Otto Bock Genium X3 User manual

Genium X3 - Bionic Prosthetic System
Instructions for Use (Qualified Personnel)..................................................................... 3

Genium X3 - Bionic Prosthetic System Ottobock | 3
Adapter
Inductive Charger/
AC Adapter
Knee Joint / Remote Control
Protector/Flexion stops
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
2R19
4R119
1C60
1E56 1E57
1C61 1C62
4E60
4X193
4X194
Wristband
not illustrated
with Screw Top
3B5-X3=ST
with Pyramid Adapter
3B5-X3
4X350-X3
1C30/1C31 1C40
1M10 1D35
1C63 (*) 1C64
757L16-*
4H102 4H101
(*) In combination with this knee joint, the 1C63 Triton Low Profile in foot size 29 cm and 30 cm is approved for a maximum body weight of 125kg/275 lbs

Genium X3 - Bionic Prosthetic System4 | Ottobock
1 Intended Use .....................................................................................................................................6
1.1 Medical Purpose .............................................................................................................. 6
1.2 Field of Application ........................................................................................................... 6
1.3 Conditions of Use ............................................................................................................. 7
1.4 Qualifications ................................................................................................................... 7
1.4.1 Qualifications of the Prosthetist ....................................................................................... 7
1.4.2 Qualifications of the Therapist and Nursing Staff ................................................................ 7
1.5 Functions ........................................................................................................................ 7
1.6 Safety Instructions ............................................................................................................ 7
1.7 Scope of Delivery ............................................................................................................. 7
1.8 Recommended Accessories ............................................................................................... 7
1.9 General Safety Instructions ................................................................................................ 8
1.10 Patient Information .......................................................................................................... 9
1.11 Installation of X-Soft .......................................................................................................12
2 Alignment and Adjustment of the Prosthesis .............................................................................12
2.1 Charging the knee joint ....................................................................................................12
2.2 Connecting the AXON Tube Adapter .................................................................................14
3 Torque values of the screw connections .....................................................................................16
3.1 Configuring Control of the Prosthesis via X-Soft ..................................................................16
3.1.1 Running function in Basic Mode .....................................................................................16
3.1.2 Running mode as specific MyMode .................................................................................16
4 4H101/4H102 Flexion stops ..........................................................................................................17
5 MyMode Motion Switching ...........................................................................................................18
5.1 Switching to MyModes without a remote control ..................................................................18
6 Remote control ...............................................................................................................................19
6.1 Introduction ....................................................................................................................19
6.2 Control Elements of the remote control ...............................................................................20
6.3 Initial Connection between the remote control and the knee joint (Pairing) ..............................20
6.4 Status Bar ......................................................................................................................20
6.5 MyMode Switching via remote control ................................................................................21
6.6 Changing Prosthesis Settings ...........................................................................................21
6.7 Deep Sleep Mode ............................................................................................................22
6.8 Querying the Prosthesis Status .........................................................................................23
Table of Contents
INFORMATION
Last update: 16 October 2013
• Please read this document carefully.
• Follow the safety instructions and the stated precautions in this accompanying document.
• If assistance is required during the start-up, use or maintenance of the product, as well as in the event of
unexpected operating behaviour or circumstances, contact the manufacturer (see manufacturer‘s address
on the back of this accompanying document).

Genium X3 - Bionic Prosthetic System Ottobock | 5
6.9 Mute mode .....................................................................................................................24
6.10 Remote control Adjustments ............................................................................................24
6.11 Managing Prosthesis ......................................................................................................25
6.12 Connecting to the Prosthesis during Normal Operation ......................................................25
6.13 Charging the remote control ............................................................................................26
6.14 Completing the Fitting ....................................................................................................26
7 Important Information for Patients ..............................................................................................27
7.1 Safety Messages and Safety Modes ...................................................................................27
7.2 Charging Status ..............................................................................................................29
7.3 Storage and Ventilation .....................................................................................................29
7.4 Cleaning and Care ..........................................................................................................29
7.5 Service ...........................................................................................................................29
7.6 Warranty .........................................................................................................................30
7.7 Technical Information .......................................................................................................30
7.7.1 General Information ......................................................................................................30
7.7.2 Knee joints ...................................................................................................................30
7.7.3 AXON Tube Adapter ......................................................................................................31
7.8 Symbols on the knee joint .................................................................................................31
7.9 Symbols on the remote control ..........................................................................................31
7.10 Symbols on the Inductive Charger ...................................................................................32
8 Definition of Terms .........................................................................................................................32
9 Liability ............................................................................................................................................34
10 Trademarks ...................................................................................................................................34
11 CE Conformity ...............................................................................................................................34

Intended Use
Genium X3 - Bionic Prosthetic System6 | Ottobock
Explanation of symbols in the instructions for use
DANGER Warnings regarding directly impending risks of severe accident or injury.
WARNING Warnings regarding possible risks of severe accident or injury.
CAUTION Warnings regarding possible risks of accident or injury.
NOTICE Warnings regarding possible technical damage.
1 Intended Use
INFORMATION
Read these instructions carefully before using the 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 following
sections: 1.3 Conditions of Use, 1.5 Functions, 1.6 Safety Instructions, 2.1 Charging the knee joint, 5MyMode
Motion Switching, 6 remote control, 7 Important Information for Patients, 9 Liability
Only start up the product in accordance with the information contained in the accompanying documents supplied.
Instruct the patient in the proper use and care of the product. The product may not be transferred to the patient
without prior instruction.
1.1 Medical Purpose
The knee joint is to be used exclusively for exoprosthetic fittings of the lower extremity.
1.2 Field of Application
The Genium X3 was designed for broad field of application and can be used by transfemoral amputees as well
as by active hip disarticulation amputees. For knee disarticulation amputees, a version for long residual limbs is
available (3B5-X3=ST).
The patient must fulfill the following requirements:
• The patient must fulfill the physical and mental requirements for the perception of audible signals and/or me-
chanical vibrations.
• The skin on the residual limb must be completely healed.
• The knee pivot point-ground measurement must be at least 318 mm (if 2R19 is used). The minimum distal
system height (distance between the knee axis and the centre point of the lower pyramid adapter on the AXON
Tube Adapter) of the knee joint with a AXON Tube Adapter must be 310mm.
• Hip disarticulation and / or hemipelvectomy patients must be fitted with the 7E10=* Helix3D Hip Joint.
INFORMATION
Advise your patients of the information in this section.
Application according to the Ottobock MOBIS Mobility System:
Recommended for mobility grades 3 and 4 (restricted outdoor walkers, unrestricted outdoor
walkers and unrestricted outdoor walkers with especially high requirements).
Approved for body weights of up to 125 kg (275 lbs).

Intended Use
Genium X3 - Bionic Prosthetic System Ottobock | 7
1.3 Conditions of Use
INFORMATION
Advise your patients of the information in this section.
The knee joint was developed for everyday activities. Misuse and abuse is not covered under warranty. See Sec-
tion 7.7 “Technical Information“ for the permitted ambient conditions. The Genium X3 System is designed exclu-
sively for use on one patient. Use of the product by other persons is not approved by the manufacturer.
1.4 Qualifications
1.4.1 Qualifications of the Prosthetist
Only prosthetists who have been authorised by Ottobock after completing a corresponding training course may
fit patients with the knee joint.
1.4.2 Qualifications of the Therapist and Nursing Staff
The therapists or nursing staff must be trained in handling the knee joint (and accessories) by the authorised
prosthetist.
1.5 Functions
The knee joint is a electronic knee joint system with hydraulic stance and swing phase control. Microprocessor-
controlled hydraulics dynamically adapt the system in real time. The control mechanism is realised by means of a
sensor system, which captures the measurements every 0.01 seconds (corresponds to 100 Hz). By evaluating the
measurements, the knee joint recognises the current gait phase of the prosthesis wearer. This allows the Genium
X3 to adapt in real time to the individual requirements and the activities of the prosthesis wearer. Additional my
modes permit activities such as cycling, cross-country skiing or inline skating.
1.6 Safety Instructions
INFORMATION
Advise your patients of the information in this section.
CAUTION
Non-observance of safety instructions. Failure to observe the safety instructions and precautions described
in this accompanying document can lead to faulty control or malfunction of the product and may result in risk of
injury for the patient as well as destruction of the product.
1.7 Scope of Delivery
1 pc. 3B5-X3/3B5-X3=ST Genium X3 - Bionic Prosthetic System
1 pc. 4X350-X3 Remote control
1 pc. 757L16-* AC Adapter
1 pc. 4E60 Inductive Charger
1 pc. 4H101 Flexion stop
1 pc. 4H102 Flexion stop (when delivered the knee joint is equipped with the 4H102 flexion stop)
1 pc. 4X194 Protector
1.8 Recommended Accessories
1 pc. 2R19 AXON Tube Adapter
1 pc. 4X1=* X-Soft

Intended Use
Genium X3 - Bionic Prosthetic System8 | Ottobock
1.9 General Safety Instructions
CAUTION
Alignment and adjustment errors. When fitting and adjusting the prosthesis, errors can occur, which can
cause malfunctions of the knee joint including loss of function due to structural failure. This may cause the pa-
tient to fall.
• Participation in an Ottobock product training course for the knee joint is mandatory prior to the first fitting.
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 fitting. 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 incorrect time.
CAUTION
Use of unsuitable prosthetic components. If unsuitable prosthetic components are installed in the prosthe-
sis, malfunction of the joint and a loss of functionality due to structural failure may occur. This may cause the
patient to fall.
Only combine the knee joint with adapters and feet tested by Ottobock (see system overview, front).
Ensure that the waterproofness and corrosion resistance of every single prosthetic component is considered
individually.
Ottobock assumes no liability if the knee joint is used with components other than those specified (see system
overview, front).
CAUTION
Manipulation of system components. Independent changes and / or modifications of system components
may lead to malfunction of the knee joint and a loss of functionality due to structural failure. This may cause the
patient to fall.
• Any changes or modifications to the knee joint may limit its use.
• The knee joint may only be opened and repaired by authorised Ottobock technicians and the battery may
only be handled by Ottobock Service Centres (no independent battery replacement).
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 may cause the patient to fall.
The patient must be instructed in how to handle the knee joint properly and be informed of the patient instruc-
tions below.
CAUTION
Improper use of the remote control. Improper use may damage the remote control. This can lead to malfunc-
tion of the remote control and result in unexpected actions of the knee joint. This may cause the patient to fall.
Instruct the patient in how to use the remote control correctly based on the patient information (646D564). Ad-
vise the patient of the following patient instructions.
CAUTION
MyMode switching via remote control. When the remote control is used for MyMode switching, the damping
properties of the knee joint are changed. In certain situations (e.g. under flexion load in cycling mode), this may
cause the patient to fall.
Instruct the patient in how to use MyMode switching in MyModes based on the patient information (646D564).
Advise the patient of the following patient instructions.

Intended Use
Genium X3 - Bionic Prosthetic System Ottobock | 9
CAUTION
Transport damage. Mechanical impacts or stress during transportation of the knee joint such as shocks and
vibrations can lead to:
• Defects and resulting knee joint malfunctions.
• Battery and hydraulic unit defects, resulting in leaks.
• Loss of functionality due to structural failure.
This may cause the patient to fall and can result in skin irritation.
Use the original packaging when transporting the knee joint.
CAUTION
Consequences of product deterioration. Wear and tear on system components can lead to malfunctions of
the knee joint. This may cause the patient to fall.
In the interest of patient safety and in order to maintain reliability and protect the warranty, the specified service
intervals must be observed.
1.10 Patient Information
CAUTION
Magnetic interference. The knee joint can malfunction when near high-voltage power lines, transmitters,
transformers, CT scanners or other sources of strong electromagnetic radiation (such as security systems for
goods in deapartment stores or body scanners in airport areas). This may cause the patient to fall.
Avoid proximity to strong sources of magnetic and electric interference (e.g. transformer stations, transmitters).
If this can not be avoided, make sure to go or to stand securely (e.g. by means of handrail or the support of a
person).
CAUTION
Thermal overloading. Extended exposure to high temperatures can lead to defects and result in malfunctions
of the knee joint with a loss of functionality due to structural failure. This may cause the patient to fall.
Avoid areas with extreme temperatures (see Section 7.7 “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 malfunctions of the knee joint
• Defects of the battery and the hydraulic unit, resulting in leaks
• Loss of functionality due to structural failure
This may cause the patient to fall and can result in skin irritation.
Do not expose system components to mechanical vibrations or shocks.

Intended Use
Genium X3 - Bionic Prosthetic System10 | Ottobock
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 malfunctions of the knee joint.
• Hydraulic unit defects with an associated leakage of fluid or a loss of functionality due to structural failure.
This may cause the patient to fall and/or result in skin irritation.
• Ensure that no particles can penetrate the system components.
• The knee joint and the AXON tube adapter are waterproof. They must not be used under extreme conditions
like diving or jumping into the water and are not intended to be used under water permanently.
• After using the knee joint in a salt water environment, remove the protector, rinse knee joint and protector
with fresh water and let them dry.
• Should the knee joint come into contact with solutions other than fresh or salt water, it must be rinsed with
fresh water immediately (also see Section 7.4, Cleaning and Care).
• The knee joint is not resistant against penetration with water jets or steam.
• If there is a water leakage into the electronic system, the knee joint must be sent to an authorised Ottobock
Service Centre 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
• Battery and hydraulic unit defects resulting in leaks
This may cause the patient to fall and can result in skin irritation.
The knee joint was developed for everyday use. Misuse and abuse is not covered under warranty.
Careful handling of the prosthesis and its components not only increases their service life but, above all, ensu-
res 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 Ottobock Service.
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
• Hydraulic unit defects and resulting leaks
This may cause the patient to fall and can 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 ele-
ment and, in extreme cases, of damage to the knee joint. The knee joint should be brought to an authorised
Ottobock Service Centre 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 signal sounds, stop descending immediately and check whether stance phase control is active
(see Section 7, “Important Information for Patients“).
• Observe the vibration and audible signals (beeps) of the knee joint.
• Particular caution is required when carrying children down stairs.

Intended Use
Genium X3 - Bionic Prosthetic System Ottobock | 11
CAUTION
Improper MyMode switching. In case of improper MyMode switching into basic mode or vice versa, there is
a risk of falling (see Section 6.5 MyMode Switching via remote control)!
• After switching to a MyMode, verify the function since you may have activated a MyMode other than the
intended one (see Section 5 “MyMode Motion Switching“ and Section 6.5 “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
changing the damping behaviour of the knee joint. In certain situations, this may cause the patient to fall.
If you inadvertently selected the wrong action with the remote control (vibration or audible signal), take the load
off the knee joint and correct the command.
CAUTION
Consequences of product deterioration. Wear and tear on system components can lead to malfunctions of
the knee joint. This may cause the patient to fall.
For your own safety and to maintain operational safety and protect the warranty, comply with the specified ser-
vice and inspection intervals.
WARNING
Danger of accidents when operating 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 fitting (amputation height, uni-
lateral or bilateral, residual limb conditions, design of the prosthesis) and the individual abilities of the leg pros-
thesis 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, Ottobock recommends that vehicles should be professionally retrofitted to
meet each prothesis wearer's individual needs (e.g. automatic transmission). Risk-free driving must be ensured
even when the leg prosthesis is not functioning.
CAUTION
Malfunction of the knee joint. Malfunctions of the knee joint can lead to falling.
Observe the vibration signals and audible warnings (beep signals) of the knee joint.
INFORMATION
When using exoprosthetic knee joints, servomotor, hydraulic, pneumatic or brake load dependent control func-
tions can cause movement noise. This kind of noise is normal and inevitable. Usually, it does not cause any
problems.
If movement noise increases noticeably during the lifecycle of the the knee joint, the knee joint should be ins-
pected 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 knee joint can no longer be set to safety mode, the patient may have to actively secure the knee joint with
the residual limb musculature upon heel strike until reaching a prosthetist and/or replacing the prosthesis; the
patient should visit a prosthetist 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.

Alignment and Adjustment of the Prosthesis
Genium X3 - Bionic Prosthetic System12 | Ottobock
CAUTION
Distance to HF communication devices is too small (e.g. mobile phones, Bluetooth devices, WiFi de-
vices). Unexpected prosthesis behaviour due to interference with internal data communication. In certain situ-
ations, this can cause the user to fall.
Therefore, maintain the following minimum distance from these HF communication devices:
• Mobile phone GSM 850/GSM 900: 0.99 m
• Mobile phone GSM 1800/GSM 1900/UMTS: 0.7 m
• DECT cordless phones incl. base station: 0.35 m
• WiFi (routers, access points,…): 0.22 m
• Bluetooth devices (third-party products not approved by Ottobock): 0.22 m
1.11 Installation of X-Soft
To install and register X-Soft, please refer to the X-Soft Instructions for use 647G819.
2 Alignment and Adjustment of the Prosthesis
2.1 Charging the knee joint
INFORMATION
Advise your patients of the information in this section.
INFORMATION
Charging the knee completely before use is strongly recommended.
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.
CAUTION
Charging the prosthesis without taking it off. During charging of the prosthesis the damping characteristics
of the knee joint change because the adjustable safety mode is activated. In certain situations, this can cause
the user to fall. For safety reasons, take the prosthesis off before charging the battery.
1 2a 2b 3
1. Connect the power cord to the charger with correct polarity (Fig. 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. 2a/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 knee joint performs a self-test
and is then ready for operation, provided it is connected to the 2R19 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 Ottobock Service Centre.

Alignment and Adjustment of the Prosthesis
Genium X3 - Bionic Prosthetic System Ottobock | 13
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 rectified by connecting and removing the charger.
INFORMATION
Charging is no longer possible when the distance between the transmitter and receiver is greater than 2 mm.
However, charging should not be a problem if there is a sock or Superskin between transmitter and receiver of
the charger. (See also the charging process table).
Charging process:
LEDs 0 1 2 3 4 5
Charging
status
0%-10% 10%-30% 30%-50% 50%-70% 70%-90% >90%
Charging process table:
Status Status LED Charging status indicator
AC Adapter is connected, but the
charger is not connected to the
knee joint.
Continuous green All five LEDs off
Charger connected to knee joint Purple pulsing (4-second-
sond cycle)
*
Charging status indicator (green)
according to the number of LEDs lit
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 2.1, Fig. 3)
Charger fault (error may be rectified
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 approximately one minute to avoid bothersome light at night. The char-
ging 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 patient by knee joint vibration signals once the remai-
ning battery capacity reaches approximately 25% (see table below).
vibration signal of the knee joint Charging status Remaining operating time
3 x vibration 25 % approx. 24 h
5 x vibration 10 % approx. 6 h
10 x vibration and beeping 5 % 0 h
INFORMATION
When the knee joint is fully charged (all 5 LEDs at the side light up (Fig. 3)), the maximum period of use for the
knee joint before the next charging process is up to 5 days, depending on patient activity. However, we recom-
mend charging the knee joint every night.

Alignment and Adjustment of the Prosthesis
Genium X3 - Bionic Prosthetic System14 | Ottobock
CAUTION
Feedback is disabled in mute mode. When the mute mode is active, all vibration and beep signals are di-
sabled and the knee joint will go into low battery mode without any warning! If unexpected, this can cause the
patient to fall. Be aware of this fact before activating the mute mode.
2.2 Connecting the AXON Tube Adapter
4
1 2 3
1. Determine the required length of 2R19 AXON Tube Adapter with the configuration software X-Soft.
2. Shorten the AXON Tube Adapter to the determined value with the 719R3 AXON 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.
3. Finally, the plug cover must be removed.
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 may cause the patient to fall.
Ensure the cable is not damaged.
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 connecting and removing the charger, it returns to normal mode.
INFORMATION
If the knee head is fully flexed while the joint is standing upright, the joint switches to sitting or energy-saving
mode after 2 seconds. Then the tube adapter can be disconnected without triggering an error message. Ensure
that there is no active Bluetooth connection.
This function can be used for storage, shipping or to replace tube adapters.
4. 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. 4Nm). Fit the AXON Tube Adapter to the foot such that the printed scale
faces the front (Fig. 3).
5. Attach the cable of the AXON Tube Adapter to the cable of the knee joint (Fig. 4).

Alignment and Adjustment of the Prosthesis
Genium X3 - Bionic Prosthetic System Ottobock | 15
5678
6. 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.
7. Push the AXON Tube Adapter 60 mm into the 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, a
loss of functionality due to structural failure can result. This may 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 body weight is supported on the prosthesis after adjusting the length, the
screws on the tube clamp of the knee joint must first be tightened to the prescribed torque values.
8. Turn the foot outwards slightly, and tighten both screws on the terminal clamp slightly using an Allen key (size
4 mm) (approx. 4Nm) (Fig. 8).
INFORMATION
If
• the AXON Tube Adapter is shortened excessively,
• the foot has been replaced with a foot with insufficient 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 this is the case, 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.

Torque values of the screw connections
Genium X3 - Bionic Prosthetic System16 | Ottobock
3 Torque values of the screw connections
CAUTION
Failure to comply with torque values. Failure to comply with the torque values of the screw connections can
lead to a loss of functionality due to structural failure. This may cause the patient to fall.
Compliance with the specified torque values is essential in order to ensure operational reliability.
15 Nm
1
7 Nm
2
15 Nm
3
Use a 710D4 Torque Wrench with a 710Y2=4 Hex Bit to tighten the screws alternately, in several steps increasing
the torque slowly, until the prescribed torque is reached:
1. Tube adapter: 15 Nm
2. Clamp: 7 Nm
3. Fitting for short residual limb
4. When using a rotation adapter or sliding adapter: 15 Nm
3.1 Configuring Control of the Prosthesis via X-Soft
To configure the prosthesis, please refer to the X-Soft Instructions for use 647G819.
In addition to all functions described in the X-Soft instructions, the knee joint offers a running function.
3.1.1 Running function in Basic Mode
The knee joint detects a transition from walking to running in Basic mode, and reacts accordingly. The knee
automatically provides a larger swing flexion angle appropriate for running and zero preflex angle for heel strike.
When in Basic mode, the patient has to initiate the running function actively. To initiate a running step it is best to
exaggerate the loading of the prosthesis for the first steps until a steady running state is reached. This exaggera-
tion triggers the running function. It takes a little training, until the patient can use the Running function in Basic
mode.
3.1.2 Running mode as specific MyMode
Additionally, there is a dedicated running mode available, that can be configured as a MyMode. In this mode,
every step will be performed as a running step with larger swing angle and no preflex.
INFORMATION
The running function will work with specialized running feet such as the 1E90 Sprinter as well as with prosthe-
tic feet with axial compression such as the 1C61 Triton Vertical Shock. For details on assembly and alignment
please refer to the Instructions for Use of the foot.
Feet without axial compression are generally not suited for running.

4H101/4H102 Flexion stops
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4 4H101/4H102 Flexion stops
CAUTION
Errors in prosthesis alignment. Errors made during the alignment of the prosthesis can damage the hydraulic
unit of the joint. A defective hydraulic unit can lead to joint malfunction up to loss of function due to structural
failure. This can cause the patient to fall. The hydraulic unit may be destroyed if it comes into contact with the
socket! At maximum flexion, it is essential to maintain a minimum distance of 3 mm (1/8“) between the hydraulic
unit and the socket. At maximum flexion, the knee joint must be equipped with a flexion stop if contact with the
frame of the knee joint cannot be avoided (voluminous residual limbs).
1
4H102
15° 2
4H101
7,5° 3
When delivered, the knee joint is equipped with the 4H102 Flexion Stop, which reduces the maximum flexion
angle by 15°, thus preventing contact with the hydraulic unit. It is also possible to equip the knee joint with the
smaller 4H101 Flexion Stop, which reduces the flexion angle by 7.5°.
INFORMATION
If no flexion stop is desired, the knee joint can also be used without a flexion stop (the screws are removed to-
gether with the flexion stop). In this case, it must be ensured that the socket and the hydraulic unit do not collide.
To switch to the smaller 4H101 Flexion Stop:
12
1. Loosen the screws with the 710H5=1 Screwdriver (Fig. 1).
2. Remove the 4H102 Flexion Stop and insert the 4H101 Flexion Stop (Fig. 2).
3. Clean the screw thread with a brush. Apply Loctite 243 onto the screw thread and tighten the screws (Phillips
Recess size 1) with a dynamometric key with 60 NM.

MyMode Motion Switching
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5 MyMode Motion Switching
INFORMATION
Advise your patients of the information in this section.
5.1 Switching to MyModes without a remote control
If switching by bouncing up and down has been activated in X-Soft, you can switch without a remote control by
bouncing up and down on the forefoot three times in a second, with the foot remaining in contact with the ground
at all times and the prosthetic leg extended. While doing so, the forefoot has to bear approximately 40% of the
total body weight at peak load and less than approximately 25% of the body weight at the lowest load. However,
the load may not be taken off the foot fully.
1 2 3
1 second
3 ×
in 1 second
After the audible signal sounds (one long beep and a long vibration signal), your weight must be taken off the
prosthesis entirely for at least one second with the knee extended (no ground contact). Then the knee joint swit-
ches to the first MyMode and emits two short Beep and vibration signals.
The procedure for switching to the second MyMode is the same, except for bouncing up and down four times. In
this case, the switch is indicated by three short Beep and vibration signals.
Bouncing at least three times to return to basic mode from any MyMode. The switch is confirmed by a short Beep
and vibration signal
If only triple bouncing is activated but quadruple bouncing is not, you can access the first MyMode via any number
of bouncing motions greater or equal to 3.
INFORMATION
Switching back to basic mode by bouncing up and down three or more times cannot be deactivated. Thus, you
can access basic mode even if switching via bouncing is not enabled in X-Soft.
INFORMATION
Returning to basic mode is also possible by connecting the battery charger.
CAUTION
Feedback is disabled in mute mode. When the mute mode is active, no feedback will be given when swit-
ching into a MyMode or back to basic mode. If switching was unsuccessful, the behaviour of the knee joint may
be unexpected.
This may result in a risk of falling. Make sure that the switching process has been successful before continuing
to use the knee joint.

Remote control
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6 Remote control
6.1 Introduction
INFORMATION
Advise your patients of the information in this section.
The knee joint can be used in normal operation in basic mode (incl. optional Intuitive Stance function, Sitting
function, Stairs and Obstacles function and OPG function) and in up to five different MyModes. The MyModes
can be activated using the remote control.
Basic mode is used on a day-to-day basis, while the MyModes are pre-programmed for specific movements and
/ or postures such as standing at a workbench, cycling, inline skating or cross-country skiing.
X-Soft is used to configure which MyModes are used as well as their settings. However, some parameters can
also be adjusted with the remote control.
CAUTION
Improper MyMode switching using the remote control. MyMode switching using the remote control chan-
ges the damping behaviour of the knee joint. In certain situations, this may cause the patient to fall.
The patient must stand securely when switching between modes and must carefully confirm whether the desi-
red function was successfully set by the knee joint.
CAUTION
Penetration of water into the remote control. The remote control is not waterproof. Under ambient condi-
tions where the remote control may get wet, using the supplied 4X194 Arm Band for protection is recommen-
ded. If water penetrates the remote control, the device may be damaged. This can lead to malfunctions of the
remote control, result in unexpected actions of the knee joint and cause the patient to fall.
Should the remote control accidentally come into contact with water then be dried at room temperature for at
least 1 day. Before using the remote control again, send it to an authorised Ottobock Service Centre.
CAUTION
Manipulation on the remote control . Any unauthorised changes or modifications you make to the remote control
can lead to malfunctions and result in unexpected actions of the knee joint. This may cause the patient to fall.
Any changes or modifications to the device may limit its usability.
CAUTION
Unauthorised connection. If an unauthorised connection between a remote control and a knee joint is estab-
lished, the knee joint can react unexpectedly. This may cause the patient to fall. Pairing between the knee joint
and the remote control does not require any password or acknowledgment from the knee joint. It is therefore
theoretically possible (with known serial number of the knee joint or if only one knee joint is within range of the
remote control), that a third party performs pairing with the knee joint and changes settings or switches MyMo-
des.
INFORMATION
The knee joint should consciously be kept still during the switching process.
INFORMATION
For safety reasons, the remote control automatically turns off after two minutes. After the remote control is tur-
ned on, approximately three seconds may elapse before it is ready for mode switching processes.
INFORMATION
The range of the remote control is max. 5 meter.

Remote control
Genium X3 - Bionic Prosthetic System20 | Ottobock
6.2 Control Elements of the remote control
INFORMATION
Advise your patients of the information in this section.
1
3
4
3
2
1. LCD screen.
2. Enter button.
3. Navigation buttons: left, right, up, down.
4. Charging receptacle.
6.3 Initial Connection between the remote control and the knee joint (Pairing)
1. Press the enter button to activate the remote control. The start-up screen with the date, time and charging
state of the remote control is displayed. Without additional input, the remote control turns off automatically
after 5seconds.
2. Press to attempt to connect the device. The remote control searches for active prostheses.
3. When a knee joint is found (serial number is shown), press enter to confirm. If several knee joints are found,
the serial number of the desired knee joint has to be selected using the navigation keys (display: serial num-
ber). The configuration data from the knee joint is then loaded.
INFORMATION
This process can take a few minutes.
4. The main menu is displayed.
After successful initial connection with the knee joint, the remote control always connects automatically after acti-
vation (press the enter button first, then ). No further steps are required.
6.4 Status Bar
The status bar shows:
1. Charging state of the remote control
2. Charging state of the knee joint with percentage indicator
3. Current MyMode
4. In case of a deviation from normal knee joint functionality
(e.g. when the charger is connected), an exclamation mark
is shown in the status bar at the top right. The current My-
Mode is not displayed in some of these situations.