Otto Bock X2 Instructions For Use Manual
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Otto Bock X2 Instructions For Use Manual

Bionic prosthetic system
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X2 - Bionic Prosthetic System
Instructions for Use ............................................................ 2
© Otto Bock · 647G686-04-1105

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Summary of Contents for Otto Bock X2

  • Page 1 X2 - Bionic Prosthetic System Instructions for Use ............2 © Otto Bock · 647G686-04-1105...
  • Page 2 4R57 4R41 4R111=N 4R119 4R40 4R118 4R104=75 4R57=ST 4R43 4R111 4E60 4R89 4R116 with Pyramid Adapter with Screw Top 4X258 4X350 3B5-X2 3B5-X2=ST 4X259 2R20 2R21 (with Torsion) 1D35 1C30/1C31 1M10 1C40 4X1=* X-Soft 60X5 BionicLink PC 1C60 1E56 1E57...

  • Page 3: Table Of Contents

    3.2 Connecting the AXON Tube Adapter .....................15 3.3 Starting the Program ........................17 3.4 Closing the Program ........................18 3.5 Establish connection between the 3B5-X2/3B5-X2=ST Knee Joint and X-Soft .......18 3.6 Entering the Basic Data in X-Soft ....................20 3.7 Entering the Patient‘s Data in X-Soft ....................21 4 Torque Values of the Screw Connections ..................22...
  • Page 4 7 Remote Control ..........................39 7.1 Introduction.............................39 7.2 Control Elements of the Remote Control ..................40 7.3 Initial Connection between the Remote Control and the 3B5-X2 / 3B5-X2=ST Knee Joint (Pairing) .40 7.4 Status Bar ............................41 7.5 MyMode Switching via Remote Control...................41 7.6 Changing Prosthesis Settings ......................41...

  • Page 5: Intended Use

    (distance between the knee axis and the centre point of the lower pyramid-shaped receptacle at the AXON Tube Adapter) of the 3B5-X2 / 3B5-X2=ST Knee Joint with a AXON Tube Adapter must be 310 mm if 2R20 is used and 344 mm if 2R21 is used.

  • Page 6: Qualifications Of The Prosthetist

    Failure to comply with the Safety Instructions. Failure to follow the safety instructions below can lead to control errors or malfunction of the 3B5-X2 / 3B5-X2=ST Knee Joint and result in risk of injuries for the patient as well as damage to the 3B5-X2 / 3B5-X2=ST Knee Joint.
  • Page 7 Combine the 3B5-X2 / 3B5-X2=ST Knee Joint with adapters and feet tested by Otto Bock only. Otto Bock shall not accept any liability if the 3B5-X2 / 3B5-X2=ST Knee Joint is used with prosthetic feet other than those specified (see System Overview, page 2).

  • Page 8: Patient Information

    Otto Bock Service Center for inspection. Please contact your prosthetist. • If the 3B5-X2 / 3B5-X2=ST Knee Joint comes into contact with salt water, immediately clean it with a cloth mois- tened with freshwater and let it dry. The knee joint must then be sent to an authorised Otto Bock Service Center for inspection.
  • Page 9 If activities are continued despite the vibration signals, there is the risk of overheating the hydraulic element and, in extreme cases, of damage to the 3B5-X2 / 3B5-X2=ST Knee Joint. The knee joint should be brought to an autho- rised Otto Bock Service Center for inspection.

  • Page 10: Installation Of X-Soft And Connection To The Bluetooth® Environment

    Non-active safety mode. If the safety mode can no longer be activated, there is the risk that the patient will fall. If the 3B5-X2 / 3B5-X2=ST Knee Joint can no longer be set to safety mode (e.g. in the event of a short circuit due...

  • Page 11: Supported Operating Systems

    If this occurs, a corresponding amount of space must be freed up on the hard drive. All components required by the Otto Bock software will be copied onto your hard drive automatically by the installation program.
  • Page 12 Otto Bock during the registration process. • To request a license number, click the “E-mail registration” but- ton. Your data is sent to Otto Bock per e-mail. • If you do not have an e-mail account but do have access to the internet, click the “Copy to clipboard”...

  • Page 13: Uninstalling

    X-Soft cannot be accessed until the Otto Bock Data Station has been launched. INFORMATION The Otto Bock Data Station is a superordinate software platform used to launch the corresponding software pro- grammes. For this reason a separate icon for X-Soft is not created on the Windows® desktop during the installation process.

  • Page 14: Alignment And Adjustment Of The Prosthesis

    (Fig. 2b) (see the table below). 3. Remove the charger from the receiver to terminate the charging process. The 3B5-X2 / 3B5-X2=ST Knee Joint performs a self-test and is then ready for operation, provided it is connected to the AXON Tube Adapter. This is indicated via a single vibration and beep signal.

  • Page 15: Connecting The Axon Tube Adapter

    Status Status LED Charging Status Indicator Charger connected to knee joint, Weak purple Charging status indicator (green) bad connection according to the number of LEDs lit a) Charger overheating a) 2nd and 4th LED illuminated Continuous yellow. The joint is not charged. b) Knee joint overheating/too cold a) 1st, 3rd and 5th LED illuminated c) Connection may be improved by...
  • Page 16 6. Push the AXON Tube Adapter 60 mm into the 3B5-X2 / 3B5-X2=ST Knee Joint (Fig. 7). Corrections to min. 40 mm and max. 70 mm insertion depth of the AXON Tube Adapter into the knee joint are permitted.

  • Page 17: Starting The Program

    After entering the Unlock-PIN, you will be asked to enter and confirm a personal password (chosen by you). The Unlock-PIN distributed as part of training on the 3B5-X2 / 3B5-X2=ST Knee Joint can always be used instead of the personal password. Upon doing so, you will once again be asked to enter and confirm a personal password...

  • Page 18: Closing The Program

    2. Click the Connect button to establish the Bluetooth® connection between X-Soft and the 3B5-X2 / 3B5-X2=ST Knee Joint. If several 3B5-X2 / 3B5-X2=ST Knee Joints are within range, the serial numbers will be displayed in a pop-up window. The serial number is found on the right inside of the knee joint frame when looking at the hydraulics. Select the desired 3B5-X2 / 3B5-X2=ST Knee Joint.
  • Page 19 After a connection has been successfully established, the data is imported from the knee joint and copied to the cor- responding fields in the Otto Bock Data Station on the PC. INFORMATION The range of the Bluetooth® connection is around 10 metres, but this can vary depending on the local conditions.

  • Page 20: Entering The Basic Data In X-Soft

    3.6  Entering the Basic Data in X-Soft  Entering the basic data in the Task details window provides the basis for calculations of the motion control and indi- vidual setup recommendations for the prosthetic limb. CAUTION Incorrect data entry in X-Soft. If incorrect data is entered in the X-Soft adjustment software, this can adversely affect the behaviour of the prosthetic limb.

  • Page 21: Entering The Patient's Data In X-Soft

    Tube adapter configuration tool Use the button to summon the ankle adapter configuration tool. 1. Select the foot type. 2. Select the foot size. Only available sizes for the selected foot type are displayed. 3. The system height of the foot is preselected from a data table. If additional adapters have been used, enter the system height of the foot manually (for example, when using a 4R84, 32 mm have to be added to the system height of the foot).

  • Page 22: Torque Values Of The Screw Connections

    INFORMATION Before completing entry of the patient data, check that it is complete and correct. Use the Save function of the Otto Bock Data Station to allow you to load a patient’s data again subse- quently. 4 Torque Values of the Screw Connections CAUTION Failure to comply with torque values.

  • Page 23: Basic Prosthetic Limb Alignment With X-Soft

    5 Basic Prosthetic Limb Alignment with X-Soft A calibrated alignment recommendation for basic prosthesis alignment is provided to reflect the individual conditions of the prosthesis and patient represented by the patient data entered. All alignment tools use the same reference system (positive or negative values for the distance specifications): INFORMATION During basic prosthesis alignment, ensure the knee joint is fully extended.
  • Page 24 • To determine the socket flexion, indicate the middle of the socket laterally using a proximal and distal point (e.g. on adhesive tape). Draw a line through both points from the edge of the socket to the end. • The position of the pyramid connection on the socket adapter relative to the knee joint may require the use of a sliding adapter (e.g.

  • Page 25: Static Alignment Optimisation With X-Soft

    Optimised alignment of the prosthesis components can reduce the effort required from the patient. INFORMATION During static alignment optimisation, the 3B5-X2 / 3B5-X2=ST Knee Joint is automatically locked in the bending direction (see Section 5.2.1 “Adjusting Stance Phase Control“). This should enable the patient to stand in a stable...

  • Page 26: Conditions For Measurement Validity

    • The tips of the feet are level and the feet are positioned symmetrically. 2. Measurements of 3B5-X2 / 3B5-X2=ST Knee Joint which are checked in the X-Soft adjustment software: • The prosthetic leg is loaded with at least 35% of the bodyweight.
  • Page 27 INFORMATION Due to the individual habits of the patient and because no information on the alignment in the frontal plane is inclu- ded in the calculation, the optimisation recommendations should be viewed primarily as guidelines that may include inapplicable or even contradictory information in some isolated cases (see Section 11 "Legal Nots, Liability and CE Conformity for X-Soft").

  • Page 28: Configuring The Prosthesis Control Via X-Soft

    INFORMATION When the patient becomes accustomed to the new prosthesis, his/her gait pattern will change. It is therefore ad- visable to perform the complete configuration process again approx. two weeks after initial fitting with the 3B5-X2 / 3B5-X2=ST Knee Joint.
  • Page 29 (see Section 9 "Important Information for Users"). • Heed the vibration signals and audible warning signals (beeps) of the 3B5-X2 / 3B5-X2=ST Knee Joint. • Particular caution is required when carrying children down stairs.

  • Page 30: Adjusting The Swing Phase Control

    5.2.2  Adjusting the Swing Phase Control Swing phase control influences the amount of time it takes for the prosthetic leg to swing through to an extended position, as well as the ground clearance during the swing. Swing phase control therefore influences the symmetry of the gait pattern. Swing phase angle: The swing phase angle at which the knee starts to extend again is approx.

  • Page 31: Functions In Basic Mode

    If the patient is in a sitting position for more than five seconds, i.e., the thigh is close to horizontal and the leg is not loaded, the 3B5-X2 / 3B5-X2=ST Knee Joint switches the resistance to a minimum in both the flexion and extension directions.
  • Page 32 Alternating stair ascent Although the 3B5-X2 / 3B5-X2=ST Knee Joint is a passive knee joint, i.e. cannot perform any active motions of its own accord, alternating stair ascent is possible using the 3B5-X2 / 3B5-X2=ST Knee Joint. To use this function you must first place the prosthetic foot on the next step up with a bent knee.

  • Page 33: Selecting Mymodes

    Running function The 3B5-X2 / 3B5-X2=ST Knee Joint detects a transition from walking to running and reacts accordingly by switching into a swing phase with a larger swing angle appropriate for running and zero preflex angle. The running function will work with specialized running feet such as the 1E90 Sprinter as well as with prosthetic feet with axial compression such as the 1C61 Triton Vertical Shock.
  • Page 35 This data is required for communication with the remote control. INFORMATION Running requires the usage of a running foot such as the 1E90 Otto Bock Sprinter. For details on assembly and alignment please refer to the Instructions for Use of the foot.

  • Page 36: Setting The Resistance In Safety Mode

    5.2.5  Setting the Resistance in Safety Mode If the knee joint software detects a malfunction, or when the battery is flat, the 3B5-X2 / 3B5-X2=ST Knee Joint swit- ches to the configurable safety mode (see Section 9.1 “Safety Messages and Safety Modes“). Setting the safety mode flexion resistance: We recommend a safety mode flexion resistance of 150.

  • Page 37: Setting The Pitch And Volume Of The Audible Warning And Information Signals

    5.2.6  Setting the Pitch and Volume of the Audible Warning and Information Signals Setting pitch and volume: Use the controllers for Pitch and Volume to set the audible signals of the knee joint at values acceptable for the pa- tient. The confirmation signal which sounds after the change corresponds to the setting. INFORMATION Warning signals, however, always have the highest volume setting and a fixed frequency.

  • Page 38: Mymode Motion Switching

    All current values in the knee joint are shown in the Value in knee joint column. The Value in database column shows the last settings saved in the Otto Bock Data Station for the knee joint. Select the Expert function checkbox to change the basic mode settings directly.

  • Page 39: Remote Control

    After the audible signal sounds (one long beep), your weight must be taken off the prosthesis entirely for at least one second with the knee extended (no ground contact). Then the 3B5-X2 / 3B5-X2=ST Knee Joint switches to the first MyMode and emits two short beep signals.

  • Page 40: Control Elements Of The Remote Control

    4. Charging receptacle. 7.3  Initial Connection between the Remote Control and the 3B5-X2 / 3B5-X2=ST Knee Joint  (Pairing) 1. Press the enter button to activate the Remote Control. The start-up screen with the date, time and charge status of the Remote Control is displayed. Without additional input, the Remote Control turns off automatically after 5 se- conds.

  • Page 41: Status Bar

    7.4  Status Bar The status bar shows: 1. Battery status of the Remote Control 2. Battery status of the knee joint 3. Current MyMode 4. In case of a deviation in the knee joint (e.g. when the charger is connected), an exclamation mark is shown in the status bar at the top right.
  • Page 42 4. The list of parameters can be closed without making changes by selecting and confirming the arrow symbol. Press to access the arrow symbol. 5. Select and confirm "Remote off" to switch off the Remote Control. If the settings of another MyMode are to be modified, you must first switch to this MyMode (see Section 7.5 "MyMode Switching via Remote Control").

  • Page 43: Deep Sleep Mode

    7.7  Deep Sleep Mode INFORMATION Advise your patients of the information in this section. The Remote Control can be used to place the knee joint in a deep sleep mode, in which power consumption is mini- mised. The knee joint has no function in this status. It can be woken from deep sleep mode with the Remote Control or by attaching the charger.

  • Page 44: Remote Control Adjustments

    1. Selecting and confirming “Status” displays the following: • The total pedometer value ("Total") • The daily pedometer value ("Day") • The charging status of the prosthesis in percent ("Battery"). • The estimated remaining operating time of the prosthesis in hours during active use and at rest (e.g. Sitting func- tion) ("Stb/Act").

  • Page 45: Managing Prostheses

    7.10  Managing Prostheses Connections with up to four different prostheses can be stored in a single Remote Control. Conversely, a prosthesis can only be connected to a single Remote Control. Complete the following steps to add additional connections: 1. In the main menu, use to select "Remote stgs."...

  • Page 46: Charging The Remote Control

    Advise your patients of the information in this section. Pull the charging cable from the charger for the 3B5-X2 / 3B5-X2=ST Knee Joint and connect it to the charging socket of the Remote Control. Regardless of how often the Remote Control is used, it should last two months on a single charge.

  • Page 47: Charging Status

    Non-active safety mode. If the safety mode can no longer be activated, there is the risk that the patient will fall. If the 3B5-X2 / 3B5-X2=ST Knee Joint can no longer be set to safety mode (e.g. in the event of a short circuit due to water damage), the patient must actively secure the knee joint with the residual limb musculature upon heel strike and visit a prosthetist as soon as possible.

  • Page 48: Warranty

    Otto Bock offers an extensive warranty service on the basis of the current 3B5-X2 Service and Warranty Concept. For details, please consult the 3B5-X2 Service Pass (646D535=*) included in the scope of delivery. In the interests of the medical supply company providing the fitting, the instruction of the patient and the transfer of the leg prosthesis system must be confirmed by the patient in writing.

  • Page 49: Symbols On The Inductive Charger

    9.9  Symbols on the Inductive Charger Declaration of conformity according to the European Directive for Medical Devices 93/42/EEC. This product may not be disposed of with regular domestic waste. Disposal that is not in accordance with the regulations of your country may have a detrimental impact on health and the environment. Ple- ase observe the information provided by the responsible authorities in your country regarding return and collection processes.
  • Page 50 Plantar flexion Dorsiflexion Posterior socket shifting Anterior socket shifting Knee flexion Knee extension Thomas test: The Thomas test is a method to determine the range of motion of the hip and, in particular, a hip flexion contracture. 1. To determine the extent of hip flexor contracture, the patient lies on an examination table or other level surface without their prosthesis.

  • Page 51: Legal Notes, Liability And Ce Conformity For X-Soft

    Otto Bock and / or the licenser of Otto Bock expressly reserve all ownership and / or other rights to the Otto Bock software.
  • Page 52 • The third party to whom the rights are to be assigned accepts the terms and conditions of this license agreement, • the entire Otto Bock software, and not just parts thereof, is assigned and • You do not retain any copies of the Otto Bock software, not even in the main memory or cache of your computer. 4. Warranty Any warranty for the Otto Bock software is based on the terms and conditions under which you were granted the right to use the Otto Bock software.

  • Page 53: Liability

    The declaration of conformity was therefore created by Otto Bock with sole responsibility according to Appendix VII of the guidelines. The 3B5-X2 / 3B5-X2=ST Knee Joint also meets the requirements of the 1999/5/EC Directive for radio equipment and telecommunications terminal equipment. Conformity assessment was carried out by Otto Bock according to Appendix IV of the directive.
  • Page 56 Otto Bock Healthcare Products GmbH Kaiserstraße 39 · 1070 Wien / Austria Phone (+43-1) 523 37 86 · Fax (+43-1) 523 22 64 info.austria@ottobock.com · www.ottobock.com Otto Bock has a certifi ed Quality Management System in accordance with ISO 13485.

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