Otto Bock X2 User manual

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

2
Adapter
Inductive Charger /
AC Adapter
Knee Joint / Remote Control
Installation Ring and Tool for Inductive Charger
AXON Tube AdapterProsthetic Foot
BionicLink PC / X-Soft
4R57
4R57=ST
4R41
4R43
4R89
4R40
4R104=60
4R104=75
4R111=N
4R111
4R116
4R118
60X5 BionicLink PC
4X1=* X-Soft
2R21 (with Torsion)2R20
4X259
4X258
4R119
1E56
1D35
1C30/1C31 1C40
1M10
1C60 1E57
757L16-3
4E60
4X350
3B5-X2
with Pyramid Adapter
3B5-X2=ST
with Screw Top

3
Table of Contents
INFORMATION
These Instructions for Use were last updated on May 25th, 2011.
1 Intended Use ......................................................................................................................................5
1.1 Medical Purpose ...............................................................................................................................5
1.2 Field of Application ...........................................................................................................................5
1.3 Conditions of Use .............................................................................................................................5
1.4 Qualications of the Prosthetist .........................................................................................................6
1.4.1 Qualications of the Therapist and Nursing Staff ...........................................................................6
1.5 Functions ..........................................................................................................................................6
1.6 Safety Instructions ............................................................................................................................6
1.7 Scope of Delivery ..............................................................................................................................6
1.8 Recommended Accessories ..............................................................................................................6
1.9 General Safety Instructions ...............................................................................................................6
1.10 Patient Information ..........................................................................................................................8
2 Installation of X-Soft and Connection to the Bluetooth® Environment ............................................10
2.1 Recommended PC Hardware Specications ..................................................................................10
2.2 Minimum PC Hardware Specications ............................................................................................10
2.3 Supported Operating Systems ........................................................................................................11
2.4 Additional Required Software Components ....................................................................................11
2.5 Installing .........................................................................................................................................11
2.6 Uninstalling .....................................................................................................................................13
3 Alignment and Adjustment of the Prosthesis ..................................................................................14
3.1 Charging the 3B5-X2 / 3B5-X2=ST Knee Joint ..............................................................................14
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
5 Basic Prosthetic Limb Alignment with X-Soft ..................................................................................23
5.1 Static Alignment Optimisation with X-Soft .......................................................................................25
5.1.1 Conditions for Measurement Validity ............................................................................................26
5.1.2 Entering Measurements ...............................................................................................................26
5.2 Conguring the Prosthesis Control via X-Soft .................................................................................28
5.2.1 Adjusting the Stance Phase Control ...........................................................................................28
5.2.2 Adjusting the Swing Phase Control ..............................................................................................30
5.2.3 Functions in Basic Mode ..............................................................................................................31
5.2.4 Selecting MyModes .....................................................................................................................33
5.2.5 Setting the Resistance in Safety Mode .........................................................................................36
5.2.6 Setting the Pitch and Volume of the Audible Warning and Information Signals .............................37
5.2.7 Data Overview after Conguring the Prosthetic Controls ............................................................37

4
6 MyMode Motion Switching ...............................................................................................................38
6.1 Switching to MyModes without a Remote Control ...........................................................................38
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
7.7 Deep Sleep Mode ...........................................................................................................................43
7.8 Querying the Prosthesis Status .......................................................................................................43
7.9 Remote Control Adjustments ..........................................................................................................44
7.10 Managing Prostheses ...................................................................................................................45
7.11 Connecting to the Prosthesis during Normal Operation .................................................................45
7.12 Charging the Remote Control .......................................................................................................46
8 Completing the Fitting ......................................................................................................................46
9 Important Information for Users ......................................................................................................46
9.1 Safety Messages and Safety Modes ...............................................................................................46
9.2 Charging Status ............................................................................................................................47
9.3 Storage and Bleeding .....................................................................................................................47
9.4 Service ...........................................................................................................................................47
9.5 Warranty ........................................................................................................................................48
9.6 Technical Information ......................................................................................................................48
9.7 Symbols on the Knee Joint ..............................................................................................................48
9.8 Symbols on the Remote Control ......................................................................................................48
9.9 Symbols on the Inductive Charger ..................................................................................................49
10 Denition of Terms .........................................................................................................................49
11 Legal Notes, Liability and CE Conformity for X-Soft ......................................................................51
12 Liability............................................................................................................................................53
13 CE Conformity ................................................................................................................................53

5
Explanation of Symbols in the Instructions for Use
WARNING Warnings regarding possible risks of severe accident or injury.
CAUTION Warnings regarding possible risks of accident or injury.
INFORMATION Additional information on the tting/use.
1 Intended Use
INFORMATION
Read these instructions carefully before using the 3B5-X2 / 3B5-X2=ST Knee Joint! Pay particular attention to the
safety instructions!
The patient must be taught how to handle, care for and operate his/her prosthesis properly. See the sections below:
1.3 Conditions of Use, 1.5 Functions, 1.6 Safety Instructions, 3.1 Charging the 3B5-X2 / 3B5-X2=ST Knee Joint,
6 MyMode Motion Switching, 7 Remote Control, 9 Important Information for Users, 12 Liability
1.1 Medical Purpose
The 3B5-X2 / 3B5-X2=ST Knee Joint is to be used exclusively for exoprosthetic tting of the lower limbs.
1.2 Field of Application
The patient must full the following requirements:
• The patient must full the physical and mental requirements for the perception of audible signals and/or mechani-
cal vibrations.
• The skin on the residual limb must be completely healed.
• The knee center ground measurement must be at least 318 mm (if 2R20 and 1E57 are used). The minimum distal
system height (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.
• Hip disarticulation and hemipelvectomy patients must be tted with the 7E10=* Helix3D hip joint.
INFORMATION
Advise your patients of the information in this section.
Application according to the Otto Bock MOBIS® Mobility System:
Recommended for mobility grades 2, 3 and 4 (restricted outdoor walkers, unrestricted outdoor
walkers and unrestricted outdoor walkers with especially high requirements).
Approved for body weights of up to 150 kg / 330 lbs with 2R20, or up to 125 kg / 275 lbs with
2R21.
1.3 Conditions of Use
INFORMATION
Advise your patients of the information in this section.
The 3B5-X2 / 3B5-X2=ST Knee Joint was designed for everyday activities, but not for extreme sports, such as free-
climbing, skydiving, paragliding etc. See Section 9.6 “Technical Information“ for the permitted ambient conditions.
The 3B5-X2 / 3B5-X2=ST Knee Joint is only intended for tting to amputees or dysmelia sufferers. Use of the product
on other patients is not approved by the manufacturer.

6
1.4 Qualications of the Prosthetist
Only prosthetists who have been authorised by Otto Bock after completing a corresponding training course may t
patients with the 3B5-X2 / 3B5-X2=ST Knee Joint.
1.4.1 Qualications of the Therapist and Nursing Staff
The therapists or nursing staff must be trained in handling the 3B5-X2 / 3B5-X2=ST Knee Joint (and accessories) by
the authorised prosthetist.
1.5 Functions
The 3B5-X2 / 3B5-X2=ST hydraulic knee joint system functions through the use of simulated physiologic rule sets
with auto-adaptive swing and stance phase control predicted by multi-modal proprioceptive input. The system also
provides exed-knee loading to traverse obstacles.
1.6 Safety Instructions
INFORMATION
Advise your patients of the information in this section.
CAUTION
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.
1.7 Scope of Delivery
1 pc. 3B5-X2 / 3B5-X2=ST X2 - Bionic Prosthetic System
1 pc. 4X350 Remote Control
1 pc. 757L16-3 AC Adapter
1 pc. 4E60 Inductive Charger
1 pc. 4X259 Installation Ring for Inductive Charger
1.8 Recommended Accessories
1 pc. 2R20 AXON Tube Adapter / 2R21 AXON Tube Adapter with Torsion
1.9 General Safety Instructions
CAUTION
Alignment and adjustment errors. When tting and adjusting the prosthesis, errors can occur, which can cause
malfunctions of the knee joint including loss of function due to structural failure. That can cause the patient to fall.
• Participation in an Otto Bock product training course for the 3B5-X2 / 3B5-X2=ST Knee Joint is obligatory be-
fore the rst tting. Additional product training courses may become necessary to qualify for product updates.
• Correctly entering the foot size, the prosthesis dimensions and the body weight are important criteria for the
quality of the tting. If the values are too high, the prosthesis may not trigger the swing phase. If the values are
too low, the prosthesis may trigger the swing phase at the wrong time.
CAUTION
Use of unsuitable prosthetic components. If unsuitable prosthetic components are installed in the prosthesis,
malfunction of the joint and a loss of functionality due to structural failure may occur. This may subsequently cause
the patient to fall.

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 specied (see System Overview, page 2).
CAUTION
Manipulation of system components. Independent changes and / or modications of system components may
lead to malfunction of the knee joint and a loss of functionality due to structural failure, which could subsequently
cause the patient to fall.
• Any changes or modications to the knee joint may limit its use.
• The knee joint may only be opened and repaired by authorised Otto Bock technicians and the battery may only
be handled by Otto Bock Service Centers (batteries are not user-serviceable).
CAUTION
Improper use of the knee joint. Any kind of overloading or excessive strain as well as improper use can lead to
defects with subsequent malfunctions of the knee joint and a loss of functionality due to structural failure. This can
subsequently cause the patient to fall.
The patient must be instructed in how to handle the 3B5-X2 / 3B5-X2=ST Knee Joint properly and be informed of
the patient instructions below.
CAUTION
Improper use of the Remote Control. Improper use may damage the Remote Control. This can lead to malfunction
of the Remote Control and result in unexpected actions of the joint. This can subsequently cause the patient to fall.
Instruct the patient in how to use the Remote Control correctly based on the Patient Information (646D448). Advise
the patient of the following patient instructions.
CAUTION
MyMode switching via Remote Control. When the Remote Control is used to switch MyMode, the damping pro-
perties of the knee joint are changed. In certain situations (e.g. under bending strain when cycling), this could cause
the patient to fall.
Instruct the patient in how to use the MyMode switching in MyModes based on the Patient Information (646D448).
Advise the patient of the following patient instructions.
CAUTION
Transport damage. Mechanical impact or stress during transportation of the knee joint such as shocks and vibra-
tions can lead to:
• Defects and resulting knee joint malfunctions;
• Battery and hydraulic unit defects, resulting in leaks
• Or to loss of functionality due to structural failure.
This can cause the patient to fall as well as result in skin irritation.
When transporting the knee joint, use the packaging in which it was delivered.
CAUTION
Consequences of product deterioration. Wear and tear on system components can lead to malfunction of the
knee joint, which may subsequently cause the patient to fall.
In the interest of patient safety and in order to maintain reliability and protect the warranty, the specied service
intervals must be observed.

8
1.10 Patient Information
CAUTION
Magnetic interference. The knee joint can malfunction when near high-voltage power lines, transmitters, trans-
formers, CT scanners or other sources of strong electromagnetic radiation (such as security systems for goods in
department stores). This can cause the patient to fall.
Avoid proximity to strong sources of magnetic and electric interference (e.g. transformer stations, transmitters).
CAUTION
Thermal overloading. Extended exposure to high temperatures can lead to defects and result in malfunction of the
knee joint with a loss of functionality due to structural failure. This can cause the patient to fall.
Avoid areas with extreme temperatures (see Section 9.6 "Technical Information").
CAUTION
Mechanical overloading. External mechanical impact or stress such as shocks and vibrations can lead to:
• Short circuits in the electronics and battery, resulting in malfunction of the knee joint;
• Defects of the battery and the hydraulic unit, resulting in leaks;
• Or to loss of functionality due to structural failure.
This can cause the patient to fall as well as result in skin irritation.
Do not expose system components to mechanical vibrations or shocks.
CAUTION
Penetration of dirt and humidity. Penetration of dirt and humidity into the system components can lead to:
• Short circuits in the electronics and battery, resulting in malfunction of the knee joint;
• Defects in the hydraulic unit, causing leaks;
• Or loss of functionality due to structural failure. This can cause the patient to fall as well as result in skin irritation.
• Ensure that neither solid particles nor liquids can penetrate the system components. Should the knee joint come
into contact with liquid, remove the cosmetic cover and let the components dry. The joint must then be sent to an
authorised 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. Please contact your prosthetist.
CAUTION
Improper use of the joint. Any kind of overloading or excessive strain as well as improper use can lead to:
• Defects and resulting knee joint malfunctions;
• Loss of functionality due to structural failure;
• Or battery and hydraulic unit defects resulting in leaks.
This can cause the patient to fall as well as result in skin irritation.
The 3B5-X2 / 3B5-X2=ST Knee Joint was developed for everyday use and must not be used for unusual activities
such as extreme sports (free climbing, paragliding, etc.).
Careful handling of the prosthesis and its components not only increases their service life but, above all, ensures
your personal safety. Should the prosthesis be subjected to extreme impacts (e.g. by falling or similar), it must be
inspected immediately for possible damage by a prosthetist. If necessary, the responsible prosthetist will pass the
prosthesis on to Otto Bock Service.

9
CAUTION
Overheating of the hydraulic unit. Extended heavy use (e.g. lengthy downhill walks) can lead to:
• Overheating of the hydraulic unit and resulting malfunctions of the knee joint
• Or to defects in the hydraulic unit and associated leaks.
This can cause the patient to fall as well as result in skin irritation. Touching overheated components can also cause
burns.
Please take note of pulsating vibration signals. They indicate the risk of overheating. As soon as these pulsating
vibrations begin, all activities must be stopped and the hydraulic unit be allowed to cool down. You may resume your
activities once the pulsating vibration signals stop.
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.
CAUTION
Danger of falling when descending stairs.
• When walking down stairs, the banister or handrail should always be used and the prosthetic foot should be
placed on the step so that the heel (max. centre of the foot) is close to the edge of the step to facilitate rollover.
• If the audible alarm sounds, stop descending immediately and check whether stance phase control is active (see
Section 9, “Important Information for Users“).
• Observe the vibration and audible signals (beeps) of the 3B5-X2 / 3B5-X2=ST Knee Joint.
• Particular caution is required when carrying children down stairs.
CAUTION
Improper MyMode switching. If an improper MyMode switching procedure into basic mode or vice versa occurs,
there is a danger of falling (see Section 7.5 “MyMode Switching via Remote Control“)!
•
When you switch to a MyMode, check the function, as you may have activated a MyMode other than the intended
on (see Section 6 “ MyMode Motion Switching “ and Section 7.5 “ MyMode Switching via Remote Control“ ).
• Ensure that you return to basic mode when you have completed your activities in the MyMode.
CAUTION
MyMode switching via Remote Control. The patient can use the Remote Control to initiate different actions chan-
ging the damping behaviour of the knee joint. In certain situations, this can cause the patient to fall.
If you inadvertently selected the wrong action with the Remote Control (vibration or audible signal), take the strain
off the 3B5-X2 / 3B5-X2=ST Knee Joint and correct the command.
CAUTION
Consequences of product deterioration. Wear and tear on system components can lead to malfunction of the
knee joint, which may subsequently cause the patient to fall.
For your own safety and to maintain operational safety and preserve the warranty, comply with the specied service
and inspection intervals.
WARNING
Danger of accidents when driving a motor vehicle. The ability of leg prosthesis wearers to operate a motor
vehicle is determined on a case-by-case basis. Criteria include the type of tting (amputation height, unilateral or
bilateral, residual limb conditions, design of the prosthesis) and the individual abilities of the leg prosthesis wearer.
All persons are required to observe their country’s national and state driving laws when operating motor vehicles.
For insurance purposes, drivers should have their driving ability examined and approved by an authorised test
centre. In general, Otto Bock recommends that vehicles should be professionally retrotted to meet each user's
individual needs (e.g. automatic transmission). Risk-free driving must be ensured even when the leg prosthesis is
not functioning.

10
CAUTION
Malfunction of the knee joint. Malfunctions of the knee joint can cause you to fall.
Observe the vibration signals and audible warnings (beep signals) of the 3B5-X2 / 3B5-X2=ST Knee Joint.
INFORMATION
When using exoprosthetic knee joints, servomotor, hydraulic, pneumatic or brake load dependent control functions
can cause movement noise. This kind of noise is normal and inevitable. Usually, it does not cause any problems.
If movement noise increases noticeably during the life cycle of the the knee joint, the knee joint should be inspected
by a prosthetist immediately.
CAUTION
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 entry), under certain circumstances the patient must actively secure the 3B5-X2 / 3B5-X2=ST Knee Joint
with the muscles in their residual limb on stepping on their heel until they reach the prosthetist, or until the prosthetic
limb has been replaced, and go to the prosthetist's practice without delay.
CAUTION
Danger of pinching in the hydraulic unit. Avoid reaching into the knee joint mechanism, as this results in a risk of
pinching.
2 Installation of X-Soft and Connection to the Bluetooth®
Environment
2.1 Recommended PC Hardware Specications
For 32-bit platforms:
• PC with a Pentium® IV 650 / 3.4 GHz processor (x86) or faster
• Minimum 1 GB RAM (memory)
For 64-bit platforms:
• PC with an Intel Core2 (x64) processor or faster
• Minimum 2 GB RAM (memory)
For 32-bit and 64-bit:
• At least 1 GB free hard drive space
• Graphics card with Open GL support
• Minimum resolution 1024 x 768 at 96 DPI (higher DPI settings can result in errors in the display, depending on the
resolution), 32-bit colour depth (16.7 million colours)
• CD-ROM drive or DVD-ROM drive
• 1 available USB port (if applicable)
• Mouse and keyboard
2.2 Minimum PC Hardware Specications
The minimum hardware specications depend on the minimum hardware requirements for the operating system. The
following requirements apply if they are higher:
• PC with a Pentium® III / 1 GHz processor, 32-bit (x86) or faster
• 512 MB RAM (memory)
• 1 GB free hard drive space

11
• Graphics card with Open GL support
• Resolution of 1024x768 at 96 DPI, 32-bit colour depth (16.7 million colours)
• CD-ROM drive
• 1 available USB port (if applicable)
• Mouse and keyboard
2.3 Supported Operating Systems
The following 32-bit operating systems are supported:
• Microsoft® Windows® XP Professional, SP2 or higher (recommended: SP3)
• Microsoft® Windows® XP Home Edition, SP2 or higher (recommended: SP3)
• Microsoft® Windows® Vista, all editions except Microsoft® Windows® Vista Starter (recommended: SP2)
• Microsoft® Windows® 7, all editions except Microsoft® Windows® 7 Starter
The following 64-bit operating system is supported:
• Microsoft® Windows® 7, all editions except Microsoft® Windows® 7 Starter
INFORMATION
Please note that you require the "USB drivers 2.0" driver version for Bluetooth® connection via 60X5 BionicLink PC
under Windows® 7.
2.4 Additional Required Software Components
The following additional software components are required and will be installed during installation of the software (if
they are not installed on the PC already):
• Microsoft® XML 6.1
• Microsoft® NET Framework 3.5
• Microsoft® NET Framework 3.5
INFORMATION
Before launching the install, the installation program checks to see if you have sufcient free space on your hard
drive and returns an error message if this is not the case. 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.
2.5 Installing
To start the installation program, launch Microsoft® Windows® and insert the X-Soft CD-ROM into the CD-ROM drive.
You must have administrator rights to install the software.
After starting the setup program, the Setup Wizard will take you through a number of screens where you can enter
the following information:
• Read and conrm the licence agreement
• Enter the name and company
__________________________________________________________________________________
Pentium® is a registered trademark of Intel Corporation.
Microsoft® and Windows® are registered trademarks of Microsoft® Corporation.

12
1) Enter the product code provided in the CD cover, and click the
"Next" button.
2) Enter the company information. Fields marked with an asterisk
(*) are mandatory.
3) You will then receive a summary of your data that will be trans-
mitted to 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” button. Send the clipboard
contents to [email protected] using a webmail
service (e.g. T-Online, Yahoo, etc.).
• Alternatively, click the "Print" button in order to print a hard copy
and fax it to Otto Bock.
Please send this fax to: [phone]
Otto Bock Healthcare Products GmbH - Kaiserstraße 39 - 1070
Wien - Austria
4) Click the “Cancel” button in order to interrupt the installation pro-
cess and continue it after you receive the license number.
5) Your personal license number will be sent to you within a few
working days (within one hour for e-mail requests).
6) Restart the installation process in order to complete the registra-
tion by entering the license number into the corresponding eld
(for example, see: e-mail "Austria, Registration", last point "Type
in License: xxxxxxxx). Click the "Next" button.

13
7) The path and authentication method for the patient database
are selected in the next step. If the database is installed lo-
cally, accept the default settings and click the “Next” button.
8) Select the “Install” button to start the installation process. The
installation can take a few minutes.
9) The next window informs you that the installation is complete.
10) Click the “Finish” button. The installation pro-
cess is concluded. An icon to launch the Otto
Bock Data Station has been added to the
Windows® desktop.
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.
2.6 Uninstalling
Use the Windows® uninstall function to uninstall X-Soft. Open the “Control Panel” and select “Add or Remove Pro-
grams” to display a list of all installed software packages. Select the "X-Soft" entry. When you click the "Add/Re-
move" button, all components of X-Soft are deleted from your hard drive. However, your patient data and the Data
Station will be retained.

14
3 Alignment and Adjustment of the Prosthesis
3.1 Charging the 3B5-X2 / 3B5-X2=ST Knee Joint
INFORMATION
Advise your patients of the information in this section.
INFORMATION
The battery can only be charged at temperatures above 0 °C.
It takes approx. 6-8 h for the battery in the knee joint to charge fully. The better the connection between the charger
and the receiver on the knee joint (e.g. not interrupted by the stocking), the faster the charging process.
1 2a 3
2b
1. Connect the power cord to the charger with correct polarity (Figure 1).
2. Start the inductive charging process by attaching the charger to the receiver at the rear of the knee joint. The
charger is held in place by a magnet (Fig. 1a/2b). Check the charging status via the LEDs at the side (Fig. 3). The
charging process can be monitored via the colour of the illuminated ring (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. If this it not the case, an error has occurred. If this occurs please
send the knee joint to the prosthetist or authorised Otto Bock Service Center.
INFORMATION
Hold the joint still while it is performing the self-test, i.e. immediately after removing the charger. Otherwise, error
messages may occur. They can be rectied by attaching and removing the charger.
INFORMATION
Charging is no longer possible when the distance between the transmitter and receiver is greater than 2 mm. How-
ever, charging should not be a problem if there is a sock or Superskin between the transmitter and receiver of the
charger. (See also the table “Charging process“).
Charging Status:
LEDs 0 1 2 3 4 5
Charging
status
0%-10% 10%-30% 30%-50% 50%-70% 70%-90% >90%
Charging Process:
Status Status LED Charging Status Indicator
AC Adapter is connected, but the
charger is not attached to the knee
joint.
Continuous green All ve LEDs off
Charger connected to knee joint Purple pulsing (4-second
cycle)
*
Charging status indicator (green)
according to the number of LEDs lit

15
Status Status LED Charging Status Indicator
Charger connected to knee joint,
bad connection
Weak purple
*
Charging status indicator (green)
according to the number of LEDs lit
a) Charger overheating
b) Knee joint overheating/too cold
c) Connection may be improved by
reducing the distance between the
charger and receiver.
Continuous yellow. The joint
is not charged.
a) 2nd and 4th LED illuminated
a) 1st, 3rd and 5th LED illuminated
c) 3rd LED illuminated
(see Section 3.1, Fig. 3)
Charger fault (error may be rectied
by disconnecting and reconnecting
the AC Adapter)
Flashing red. The joint is
not charged.
LEDs indicate an error code.
* This display turns off automatically after approx. one minute to avoid bothersome light at night. The charging process
is not affected.
The charging status of the knee joint is also shown on the display of the remote control.
In addition, the remaining operating time is indicated to the user by knee joint vibration signals once the remaining
battery capacity reaches approx. 25% (see table below).
In general, the tube adapter should be left as long as possible.
Vibration Signal of the
Knee Joint
Charging Status Remaining Operating Time
3x vibration 25 % approx. 24 h
5x vibration 10 % approx. 6 h
10x vibration and beeping 5 % 0 h
INFORMATION
When the knee joint is fully charged (all 5 LEDs at the side light up (see page before Fig. 3)), the maximum use
period of the knee joint before the next charging process is approx. 4 days, depending on patient activity. However,
we recommend charging the knee joint overnight every day.
3.2 Connecting the AXON Tube Adapter
4
1 2 3
1. Determine the length of 2R20/2R21 AXON Tube Adapter required with the X-Soft adjustment software.
2. Shorten the AXON Tube Adapter to the determined value with the 719R3 Tube Adapter Cutter (Fig. 1). Smooth the
cutting surface with a 718S2 Countersink and sandpaper (Fig. 2). If necessary, smooth by machine the material
raised at the outer edge when shortening the AXON Tube Adapter, and always countersink the interior to prevent
damage to the AXON Tube Adapter cable.
INFORMATION
Do not cut the AXON Tube Adapter below the 365 mm value on the tube adapter scale.
CAUTION
Risk of cable damage. If the cable is damaged when cutting the AXON Tube Adapter to length, malfunctions of the
knee joint may follow. This can subsequently cause the patient to fall.
Ensure the cable is not damaged.

16
INFORMATION
If the AXON Tube Adapter is disconnected when the knee joint is activated and the charger is not attached, a safety
mode is activated and the knee joint sends a warning signal. If the AXON Tube Adapter is connected again and
then the knee joint is reset by attaching and removing the charger, it returns to normal mode.
3. Attach the foot to the AXON Tube Adapter. To do so, tighten the screws on the AXON Tube Adapter slightly with
an Allen key (size 4 mm) (approx. 4 Nm). Fit the AXON Tube Adapter to the foot such that the printed scale faces
the front (Fig. 3).
5678
4. Attach the cable of the AXON Tube Adapter to the cable of the 3B5-X2 / 3B5-X2=ST Knee Joint (Fig. 4).
5. Push the protruding cable loop into the AXON Tube Adapter (Fig. 5). When the AXON Tube Adapter has been
shortened to the minimum length, the plug must be inserted in the cavity (Fig. 6). The cable loop must then be
stored carefully.
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.
CAUTION
Inserting the AXON Tube Adapter. If the AXON Tube Adapter is not inserted far enough into the knee joint, functio-
nal losses due to structural failure can result. This can subsequently cause the patient to fall.
For reliable operation, the AXON Tube Adapter must be inserted at least 40 mm.
INFORMATION
If the length must be adjusted by pushing the AXON Tube Adapter in or out during subsequent trials, the patient
must always be seated. Before the prosthetic limb is loaded with bodyweight after adjusting the length, the screws
on the tube clamp of the knee joint must rst be tightened to the prescribed torques.
7. Turn the foot outwards slightly, and tighten both screws on the terminal clamp slightly using an Allen key (size
4 mm) (approx. 4 Nm) (Fig. 8).
INFORMATION
If
• the AXON Tube Adapter is shortened excessively,
• the foot is replaced by a foot with a lower system height,
• a shorter AXON Tube Adapter is used in the event of a service joint
intermediate adapters (e.g. 4R84) are used to compensate for the height difference.
If you do so, the knee axis-ankle adapter distance must be re-entered in the software.
In general, the AXON Tube Adapter should be left as long as possible.

17
3.3 Starting the Program
There are three ways to start X-Soft:
• "Start" command in the File menu
• Click in the Windows® system menu
• Key combination Alt +F4.
1. To start X-Soft click the "New task" tab.
2. To start X-Soft, click the "X-Soft" software in the "New task" tab.
Entering the password for the rst time
The password entry prompt is displayed after you start X-Soft. When entering the password for the rst time, you must
enter the Unlock-PIN, which was distributed as part of training on the 3B5-X2 / 3B5-X2=ST Knee Joint.
After entering the Unlock-PIN, you will be asked to enter and conrm 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 conrm a personal password
(chosen by you).

18
3.4 Closing the Program
There are three ways of closing X-Soft:
• "Exit" command in the "File" menu
• Click in the Windows® system menu
• Key combination Alt + F4.
3.5 Establish connection between the 3B5-X2/3B5-X2=ST Knee Joint and X-Soft
INFORMATION
Ensure that BionicLink PC 60X5 is installed and connected to the PC used.
1. Click the Connection tab to establish a Bluetooth® connection between X-Soft and the 3B5-X2 / 3B5-X2=ST Knee
Joint. To select the last knee joint connected, select the Prioritise last knee joint used checkbox.
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. Click the OK button in the pop-up window to establish the Bluetooth® connec-
tion between X-Soft and the selected 3B5-X2 / 3B5-X2=ST Knee Joint.

19
If a connection exists, then the name of the knee joint is displayed and the connection icon is displayed at the top of
the window in green.
The knee joint emits brief beep and vibration signals to indicate to the patient and prosthetist that settings can now
be made.
After a connection has been successfully established, the data is imported from the knee joint and copied to the cor-
responding elds 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.
The prosthesis should not be removed from range while a connection is established.
INFORMATION
If the knee joint is in a safety mode (charger connected, tube adapter disconnected or due to a malfunction), certain
functions cannot be performed during the adjustment process (blocking the knee joint for static alignment, switching
to the MyModes). Safety mode of the knee joint is indicated at the top right of the display.

20
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. This may subsequently cause the patient to fall.
Always enter the weight in the unit set. Ensure that the two dimensions required are selected and entered correctly.