Otto Bock Kenevo 3C60 Instructions For Use Manual
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Also See for Kenevo 3C60:
- Introduction manual (241 pages) ,
- Instructions for use manual (104 pages) ,
- Instructions for use manual (36 pages)
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Summary of Contents for Otto Bock Kenevo 3C60
- Page 1 Kenevo 3C60/3C60=ST Instructions for use (qualified personnel) ..............
- Page 2 HR | INFORMACIJA Dodatno uz tiskane upute za uporabu priloženi su i drugi jezici na CD-u (vidi poleđinu). Na upit možete na dolje navedenoj adre si besplatno naručiti tiskane upute za uporabu na dotičnom jeziku. Kenevo 3C60/3C60=ST...
- Page 3 Basılmış olan kullanım kılavuzuna ilave olarak CD'de daha fazla alternatif diller bulunmaktadır (bakınız zarfın arka yüzü). İstek üzerine ilgili dilde basılmış kullanım kılavuzunu aşağıda belirtilmiş olan adresten temin edebilirsiniz. Ottobock Healthcare Products GmbH Brehmstraße 16 | 1110 Wien | Austria Service-admin.vienna@ottobock.com | Fax (+43-1) 526 79 85 Kenevo 3C60/3C60=ST...
- Page 4 Kenevo 3C60/3C60=ST...
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Page 5: Table Of Contents
..........................8.1.7 Walking up stairs ..........................8.1.8 Walking backwards ..........................Movement pattern in activity mode B (semi-locked mode) / B+ (semi-locked mode with stance phase flex ion) ..............................8.2.1 Standing ............................8.2.2 Walking ............................. 8.2.3 Sitting down ............................Kenevo 3C60/3C60=ST... - Page 6 Technical data ..............................Appendices ................................ 14.1 Symbols Used ............................ 14.2 Operating states/error signals ......................14.2.1 Signals for operating states ........................14.2.2 Warnings/error signals ........................14.2.3 Status signals ............................. 14.3 Directives and manufacturer’s declaration ....................14.3.1 Electromagnetic environment ........................ Kenevo 3C60/3C60=ST...
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Page 7: Foreword
► Please keep this document in a safe place. 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. -
Page 8: Combination Possibilities
Among other things, this relates to the body weight, mobility grade, type of activity, load capacity of the implant and bone anchoring, freedom from pain under functional load and compliance with the permissible ambient conditions (see Page 34). Kenevo 3C60/3C60=ST... -
Page 9: Application
The product may be fitted only by qualified personnel authorised by Ottobock after completing the corresponding training. If the product is to be connected to an osseointegrated implant system, the qualified personnel must also be authorised for the connection to the osseointegrated implant system. Kenevo 3C60/3C60=ST... -
Page 10: Safety
Falling due to breakage of load-bearing components. > Skin irritation due to defects on the hydraulic unit with leakage of liquid. ► Do not subject the product to mechanical vibrations or impacts. ► Check the product for visible damage before each use. Kenevo 3C60/3C60=ST... - Page 11 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. Kenevo 3C60/3C60=ST...
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Page 12: Information On The Power Supply/Battery Charging
"Technical data" contains information on the allowable temperature range (see Page 34). 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. Kenevo 3C60/3C60=ST... -
Page 13: Information On Alignment/Adjustment
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... -
Page 14: Information On Proximity To Certain Areas
► Do not operate the product in the immediate vicinity of other electronic devices. ► Do not stack the product with other electronic devices during operation. ► If simultaneous operation cannot be avoided, monitor the product and verify proper use in the existing setup. Kenevo 3C60/3C60=ST... -
Page 15: Information On Use
► The warnings and error signals have to be observed (see Page 37). ► 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... -
Page 16: Notes On The Safety Modes
Falling due to unexpected product behaviour because of changed damping behaviour. ► The warnings/error signals (see Page 37) have to be observed. ► After the safety signal has been emitted, further use of the product is prohibited. ► The product must be inspected by an authorised Ottobock Service Centre. Kenevo 3C60/3C60=ST... -
Page 17: Instructions For Use With An Osseointegrated Implant System
► Note the instructions of the clinical personnel that indicated the use of the osseointegrated implant system. 5 Scope of Delivery and Accessories Scope of Delivery • 1 pc. Kenevo 3C60=ST (with threaded connector) • 1 pc. AXON 2R17 tube adapter or •... -
Page 18: Connecting The Power Supply And Battery Charger
The joint is ready for operation only after corresponding feedback (see Page 38). 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. Kenevo 3C60/3C60=ST... -
Page 19: Display Of The Current Charge Level
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. Kenevo 3C60/3C60=ST... -
Page 20: Installing The Tube Adapter
Plumb lines in the frontal and sagittal planes (drawn from the hip joint's centre of rotation and marked during plaster cast taking and trial fitting of the check socket) will facilitate correct positioning of the lamin ation anchor or socket adapter. Kenevo 3C60/3C60=ST... -
Page 21: Checking The Socket After Bench Alignment
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... -
Page 22: Static Alignment Optimisation
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) Kenevo 3C60/3C60=ST... -
Page 23: Flexion Stop
8.1 Movement pattern in activity mode A (locked mode) 8.1.1 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. Kenevo 3C60/3C60=ST... -
Page 24: Walking
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... -
Page 25: Walking Down Stairs
8.2 Movement pattern in activity mode B (semi-locked mode) / B+ (semi-locked mode with stance phase flexion) 8.2.1 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. Kenevo 3C60/3C60=ST... -
Page 26: Walking
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... -
Page 27: Walking Down Stairs
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. Kenevo 3C60/3C60=ST... -
Page 28: Movement Pattern In Activity Mode C (Yielding Mode)
If an adequate load was not placed on the prosthesis while sitting down, the leg remains extended during this process. Due to the nearly horizontal position of the lower leg, the flex ion resistance is reduced automatically and the lower leg drops down on its own. Kenevo 3C60/3C60=ST... -
Page 29: Standing Up
3) Pull up the other leg. 8.3.7 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. Kenevo 3C60/3C60=ST... -
Page 30: Walking Down A Ramp
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. Kenevo 3C60/3C60=ST... -
Page 31: Additional Operating States (Modes)
This component was tested for three million load cycles in accordance with ISO 10328. Depending on the patient's activity level, this corresponds to a service life of three to five years. The duration of use can be individually extended depending on the intensity of use by making use of regular ser vice inspections. Kenevo 3C60/3C60=ST... -
Page 32: Identification Of The Product By The Service Center
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. 12.4 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. Kenevo 3C60/3C60=ST... - Page 33 Caution: Exposure to Radio Frequency Radiation. This device must not be co-located or operating in conjunction with any other antenna or transmitter. Responsible party: Otto Bock Health Care, LP 3820 West Great Lakes Drive Salt Lake City, Utah 84120-7205 USA...
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Page 34: Technical Data
Data rate (over the air) 2178 kbps (asymmetrical) Maximum output power (EIRP): +8.5 dBm Tube adapter Reference number 2R17 Weight 190 g -300 g / 0.42-0.66 lbs Material Aluminium Max. body weight 125 kg Protection rating IP22 Approved set screws Length 10 mm 12 mm 14 mm 16 mm Kenevo 3C60/3C60=ST... - Page 35 Max. 93% relative humidity, non-condensing Operation 0 °C/+32 °F to +40 °C/+104 °F Max. 93% relative humidity, non-condensing Protection rating IP20 Input voltage 12 V Wireless technology Frequency range 110 kHz to 205 kHz Modulation ASK, load modulation Maximum output power (EIRP) -18.00 dBµA/m @ 10 m Kenevo 3C60/3C60=ST...
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Page 36: Appendices
Please observe the instructions of your national authority pertaining to return and collection. The component supports the "Bluetooth Classic" and "Bluetooth Low Energy" Bluetooth techno logies Declaration of conformity according to the applicable European directives Serial number Lot number Article number Kenevo 3C60/3C60=ST... -
Page 37: Operating States/Error Signals
10 x long 10 x long Battery charge level Charge the battery. under 15% After the beep and vibra tion signals, the product switches to empty battery mode and then switches off. Kenevo 3C60/3C60=ST... -
Page 38: Status Signals
14.2.3 Status signals Battery charger connected LED on LED on Event power sup battery charger When connecting the power supply to the outlet, the LED on the battery charger lights up briefly Power supply and battery charger operational Kenevo 3C60/3C60=ST... -
Page 39: Directives And Manufacturer's Declaration
Environments in areas of facility home healthcare Electrostatic discharge IEC 61000-4-2 ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air, High frequency electro IEC 61000-4-3 3 V/m 10 V/m magnetic fields 80 MHz to 2.7 GHz 80 MHz to 2.7 GHz 80 % AM at 1 kHz 80 % AM at 1 kHz Kenevo 3C60/3C60=ST... - Page 40 TETRA 400 Pulse modula tion 18 Hz 430 to 470 GMRS 460, FRS 460 ± 5 kHz devi ation 1 kHz sine 704 to 787 LTE band 13, Pulse modula tion 217 Hz 800 to 960 GSM 800/900, Pulse modula tion TETRA 800, 18 Hz iDEN 820, CDMA 850, GSM 800/900, LTE Band 5 Kenevo 3C60/3C60=ST...
- Page 41 CDMA 1900; 1845 217 Hz GSM 1900; 1970 DECT; LTE Band 1, 3, 4, 25; UMTS 2450 2400 to 2570 Bluetooth Pulse modula tion WLAN 802.11 217 Hz b/g/n, RFID 2450 LTE band 7 5240 5100 to 5800 WLAN 802.11 Pulse modula a/n tion 5500 217 Hz 5785 Kenevo 3C60/3C60=ST...
- Page 42 Kenevo 3C60/3C60=ST...
- Page 43 Kenevo 3C60/3C60=ST...
- Page 44 EP 2498730 in DE, FR, GB Patents pending in Brazil, Canada, China, EPA, Germany, Japan, Russia, Taiwan and USA. Otto Bock Healthcare Products GmbH Brehmstraße 16 · 1110 Wien · Austria T +43-1 523 37 86 · F +43-1 523 22 64...