.2 2 2 2 0.2 Distance [m] 0.3 Interference immunity test level [V/m] 9 0.3 28 0.3 28 0.3 28 0.3 9 52 Kenevo 3C60/3C60=ST Kenevo 3C60/3C60=ST 53 54 Kenevo 3C60/3C60=ST Kenevo 3C60/3C60=ST 55 The product Kenevo is covered by the following patents: Canada CA 2 678 987; CA 2 780 511; CA 2 779 784; CA 2 780 192 China CN 102 711 672; CN 102 647 963; CN 102 762 171; CN 102 724 936; CN 102 740 803; CN 102 076 284, CN 107 530 173, CN 107 548 299, CN 104 856 787, CN 303 641 909 Germany DE 10 2008 010 281; DE 10 2009 052 887; DE 10 2015 106 384, DE 10 2015 106 389, DE 10 2015 106 391 Japan JP 5 394 579; JP 5 619 910; JP 5 678 079; JP 6 751 106, JP 6 768 704 Russia RU 2 508 078; RU 2 533 967; RU 2 572 741; RU 2 705 923, RU 2 722 448 South Korea KR 10-1 509 265 Taiwan R.O.C. Invention Patent No. I551277; I551278; I530278; I519292; I542335 USA US 8 474 329; US 8 876 912; US 9 572 690; US 9 278 013; US 9 913 739; US 9 161 847; US 10 398 575; US 10 772 743; US 10 517 744 Brazil 112012011272-4, 112012011263-5 European Patent EP 2498727 in DE, FR, GB, IT, IS, NL, SE, TR EP 2498730 in DE, FR, GB EP 2772232 in DE, GB, FR, IT, NL, SE, TR, IS; EP 2254525 in DE, FR, GB, IS, IT, NL, TR EP 2129340 in DE, FR, GB, IT, IS, NL, SE, TR EP 2498724 in DE, FR, GB, IT, IS, NL, SE, TR; EP 2498725 in DE, FR, GB EP 2498726 in DE, FR, GB, IT, IS, NL, SE, TR; EP 2278942 in DE, FR, GB, IT, NL, SE, TR, IS EP 3285695 in DE, FR, GB, IS EP 3285693 in DE, FR, GB, IS EP 3285692 in DE, FR, GB, IS Patents pending in Canada, Europe, Germany, Brazil and USA. © Ottobock · 647G1415-0=en_INT-09-2212 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