Otto Bock Genium 3B1-3 Instructions For Use Manual
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- User instructions (75 pages) ,
- Instructions for use manual (108 pages) ,
- Instructions for use manual (56 pages)
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Summary of Contents for Otto Bock Genium 3B1-3
- Page 1 Genium 3B1-3/3B1-3=ST Instructions for use (qualified personnel) ..............
- Page 2 Quick Reference Guide This "Quick Reference Guide" does not replace the instructions for use Genium 3B1-3/3B1-3=ST...
- Page 3 7.1.2 715H1=2 719R3 7.1.3 710D4 710D4 15Nm basic 70 mm 60 mm 40 mm Genium 3B1-3/3B1-3=ST...
- Page 4 7.1.8 5 mm 3 mm 7.1.1.3 5 sec 7.1.6 Connection Job Specification Alignment Basic Mode Genium 3B1-3/3B1-3=ST...
- Page 5 Stance phase Swing phase Functions in the gait cycle Additional functions Additional functions Stance phase Swing phase Functions in the gait cycle Additional functions Stance phase Swing phase Functions in the gait cycle Additional functions 7.1.8 5 mm 3 mm Genium 3B1-3/3B1-3=ST...
- Page 6 Tighiening iorque in ihe direciion of roiaiion and screw geomeiry Use a torque wrench Wrong Righi Duration Cockpit App Use the adjustment software A successful connection between the product and the adjustment software is established Fill in the fields in the adjustment software Check the values Genium 3B1-3/3B1-3=ST...
- Page 7 HR | INFORMACIJA Dodatno uz tiskane upute za uporabu priloženi su i drugi jezici na CD-u (vidi poleđinu). Na upit možete na dolje navedenoj adresi besplatno naručiti tiskane upute za uporabu na dotičnom jeziku. Genium 3B1-3/3B1-3=ST...
- Page 8 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 Genium 3B1-3/3B1-3=ST...
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Page 9: Table Of Contents
Bench alignment in alignment apparatus ....................7.1.6 Static alignment optimisation ........................ 7.1.7 Dynamic alignment optimisation ......................7.1.8 Checking the socket after bench alignment .................... 7.1.9 Flexion stop ............................Optional: Installing the foam cover ......................Cockpit app ................................ System Requirements .......................... Genium 3B1-3/3B1-3=ST... - Page 10 Storage and bleeding ............................Cleaning ................................Maintenance ..............................14.1 Identification of the product by the Service Center .................. Legal information .............................. 15.1 Liability .............................. 15.2 Trademarks ............................15.3 CE conformity ............................. 15.4 Local Legal Information ........................Technical data ..............................Genium 3B1-3/3B1-3=ST...
- Page 11 Operating states/error signals ......................17.2.1 Signals for operating states ........................17.2.2 Warnings/error signals ........................17.2.3 Error messages while establishing a connection with the cockpit app ............17.2.4 Status signals ............................. 17.3 Directives and manufacturer’s declaration ....................17.3.1 Electromagnetic environment ........................ Genium 3B1-3/3B1-3=ST...
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Page 12: Foreword
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. -
Page 13: Combination Possibilities
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 Genium 3B1-3/3B1-3=ST... -
Page 14: 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. Genium 3B1-3/3B1-3=ST... -
Page 15: Safety
► Inform the patient that the changed damping characteristics have to be verified after switching to a MyMode/basic mode. ► Ensure that the patient stands securely during all switching processes. ► To deactivate mute mode, connect and then disconnect the battery charger. Genium 3B1-3/3B1-3=ST... - Page 16 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. Genium 3B1-3/3B1-3=ST...
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Page 17: Information On The Power Supply/Battery Charging
► 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 instructions stipulated by the manufacturer of the implant. Genium 3B1-3/3B1-3=ST... -
Page 18: Information On Alignment/Adjustment
(see the section "Technical data" see Page 49). ► The tube clamp screws 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. Genium 3B1-3/3B1-3=ST... - Page 19 Safety mode flexion resistance set too low Falling due to unexpected product behaviour as the result of switching into safety mode. ► Safety mode flexion resistance should be configured so that it is possible to stand safely without the knee joint buckling. Genium 3B1-3/3B1-3=ST...
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Page 20: Information On Proximity To Certain Areas
► 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. Genium 3B1-3/3B1-3=ST... - Page 21 ► Make sure that the patient is standing safely when using the stance function and checks the lock of the knee joint before placing his/her full weight on the prosthesis. ► Inform the patient whether and in what way the stance function was configured in the adjustment software. Information on the stance function see Page 34. Genium 3B1-3/3B1-3=ST...
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Page 22: Notes On The Safety Modes
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. Genium 3B1-3/3B1-3=ST... -
Page 23: Scope Of Delivery And Accessories
The following components are not included in the scope of delivery and may be ordered separately: • 4X880=* Genium Protective Cover • 4X258 installation tool for inductive charger • 3S26 cosmetic foam cover • 4H99 Genium 7.5° flexion stop • 3F1=2 Functional cosmesis Genium 3B1-3/3B1-3=ST... -
Page 24: Charging The Battery
→ Once the product battery is fully charged, all LEDs on the side of the battery charger light up. 3) After the charging process is complete, hold the prosthesis still and remove the inductive charger from the receiver. → A self-test is performed. The joint is operational only after corresponding feedback (see Page 55). Genium 3B1-3/3B1-3=ST... -
Page 25: Display Of The Current Charge Level
38% – Charge level of battery for currently connected component 6.3.3 Display of the current charge level during the charging process During the charging process, the current battery charge level is indicated by the number of LEDs lit on the side of the charger. Genium 3B1-3/3B1-3=ST... -
Page 26: Preparing The Product For Use
→ 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. Genium 3B1-3/3B1-3=ST... -
Page 27: Data Transfer Between The Product And The Pc
Damage to the cable due to inserting the tube adapter too far Falling due to unexpected product behaviour as the result of switching into safety mode. ► To avoid damaging the cable, do not slide the tube adapter in to the stop, but only to a maximum of 70 mm. Genium 3B1-3/3B1-3=ST... -
Page 28: Adjusting The Torsion Moment On The 2R21 Axon Tube Adapter
7.1.6 Static alignment optimisation The adjustment software specifies concrete reference values based on measurement data to help optimise the alignment. A precondition is that the alignment recommendations were followed during bench alignment of the prosthesis. Genium 3B1-3/3B1-3=ST... -
Page 29: Dynamic Alignment Optimisation
4H99 flexion stop (optional accessory): reduction of the maximum flexion angle by 7.5° • 4H100 flexion stop (in scope of delivery): reduction of the maximum flexion angle by 15° • 4H103* flexion stop (already installed on delivery): reduction of the maximum flexion angle by 22.5° Genium 3B1-3/3B1-3=ST... -
Page 30: Optional: Installing The Foam Cover
If the distance between the battery charger and charging receiver is greater than 2 mm, the knee joint cannot be charged anymore. This is indicated by feedback on the battery charger (see Page 53). However, charging should not be a problem if there is a sock or SuperSkin between the transmitter and receiver of the charger. Genium 3B1-3/3B1-3=ST... -
Page 31: Cockpit App
(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. Genium 3B1-3/3B1-3=ST... -
Page 32: Control Elements For Cockpit App
7. Display and name of the currently selected mode (e.g. 1. Basic Mode) 100% 1. Basic Mode Mute mode is activated 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. Genium 3B1-3/3B1-3=ST... -
Page 33: Cockpit App Navigation Menu
If establishing a connection to a component is not possible, perform the following steps: ► Delete the component from the Cockpit app if applicable (see the section "Deleting a component") ► Add the component again in the Cockpit app (see the section "Adding a component") Genium 3B1-3/3B1-3=ST... -
Page 34: Deleting A Component
Intuitive locking of the joint The intuitive stance function 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 Genium 3B1-3/3B1-3=ST... -
Page 35: Walking
3) Move the buttocks in the direction of the back support and lean the upper body forward. INFORMATION: Resistance while sitting down can be changed with the Cockpit app via the parameter “Resistance” (see Page 39). Genium 3B1-3/3B1-3=ST... -
Page 36: Sitting
4) Stand up with support from the hands while keeping weight evenly distributed on feet. 9.1.7 Walking up stairs step-over-step INFORMATION To use this function, it needs to be enabled in the adjustment software. It also has to be activated using the Cock pit app (see Page 39). Genium 3B1-3/3B1-3=ST... -
Page 37: Overcoming Obstacles
2) Briefly extend the hip. 3) Quickly flex the hip. This causes the knee to flex. 4) With the knee flexed, step over the obstacle. With sufficient knee flexion, the extension resistance is increased to allow enough time for crossing the obstacle. Genium 3B1-3/3B1-3=ST... -
Page 38: Walking Down Stairs
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. Genium 3B1-3/3B1-3=ST... -
Page 39: Changing The Prosthesis Setting Using The Cockpit App
Further information (see Page 36). Stair Function Deactivated 0 - deactivated Activating/deactivating the stair and obstacle Activated 1 - activated function. For switching with the Cockpit app, this function has to be activated in the adjust ment software. Further information (see Page 36). Genium 3B1-3/3B1-3=ST... -
Page 40: Overview Of Adjustment Parameters In Mymodes
1000 Hz–4000 Hz 1000 Hz–4000 Hz Pitch of beep signal for confirmation tones Volume 0–4 0–4 Volume of beep signal for confirmation tones (e.g. when checking the charge level, switch ing MyModes). The "0" setting deactivates the audible feedback signals. However, warning signals are still generated if errors occur. Genium 3B1-3/3B1-3=ST... -
Page 41: Turning Bluetooth On The Prosthesis On/Off
Mute mode can be activated/deactivated using the Cockpit app. INFORMATION Connecting the battery charger automatically deactivates mute mode again. 9.5.1 Turning mute mode on/off using the Cockpit app 1) When the component is connected, tap the symbol in the main menu. Genium 3B1-3/3B1-3=ST... -
Page 42: Deep Sleep Mode
Dynamic stability control (DSC) DSC ensures the knee will not release stance resistance during biomechanically unstable static and dynamic con ditions. Constantly checking multiple parameters, DSC ensures the optimally timed decision for the knee to safely Genium 3B1-3/3B1-3=ST... -
Page 43: Mymodes
If the Volume parameter is set to '0' in the Cockpit app (see Page 38) or if mute mode (silent mode) is activated, there are no beep signals. Once a connection to a prosthesis has been established, the cockpit app can be used to switch between the MyModes. Genium 3B1-3/3B1-3=ST... -
Page 44: Switching Mymodes Using Motion Patterns
INFORMATION: If this beep and vibration signal does not sound, the requirements were not observed when bouncing the foot or mute mode (silent mode) is activated. For more information about mute mode, see the section "Mute mode" (see Page 41). Genium 3B1-3/3B1-3=ST... -
Page 45: Switching From A Mymode Back To Basic Mode
11.2 Mode for charging the prosthesis The product is non-functional during charging. The product is set to safety mode damping. This may be low or high depending on the setting in the adjustment software. Genium 3B1-3/3B1-3=ST... -
Page 46: Safety Mode
Avoid extended disuse of the product (use the product regularly). 13 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. Genium 3B1-3/3B1-3=ST... -
Page 47: Maintenance
15.3 CE conformity Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with European require ments for medical devices. The product meets the requirements of the RoHS Directive 2011/65/EU on the restriction of the use of certain haz... -
Page 48: Local Legal Information
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... -
Page 49: Technical Data
Maximum possible flexion angle with 4H99 flexion stop 127.5° Maximum possible flexion angle with 4H100 flexion stop 120° Maximum insertion depth of the tube adapter in the knee 70 mm joint Weight of the prosthesis without tube adapter and Pro Approx. 1,500 g tective Cover Genium 3B1-3/3B1-3=ST... - Page 50 Approx. 5 days with average use battery at room temperature Power supply unit Reference number 757L16-4 Type FW8001M/12 Storage and transport in original packaging -40 °C/-40 °F to +70 °C/+158 °F 10% to 95% relative humidity, non-condensing Storage and transport without packaging -40 °C/-40 °F to +70 °C/+158 °F 10% to 95% relative humidity, non-condensing Genium 3B1-3/3B1-3=ST...
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Page 51: Appendices
Proximal prosthesis components with threaded connect 10 Nm / 89 lbf. In. Flexion stop 1 Nm / 5 lbf. In. 17 Appendices 17.1 Symbols Used Manufacturer Type BF applied part Compliance with the requirements according to "FCC Part 15" (USA) Compliance with the requirements under the "Radiocommunications Act" (AUS) Genium 3B1-3/3B1-3=ST... -
Page 52: Operating States/Error Signals
Medical device Caution, hot surface Protect from moisture Please note the instructions for use Check product settings using corresponding adjustment software Ottobock Data Station. 17.2 Operating states/error signals The prosthesis indicates operating states and error messages through beeps and vibration signals. Genium 3B1-3/3B1-3=ST... -
Page 53: Signals For Operating States
Ottobock Service Center. 10 x long 10 x long Battery charge level 5% Charge the battery. After the beep and vibra tion signals, the product switches to empty battery mode and then switches off. Genium 3B1-3/3B1-3=ST... - Page 54 LED 3 is lit up The prosthesis is not being Connection charged improved by reducing the distance between the char Distance between battery ger and receiver of the char charger and receiver of the ging unit. charging unit too great. Genium 3B1-3/3B1-3=ST...
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Page 55: Error Messages While Establishing A Connection With The Cockpit App
Power supply and battery charger operational. Battery charger not yet connected to receiver. Battery charger connected to receiver, good connection. This display turns off automatically after approximately one minute to avoid bother some light at night. The charging process is not affected. Genium 3B1-3/3B1-3=ST... -
Page 56: Directives And Manufacturer's Declaration
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 ments of the standard. IEC 61000-3-3 Genium 3B1-3/3B1-3=ST... - Page 57 380 to 390 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 Genium 3B1-3/3B1-3=ST...
- Page 58 CDMA 1900; 1,845 217 Hz GSM 1900; 1,970 DECT; LTE band 1, 3, 4, 25; UMTS 2,450 2,400 to 2,570 Bluetooth Pulse modula tion WLAN 802.11 217 Hz b/g/n, RFID 2450 LTE band 7 5,240 5,100 to 5,800 WLAN 802.11 Pulse modula a/n tion 5,500 217 Hz 5,785 Genium 3B1-3/3B1-3=ST...
- Page 59 Genium 3B1-3/3B1-3=ST...
- Page 60 EP 2772232 in DE, GB, FR, IT, NL, SE, TR, IS Patents pending in Brazil, Germany and USA Otto Bock Healthcare Products GmbH Brehmstraße 16 · 1110 Wien · Austria T +43-1 523 37 86 · F +43-1 523 22 64...