ottobock Genium X4 Microprocessor

Specifications

• Product Name: Genium X4 3B5-4=P, 3B5-4=ST
• Design: Knee head with proximal connection (pyramid for 3B5-4=P or screw thread for 3B5-4=ST)

Product Usage Instructions

Switching the Product On/Off
To switch the product on/off, follow the steps outlined in the user manual. Typically, there will be a power button or switch located on the device that needs to be pressed or toggled to turn the product on or off.

Establishing the Bluetooth Connection
If your Genium X4 3B5-4=P, 3B5-4=ST supports Bluetooth connectivity, you can establish a connection by navigating to the  Bluetooth settings on your device and searching for the product. Follow the on-screen instructions to pair the devices.

Storage
When not in use, store the product in a cool, dry place away from direct sunlight and moisture. Avoid exposing the product to extreme temperatures or humidity levels.

Maintenance
Regular maintenance is essential to ensure the product functions properly. Refer to the maintenance section in the user manual for detailed instructions on how to clean and care for your Genium X4 3B5-4=P, 3B5-4=ST.

Technical Data
Refer to the technical data section in the user manual for detailed specifications and information about the product’s performance, battery life, and other technical details.

FAQ
Q: How do I know when the battery needs to be charged?
A: The LED bar on the charging adapter will indicate the charge level while charging. Additionally, there is a temperature warning for the battery in the prosthetic knee joint that alerts you when the battery needs attention.

Foreword

INFORMATION

Date of last update: 2024-05-15

• Please read this document carefully before using the product and observe the safety notices.
• Instruct the user in the safe use of the product.
• Please contact the manufacturer if you have questions about the product or in case of problems.
• Report any serious incident related to the product, in particular any deterioration of health, to the manufacturer and the competent authority in your country.
• The product “Genium X4 3B5-4=*“ is called the product/prosthesis/knee joint/component in the following.
• The product “USB charging adapter 757L47=1” is referred to as the charging adapter below.
• These instructions for use provide you with important information on the use, adaptation and handling of the product.
• Only put the product into use in accordance with the information contained in the accompanying documents supplied.
• According to the manufacturer (Otto Bock Healthcare Products GmbH), the patient is the operator of the product according to the IEC 60601-1:2005/A2:2020 standard.

Product description

Design
The product consists of the following components:

1. Knee head with proximal connection (pyramid for 3B5-4=P or screw thread for 3B5-4=ST)
2. Flexion stop (15°, pre-installed)
3. Hydraulic unit
4. Status indicator of the knee joint (see page 29)
5. LED as indicator for the Bluetooth connection (see page 30)
6. Charging receptacle
7. Distal tube clamp screws

Charging adapter

1. Cable for connecting to the charging receptacle of the prosthetic knee joint
2. LED bar to indicate the charge level while charging (see page 33)
3. Light sensor for adjusting the LED brightness to the ambient light
4. Temperature warning for the battery in the prosthetic knee joint (see page 33)
5. Maintenance indicator (see page 33)
6. Status indicator of the charging adapter (see page 33)
7. USB-C bushing for connecting the power supply or a USB power source using the USB type C to USB type A connection cable (included in the scope of delivery)

Function

• This product features microprocessor control of the stance and swing phase.
• The microprocessor uses the measurements of an integrated sensor system as a basis to control a hydraulic unit that influences the damping behaviour of the product.
• These sensor data are updated and evaluated 100 times per second. As a result, the behaviour of the product is adapted to the current motion situation (gait phase) dynamically and in real time.
• The product can be individually adapted to the needs of the patient with the “560X29-*=* connectgo.pro” adjust­ment app.
• The product features MyModes for special motion types (e.g. golf, table tennis, etc.). These are pre-configured using the adjustment app and can be activated with special movement patterns and the Cockpit app (see page 20).
• In case of an error in the sensor system, hydraulic control or when the battery is empty, safety mode provides restricted function and makes safe walking possible. Resistances that are predefined by the product are con­figured for this purpose (see page 22).
• The Cockpit app makes it possible to switch between preconfigured MyModes and to change the product beha­viour to a certain extent (e.g. while becoming accustomed to the product). In addition, information about the product (step counter, charge level, etc.) can be retrieved.
• With the USB charging adapter, it is possible to charge the knee joint using a mobile power source while out and about (see the section “Charging the battery” see page 10).
• The microprocessor-controlled hydraulic unit offers the following advantages
• Approximation of the physiological gait pattern
• Stability while standing and walking
• Adaptation of product characteristics to various surfaces, inclines, gait situations and walking speeds
• Automatic detection of cycling without additional switching (see page 19)
• Walking backwards safely without switching to the swing phase

Essential performance of the product

• Stability in the stance phase
• Initiating the swing phase
• Extension and flexion resistances set automatically by swing phase control

Combination possibilities
This product can be combined with the following Ottobock components:

Prosthetic hip joints

• 7E9 Monocentric prosthetic hip joint Adapters
• 4R104=60 double adapter, sliding
• 4R104=75 double adapter, sliding
• 7E10 Helix3D prosthetic hip joint
• 4R57, 4R57=ST Rotation adapter (not waterproof, not corrosion-resistant)
• 4R57=WR, 4R57=WR-ST Rotation adapter (water­proof, corrosion-resistant)
• 4R41 lamination anchor with pyramid receiver
• 4R43 lamination anchor with threaded connector
• 4R47=* Refit adapter for lamination anchor
• 4R48=* Refit socket adapter
• 4R89 lamination anchor with pyramid adapter
• 4R111=N lamination anchor with threaded connect­or
• 4R111 lamination anchor with pyramid receiver
• 4R116 lamination anchor with pyramid adapter
• 4R119 Lamination anchor with pyramid receiver and angled arm
• 4R40 torsion adapter
• 4R118 adapter plate
• 4R10 Quickchange

Tube adapter

• 2R68=280 Axon tube adapter (waterproof, corrosion-resistant)
• 2R69=280 Axon tube adapter with torsion unit (not waterproof, not corrosion-resistant) Prosthetic feet
• 1C10 Terion
• 1C30-1 Trias
• 1C31 Trias
• 1C40 C-Walk
• 1C50 Taleo
• 1C51 Taleo Vertical Shock
• 1C52 Taleo Harmony
• 1C53 Taleo Low Profile
• 1C56 Taleo Adjust
• 1C58 Taleo Side Flex
• 1C60 Triton
• 1C61 Triton Vertical Shock
• 1C62 Triton Harmony
• 1C63 Triton Low Profile
• 1C64 Triton Heavy Duty
• 1C68 Triton side flex
• 1C70 Evanto
• 1D35 Dynamic Motion
• 1E56 Axtion
• 1E57 Lo Rider
• 1E95 Challenger
• 1B1 Meridium
• 1B1-2 Meridium
• 1A1-2 Empower
• F11 Maverick Xtreme
• F21 Maverick Xtreme AT
• F22 Maverick Comfort AT
• F23 Maverick Vertical Shock
• LP-W2 Freestyle Swim

 Limits for combination options with prosthetic feet

1C63 Triton Low Profile

Body weight	Approved foot size [cm]
Up to 125 kg (up to 275 lbs)	21 to 30
126 kg to 150 kg (276 lbs to 330 lbs)	21 to 28

1C56 Taleo Adjust

F21 Maverik Xtreme AT

Body weight	Approved foot size [cm]	Maximum stiffness
Up to 125 kg (275 lbs)	Up to 30	9
126 kg to 150 kg (277 lbs to 330 lbs)	Up to 27	9
	Up to 28	7

FS5 Thrive

Body weight	Approved foot size [cm]	Maximum stiffness
Up to 125 kg (275 lbs)	Up to 31	9
126 kg to 150 kg (277 lbs to 330 lbs)	Up to 26	9

LP2-W2 Freestyle Swim

Body weight	Approved foot size [cm]	Maximum stiffness
Up to 100 kg (220 lbs)	Up to 31	6
101 kg to 150 kg (222 lbs to 330 lbs)	Not approved

Combination with an osseointegrated implant system

• This product can be connected to a socket or to an osseointegrated, percutaneous implant system.
• In case of connection to an implant system, verify that the manufacturer of the implant system and the manufactur­ers of the corresponding exoprosthetic components/adapters also permit this combination. It must be ensured that all indications/contraindications, the field of application, the conditions of use and all safety
• instructions are com­plied with for the implant system, corresponding exoprosthetic components, corresponding adapters and for the knee joint.
• Among other things, this relates to the body weight, mobility grade, type of activity, load capacity of the implant and bone anchoring, freedom from pain under functional load and compliance with the permissible ambient conditions (see page 25).
• Please ensure that the qualified personnel applying the product is not only authorised for fitting this knee joint, but also for the connection to the osseointegrated implant system.

Intended use

Indications for use
The product is to be used solely for lower limb exoprosthetic fittings.

Conditions of use

• The product was developed for everyday use and must not be used for unusual activities. These unusual activities include, for example, extreme sports (free climbing, parachuting, paragliding, etc.).
• Permissible ambient conditions are described in the technical data (see page 25).
• The product is intended exclusively for use on one patient. Use of the product by another person is not approved by the manufacturer.
• The MOBIS classification describes the mobility grade and body weight, and makes it easy to identify compatible components.
• Knee joint with attached 2R68=280 Axon tube adapter

The product is recommended for mobility grade 2 (restricted outdoor walker), mobility grade 3 (unrestricted outdoor walker) and mobility grade 4 (unrestricted outdoor walker with particularly high demands). Approved for a body weight of up to 150 kg (330 lbs).

Knee joint with attached 2R69=280 Axon tube adapter with torsion
The product is recommended for mobility grade 2 (restricted outdoor walker), mobility grade 3 (unrestricted outdoor walker) and mobility grade 4 (unrestricted outdoor walker with particularly high demands). Approved for a body weight of up to 125 kg (275 lbs).

Indications

• For patients with knee disarticulation, transfemoral amputation or hip disarticulation
• For unilateral or bilateral amputation
• Those affected by dysmelia, with the characteristics of the affected body part corresponding to a knee disartic­ulation, transfemoral amputation or hip disarticulation
• Osseointegration
• The patient must fulfil the physical and mental requirements for perceiving visual/acoustic signals and/or mech­anical vibrations.
• The patient must be able to understand usage and safety messages and put them into practice.

Contraindications

Absolute Contraindications

• Body weight over 150 kg

Relative Contraindications

• Body weight less than 35 kg

Qualification
The product may be fitted only by qualified personnel authorised by Ottobock after completing the corresponding training.
If the product is to be connected to an osseointegrated implant system, the qualified personnel must also be autho­rised for the connection to the osseointegrated implant system.

Safety

Ottobock developed this product according to applicable standards and rules and tested it multiple times. In order for you to enjoy the product, we need your help. Only by complying with the following instructions can we guaran­tee safe treatment and operation.

Meaning of warning levels

• WARNING! Failure to follow the instructions can lead to serious accidents and injuries.
• CAUTION! Failure to follow the instructions can lead to accidents and injuries.
• NOTICE! Failure to follow the instructions can result in technical damage.

 Before treatment
WARNING! Possibility of influences on the human body

• Observe the areas of application and operating conditions of your product in combination with osseointegrated implant systems according to the information of the manufacturer.
• Note the instructions of the clinical personnel that indicated the use of the osseointegrated implant system.

1. Slide the country-specific plug adapter onto the power supply unit until it locks into place (see fig. 1).
2. Use the provided USB cable to connect the USB-A bushing on the power supply unit to the USB-C bushing on the charging adapter (see fig. 2).
3. Plug the power supply into the outlet (see fig. 3).
   1. The status indicator on the charging adapter lights up green (see fig. 4).
   2. If the status indicator on the charging adapter does not light up, or lights up in a different colour, this indicates an error (see page 33).

Charging the prosthesis battery

1. Connect the charging plug to the charging receptacle of the product.
   INFORMATION: The charging plug is held by a magnet
   • A short vibration signal is generated and a short, soft sound (whee) is produced.
   • The status LED ( symbol) above the charging receptacle lights up yellow
   • The charging process starts.
   • The status LED ( symbol) lights up during the charging process.
   • The charging progress is indicated on the charging adapter by five green
     LEDs (see page 11).
2. Disconnect the product after the charging process is complete.
   • The status LED ( symbol) lights up green and a short, soft sound (whee) is produced.

Display of the current charge level

Illustration of the LED symbols

Display of the current charge level during the charging process
During the charging process, the current charge level is indicated by the number of LEDs lit on the charging adapter. If the LEDs do not light up or light up in a different colour, this indicates an error. For troubleshooting, see the section “LED symbols on the charging adapter” (see page 33).

The following charging times apply only when the provided power supply unit and the provided USB cable are used:

Charging time of the prosthesis battery
Charge level after 1 hour charging time	35 %
Charge level after 2 hours charging time	70 %
Charge level after 3 hours charging time	90 %

Charging time of the prosthesis battery
Charge level after 4 hours charging time	Fully charged

INFORMATION
Note charging progress

• When a rechargeable battery has been deeply discharged, charging times may become longer. For this reason, check the charge level on the charging adapter display while charging.
  If the first symbol does not light up continuously even after 8 hours , the component must be inspected by an authorised Ottobock Service Centre.

Display of battery charge level without additional devices

INFORMATION
The charge level cannot be queried during the charging process or when MyMode is activated, e.g. by turning the prosthesis over. The product is in charging mode.

1. Turn the prosthesis by 180° (the sole of the foot must face up).
   INFORMATION: It must be a complete 180° rotation as shown in the picture. A rotation from a horizontal to a vertical position (90° rotation) is not enough.
2. Hold still for 2 seconds and wait for feedback signals.

Preparing the product for use

Alignment

INFORMATION

• Do not clamp the tube adapter in a vice.
• Only shorten the tube adapter with a tube cutter.
• When shortening the tube adapter, make sure the cable does not get damaged.

Shortening the Tube Adapter

1. Screw the tube adapter (maximum length) together with the prosthetic foot.
2. Insert the tube adapter approximately 60 mm into the prosthetic knee joint.
   For use, the tube adapter must be inserted at least 40 mm into the prosthetic knee joint. Since the maximum insertion depth is 70 mm, there is 10 mm to slide the tube adapter further in, and 20 mm to pull the tube adapter further out.
3. Measure the overall size.
4. Determine the knee pivot point to ground measurement on the patient.
5. Determine the required length of the tube adapter based on the difference between the overall size and the knee pivot point to ground measurement.
6. Shorten the tube adapter by the determined value with the 719R5 tube cutter.
7. Store the tube adapter cable in the tube adapter. If this is not possible, the cable must be protected against damage.
8. Use a file (cut 2 (medium), e.g. 715H1=2 recommended) to file the cut edge smooth. Be careful of the tube adapter cable.
   NOTICE! When filing or deburring, make sure that no metal shavings can get into the plug of the tube adapter cable.
9. Bevel the outer side with a file.
10. Smooth the inside and outside of the cut edge with sandpaper (recommended grit 120).

Installing the Tube Adapter

1. Install the prosthetic foot on the tube adapter and tighten the set screws on the tube adapter to 15 Nm. INFORMATION: The printed scale on the tube adapter must face in the anterior direction.
2. Connect the cable of the tube adapter to the cable of the prosthetic knee joint.
   INFORMATION: With the 2R68=280, 2R69=280 tube adapters, the cable of the tube adapter can be shortened by disconnecting the intermediate piece (extension).
3. Push the protruding cable loop back into the tube adapter. If the tube adapter has been shortened to the min­imum length, the plug must be inserted into the cavity. The cable loop must then be stored carefully.
4. Insert the tube adapter approximately 60 mm into the prosthetic knee joint.
   INFORMATION: The tube adapter must be inserted at least 40 mm into the prosthetic knee joint. The maximum insertion depth is 70 mm.
5. ighten the two distal tube clamp screws to 7 Nm.

Adjusting the torsion moment on the 2R69=280 Axon tube adapter

INFORMATION

The marking on the hexagon socket screw must not be turned as far as the red area or beyond the red area.
The torsion moment can be adjusted with the Allen head screw in the centre of the adapter.

Increasing the torsion moment:

• Turn the mark in the centre of the torsion unit clockwise.

Decreasing the torsion moment:

• Turn the mark in the centre of the torsion unit counterclockwise.

INFORMATION
If the patient notices a sudden change in the torsion moment, check whether the mark of the Allen head screw is
still within the setting range. Correct the setting if this is not the case.

Disconnecting the tube adapter without a warning message
When the tube adapter is disconnected while the joint is switched on, a sound sequence and vibration signal are emitted. The yellow LED on the back of the knee joint flashes at the same time. In order to prevent this, either  switch the joint off (Switching off the product) or perform the following steps before disconnecting the charging adapter:

1. Connect the charging plug to the charging receptacle of the product.
2. Wait 16 seconds.
3. The tube adapter can be disconnected without generating a warning signal.
4. Connect the tube adapter before disconnecting the charging plug.

Bench Alignment
With correct bench alignment, e.g. in the PROS.A. assembly alignment apparatus (743A200), the benefits of the product are realised to best advantage. If the L.A.S.A.R. assembly alignment apparatus (743L200) is available, it can be used as well.
Alignment can also be carried out using LaserLine/plumb line.

INFORMATION

Changed position of the pyramid/threaded connector (0°)
If the fitting was modified from a previous knee joint generation such as the 3B1-2, 3B1-3, 3B5-2, 3B5-3; 3C98-*, 3C88-* to this knee joint (3B5-4=P/3B5-4=ST) without fabricating a new socket, the changed position of the pyr­amid/threaded connector has to be taken into account since the pyramid/threaded connector is no longer angled (0°). Use intermediate adapters (e.g. 4R47=*, 4R48=*) to adjust the position if necessary.

A calibrated alignment recommendation for bench alignment of the prosthesis is provided in the adjustment app for the individual conditions of the prosthesis and patient. The adjustment app must therefore be consulted for the alignment data.

The following points must be observed during alignment:

• If the static alignment is being carried out with the Ottobock PROS.A. Assembly or L.A.S.A.R. Assembly alignment apparatus, this must always be done without footwear, otherwise correct adjustment will not be possible.
• Static alignment with a laser line/plumb line must be carried out with footwear (except 1B1* Meridium), oth­erwise correct adjustment will not be possible.
• Ensure the knee joint is in full extension during bench alignment. To do so, briefly push the socket once into the fully extended position.

 Checking the clearance between the prosthetic socket and knee joint
After bench alignment or changes to the prosthesis, verify that the distance from the socket to the prosthetic knee joint is not less than the minimum under load at maximum flexion and extension. Damage to the hydraulics, frame, electronics housing etc. may occur if the distance is insufficient (flexion) or in case of contact (extension) between the socket and the prosthetic knee joint.

Verification at maximum flexion
The distances and prerequisites for the measurement differ depending on the components that are subsequently combined:

Component	Reference number	Protective component installed/not installed	Distance from socket – prosthetic knee joint under load
Prosthetic knee joint without Protective Cover, without functional cosmes­ is	3B5-4=*	–	3 mm (distance to pros­ thetic knee joint)
Prosthetic knee joint with Protective Cover, short	3B5-4=* and 4P100=7	Protective Cover installed	3 mm (distance to Pro­ tective Cover)
Prosthetic knee joint with Protective Cover, long	3B5-4=* and 4P110=7	Not relevant	3 mm (distance to pros­ thetic knee joint)
Prosthetic knee joint with functional cosmesis	3B5-4=* and 3F2=0	Functional cosmesis not installed	5 mm (distance to pros­ thetic knee joint)

1. Flex the knee joint of the prosthesis and measure the available distance (see table).
2. Then place the prosthesis on the workbench with both hands, grasp the upper area of the socket at the front and place a substantial load on the socket in the flexion direction.
3. Check the available distance between the prosthetic knee joint and socket (see table).
   INFORMATION: If the value falls short of this distance, a flexion stop has to be installed or an existing flexion stop has to be replaced with a larger flexion stop. If the largest flexion stop is already installed, please contact Ottobock Customer Service. For information on the flexion stop, see the next section.

During the fitting, verify that the distance under the user’s weight ( e.g. kneeling) is not less than the minimum. If the minimum distance is not reached (see table), the next larger flexion stop has to be used.

INFORMATION
Padding material to check the distance
Instead of using a measuring tool, a large piece of padding material (e.g. 617S3 Pedilin from Ottobock) with a thickness of 3 mm or 5 mm can be used as a distance gauge between the socket and knee joint during the test.

Verification at maximum extension

1. Position the prosthesis as illustrated.
2. Grasp the prosthetic knee joint from the front with one hand below the pivot point.
3.  Then use the other hand to pull the socket from the upper rear to the lower front.
4.  There should be no contact between the prosthetic knee joint and the socket. INFORMATION: If there is contact, an additional appropriate adapter has to be installed between the prosthetic knee joint and the socket or the socket position has to be changed by optimising the alignment.

 Flexion stop
The knee joint comes fitted with a flexion stop upon delivery. This reduces the maximum flexion angle by 15°, thereby preventing the socket from coming into contact with the hydraulics, frame, electronics housing, etc.
To limit the flexion angle, the knee joint can be equipped with the following flexion stops:

• 7.5° flexion stop (optional accessory): Maximum flexion angle 127.5°
• 15° flexion stop (already installed on delivery): Maximum flexion angle 120°
• 22.5° flexion stop (included in scope of delivery): Maximum flexion angle 112.5°
  To reach the maximum possible flexion angle of 135°, the flexion stop can be removed. Ensure that the minimum distance of 3 mm or 5 mm between the socket and the joint is maintained (see table in previous section see page 14).

Removing the flexion stop

1. Use an appropriate screwdriver to loosen the screws on the flexion stop (left and right of the piston rod).
2. Remove the flexion stop and screws from the joint.
   INFORMATION: Do not insert the screws without the flexion stop!

Insert the flexion stop

1.  Insert the flexion stop.
2. Secure the screws with 636K13 thread lock.
3. Insert the screws.
4. Tighten the screws to 0.6 Nm with the 710D21 torque wrench.

 Static alignment optimisation
The adjustment app specifies concrete reference values based on measurement data to help optimise the alignment.

Use

Consideration of the alignment recommendations for bench alignment of the prosthesis is a prerequisite. Minim­ising the compensation via the residual limb and/or the contralateral side is the goal of optimal alignment.
The patient’s required energy expenditure can be reduced by optimising the arrangement of the prosthetic compo­nents.

INFORMATION
Common causes of errors during alignment

• Foot position with excessive plantar flexion or dorsiflexion.
• Insufficient socket flexion. This has to be set according to the measured hip flexion contracture.

INFORMATION
During static alignment optimisation, the knee joint is automatically locked in the flexion direction. This should enable the patient to stand in a stable stance that is unaffected by the alignment. Patients can only walk with the prosthetic leg fully extended in this situation!

Dynamic alignment optimisation
After configuring the product with the adjustment app, dynamic optimisation during trial walking must be carried out. In doing so, the following aspects frequently have to be observed, with adjustments as needed:

• Socket flexion position by verifying step length symmetry (sagittal plane)
• Adduction position of the socket and M-L positioning of the socket adapter (frontal plane)
• Rotation position of the knee joint axis and outward rotation of the prosthetic foot (transversal plane)

Use

INFORMATION
Knee joint movement noise
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 unavoidable. It generally does not indicate any problems. If movement noise increases noticeably during the lifecycle of the knee joint, the knee joint should be inspected by an authorised Ottobock Service Centre immediately.

Standing
Knee control through high hydraulic resistance and correct static alignment.
A stance function can be activated using the adjustment app. Please see the following sec­tion for further information on the stance function.

Stance function
The stance function (standing mode) is a functional supplement to the basic mode (mode 1). This function makes it easier, for example, to stand on an inclined surface for a longer time. Depending on the situation, the joint is auto­matically fixed in the flexion direction.

Walking

Initial attempts at walking with the prosthesis always require the instruction of trained, quali­fied personnel.
The hydraulics stabilise the knee joint in the stance phase and release the knee joint in the swing phase so that the prosthesis can swing forward freely.
Switching to the swing phase requires a rollover to the front over the prosthesis out of the stride position. “Start-to-walk” function
With this function, the knee joint can be flexed more easily when starting to take a step without initiating a swing phase. This also makes walking in confined spaces easier since initial flexion is possible not only from the step position via stance release/swing phase initi­ation but also from the standing position.

Optimised slope ascent
This function makes it easier to walk up ramps by automatically increasing the Preflex value depending on the angle of the ramp, making an easier rollover possible by shortening the stride and leg length. Adapted stance phase control occurs during forward movement to enable a physiological movement pattern.

PreFlex
This function ensures that the knee is at 4° of flexion at the end of the swing phase and in preparation for the heel strike. This makes initiating stance phase flexion easier, improves shock absorption and facilitates forward movement.

Running short distances (“walk-to-run” function)
For covering short distances quickly, the knee joint detects a transition from walking to run­ning in basic mode and automatically changes the following settings according to the higher dynamics required while running:

• The swing phase angle is increased
• Preflexion of 4° at heel strike (PreFlex) is reduced to 0°
  The requirements to automatically switch to the running motion are fast forward movement of the prosthetic leg and high dynamic load on the knee joint. When stopping from the running motion, the changed settings are set back to the standard values.

INFORMATION
For running long distances, a “Running” MyMode can be configured via the adjustment app (see page 20).

Sitting down
The resistance in the prosthetic knee joint while sitting down ensures the body is lowered evenly into the sitting position.

1. Place both feet side by side at the same level.
2. While sitting down, weight should be distributed evenly between both legs and the arm supports used if available.
3. Move the buttocks in the direction of the back support and lean the upper body forward.

 Sitting/standing up
If the patient is in a sitting position for more than two seconds, i.e. the thigh is close to horizontal and there is no load on the leg, the knee joint switches the resistance to a minimum in the extension direction.
Getting up is recognised automatically and the resistance is switched back to the normal stance phase resistance.

 Walking up stairs step-over-step/crossing obstacles “Stairs and obstacles” function
Although the knee joint is passive, which means it cannot execute any active movements on its own, climbing stairs step-over-step or crossing obstacles is possible.
This function must be consciously practised and executed.

1. Lift the extended prosthesis off the floor.
2.  Immediately after lifting the extended leg off the floor, extend the hip briefly and then abruptly flex it. This requires adequate suspension in the prosthetic socket and sufficient residual limb strength.
   → This “whip motion” flexes the knee, because the knee joint automatically recognises the movement and reduces the flexion resistance to minimum.
   INFORMATION: To avoid injuries caused by the prosthesis swinging back and up, take note of people behind you before executing the “whip motion”.

Climbing stairs

1. When sufficient knee flexion has been achieved, the knee joint increases extension resistance so that there is enough time to position the foot on the next step before the knee joint is extended again.
2. Set the foot onto the next step or across the obstacle.
   At this time, the knee joint is blocked in the flexion direction and therefore provides support for climbing stairs.
   The foot has to have a sufficient support area on the step so the heel does not project too far over the edge of the step. If the support area is insufficient, the lower leg would extend too early and the function would be deactivated (deactivation of the flexion block, switching to the normal stance phase flexion resistance). In this  phase, the knee joint has already set the flexion resistance to maximum (blocked). The knee joint cannot be flexed further, but only extended. This ensures that the leg does not buckle if the hip strength is not sufficient for the extending motion.
3. The user should use their hand for support on the contralateral side. A flat wall is also sufficient for this purpose.
   This lateral support is intended to prevent twisting of the residual limb in the prosthetic socket, which can cause unpleasant surface tension between the skin and socket. Support also makes it easier to maintain balance.
4. Extend the knee. When the knee joint is fully extended, the initial position has been reached.
5. You can climb the next step or continue walking normally.

Crossing obstacles

1.  With the knee flexed, step over the obstacle. If there is sufficient knee flexion, the extension resistance is increased to allow enough time for crossing the obstacle.

Walking down stairs
This function must be consciously practised and executed. Only when the sole is properly positioned can the knee joint react correctly and permit controlled flexion.

1.  Hold the handrail with one hand.
2. Position the leg with the prosthesis on the step so that the foot projects halfway over the edge of the step.
3.  Roll the foot over the edge of the step.
4. Place the foot of the other leg onto the next step.
5.  Place the leg with the prosthesis on the next step after that.

Walking down a ramp
Under increased flexion resistance, permit controlled flexion of the knee joint which lowers the body’s centre of gravity.

Cycling
When the “Intuitive cycling” function is activated, cycling is detected due to the characteristic cyclical motion of the prosthesis and the resistance in the prosthetic knee joint is reduced. Upon dismounting from the bicycle, the joint switches back to the resistances for walking and standing.

INFORMATION
The user must wear a bicycle helmet to ensure their safety while cycling.
In addition, the bicycle must have a freewheel function, and the shoes may not be secured on the pedals (with clips, click mountings or the like).

 Walking backwards
It is possible to walk backwards safely and quickly without initiating a swing phase and without excessive flexion.
An increased flexion resistance and situation-specific locking angle make it possible to pull a load backwards, for example.

Switching the product on/off

In certain cases, e.g. for storage or transportation, the product can be switched off.
It can be switched on only by connecting to the charging adapter and a USB power source.

Switching off

1. Connect the charging adapter to the prosthetic knee joint with a USB power source.
2. Hold the prosthetic knee joint vertical with the charging adapter connected.
3.  Tilt the prosthetic knee joint forwards by 90° and back to the vertical position twice within 10 seconds.
4. Then disconnect the charging adapter within 5 seconds.
   → A falling tone sequence (dee doo day dah) and a vibration signal are generated. The prosthetic knee joint is then switched off.

INFORMATION
Actual deactivation only some time after playing the melody
When there is a Bluetooth connection to a mobile device (LED on the back of the joint shows continuous blue light ), deactivation occurs only some time after the deactivation melody plays.

Switching on

1. Connect the USB power source to the charging adapter.
2. Connect the charging adapter to the knee joint. → You can tell whether the USB power source is properly connected to the knee joint via the charging adapter based on feedback (see page 30 and see page 32).

Bluetooth

Establishing the Bluetooth connection
The Bluetooth function provides a wireless connection between the component and various devices. Bluetooth must be switched on at the component in order to establish a connection.

• Rotate the prosthesis by 180° (sole of the foot bottom – sole of the foot top) or connect and then disconnect the charging adapter, in order to make the Bluetooth connection recognizable (visible) for 2 minutes.
  → The LED on the back of the prosthetic knee joint flashes blue during this time
  → As long as this LED flashes blue, a Bluetooth connection to a terminal device is possible.

These MyModes are intended for specific types of movement or posture (e.g. golf, basketball, etc.). They can be activated and configured with the adjustment app in addition to basic mode (mode 1). The patient can switch the MyModes using the Cockpit app or movement patterns. Switching by using movement patterns has to be activated in the adjustment app.
Settings can also be adjusted using the Cockpit app.

Running function as configured MyMode

For running over longer periods of time, a “Running” MyMode can be configured using the adjustment app. This mode can be activated using the Cockpit app or a movement pattern. In this mode, every step will be performed as a running step with a larger swing phase angle and no pre-flexion at heel strike (Preflex).

INFORMATION
The running function will work with specialised running feet such as the 1E95 Challenger as well as with prosthet­ic 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.

Switching MyModes using motion patterns

Information on switching

• Before the first step, always check whether the selected mode corresponds to the required motion type.
  Requirements for successful switching using motion patterns
• The following points must be observed to carry out switching successfully:
• Switching using movement patterns has to be enabled in the adjustment app.
• Position the prosthetic leg back slightly and bounce on the forefoot with the leg extended while maintaining constant contact with the floor.
• Weight must be placed on the forefoot while bouncing.
• Do not take the weight off fully during unloading while bouncing.

Switching process

INFORMATION
If the Volume parameter is set to “0” in the Cockpit app, there are no acoustic signals. Observe the vibration signal in this case.

1. While maintaining constant contact with the floor, bounce on the forefoot with the leg extended according to the desired MyMode (MyMode 1 = three times, MyMode 2 = four times).
2. Keep the prosthetic leg still in this position (step position) without placing weight on it.
   → A vibration signal and acoustic signal will be emitted to confirm that the movement pattern has been recognised (see page 29).
   INFORMATION: If this vibration signal and acoustic signal are not emitted, the requirements were not met while bouncing the forefoot.
3.  After the vibration signal and acoustic signal are emitted, keep the prosthetic leg extended with no load for 1 second.
   → A vibration signal and acoustic signal (two times = MyMode 1, three times = MyMode 2) are emitted to indicate successful switching to the respective MyMode.
   INFORMATION: If this vibration signal and the corresponding acoustic signal are not emitted, the leg with the prosthesis was not held still correctly. Repeat the process to switch MyModes correctly.

 Switching from a MyMode back to basic mode

Information on switching

1. Regardless of the configuration of the MyModes in the adjustment app, it is always possible to switch back to basic mode (mode 1) using a movement pattern.
   • It is always possible to switch back to basic mode (mode 1) by connecting/disconnecting the charging adapter.
   • Note the prerequisites for successfully switching using movement patterns at the start of the previous section.
   • Before the first step, always check whether the selected mode corresponds to the required motion type.

Switching process

INFORMATION
If the Volume parameter is set to “0” in the Cockpit app, there are no acoustic signals. Observe the vibration signal in this case.

1. Position the prosthetic leg slightly to the rear (step position).
2. While maintaining constant contact with the floor, and with the leg extended, bounce on the forefoot three or more times.
3. Keep the prosthetic leg still in this position (step position) without placing weight on it.
   → A single vibration signal and acoustic signal will be emitted to confirm that the movement pattern has been recognised (see page 29).
   INFORMATION: If this vibration signal and acoustic signal are not emitted, the requirements were not met while bouncing the forefoot.
4. After the vibration signal and acoustic signal are emitted, keep the prosthetic leg extended with no load.A single vibration signal and acoustic signal will be emitted to indicate successful switching to basic mode. INFORMATION: If this vibration signal and acoustic signal are not emitted, the leg with the prosthesis was not held still correctly. Repeat the process to switch MyModes correctly.

Additional operating states (modes)

Empty battery mode
Acoustic signals sound if the available battery charge level is less than 1 per cent (see page 29). Following the acoustic signals, the flexion resistance is set to the safety mode values. This flexion resistance may be low or high depending on the setting in the adjustment app. Then the product is switched off.
After the charging process has been completed (disconnection of the charging adapter from the product), basic mode (mode 1) is activated again.

Mode for charging the prosthesis
The product is non-functional during charging.
The flexion resistance is set to the safety mode values. This can be low or high depending on the setting in the adjustment app.

 Safety mode
The product automatically switches to safety mode if a critical error occurs (e.g. failure of a sensor signal) or if the battery is drained. Safety mode remains in effect until the error has been rectified.
A flexion resistance (Safety mode flexion resistance) configured in the adjustment app is activated in safety mode. This resistance can be set to low or high. If the resistance is set to low, note that the heel strike has to be actively secured through hip extension to prevent falling or unintentional flexing/buckling. The extension resistance is low and cannot be changed. Stance release is not possible. This makes limited walking possible for the patient and allows the patient to sit down, even though the sensor system is not active.
The switch to safety mode is indicated directly beforehand by an acoustic and vibration signal (see page 29). Safety mode can be disabled by connecting and then disconnecting the charging adapter from the knee joint. The charging adapter has to stay connected until the status LED on the knee joint lights up yellow before it is discon­nected. If the knee joint switches into safety mode again, this means there is a permanent error. The knee joint must be inspected by an authorised Ottobock Service Center.
If the temperature continues to increase in overheating mode and the critical temperature of the hydraulics is reached (see the section “Reaching the critical temperature of the hydraulics”), the product first switches to safety mode and then turns off. It automatically switches on again after cooling down.

Overheating mode
When the knee joint gets very hot due to uninterrupted, increased activity (e.g. extended walking downhill) or external heat sources (sunlight), the flexion resistance is increased along with the rising temperature in order to counteract the overheating. After the knee joint cools down, it switches back to the settings that existed prior to overheating mode.
In the MyModes, the overheating mode signal is generated but there is no increase in the flexion resistance. Overheating mode is indicated by 4 high sounds (deen deen deen deen) that are repeated every 5 seconds. In addition, the status LED on the back of the knee joint slowly flashes yellow.

The following functions are deactivated in overheating mode:

• Switching to a MyMode
• Changes to the prosthesis setting

Reaching the critical temperature of the hydraulics
If activity continues despite switching to overheating mode, safety mode is activated once the critical temperature of the hydraulics is reached and the knee joint is then turned off. The status LED lights up red to indicate switching to this mode.
The knee joint is automatically switched on again after it cools.

Storage

• Before storing the knee joint, the knee head has to be extended. The knee head must not be flexed!
• Avoid extended disuse of the product (use the product regularly).
• Avoid prolonged storage and/or transportation of the product at high temperatures.

 Cleaning

Cleaning the knee joint

 Cleaning the knee joint with 2R68=280 Axon tube adapter

• In case of soiling, clean the product with clear fresh water and pH-neutral soap (e.g. Ottobock Derma Clean 453H10=1-N) at a water temperature between 10°C (50°F) and 40°C (104°F).
• Rinse the soap away with clear fresh water (e.g. under a shower).
  If dirt cannot be removed, even with a jet of water from a garden hose, the product must be sent to an authorised Ottobock Service Center.
• Dry the product with a lint-free cloth and allow it to air dry fully.
• If necessary, disinfect the surface by wiping with a surface disinfectant (e.g. Descosept Pur) and drying.

INFORMATION
Please note that the weight of dirt adhering to the prosthesis can affect the gait pattern.

Cleaning after contact with salt water

1. Remove all covers installed on the knee joint (Protective Cover short, Protective Cover long, functional cosmesis).
2. Rinse the knee joint and AXON tube adapter with clear fresh water.
   For the cleaning instructions for the other components, see the instructions for use included with these components.
3. Dry the components with a soft cloth.
4. Allow them to fully air dry in order to remove all residual moisture.

In case of a malfunction after drying, the knee joint and AXON tube adapter must be inspected by an authorised Ottobock Service Center.

Cleaning after contact with solutions other than fresh or salt water

1. Promptly remove all covers installed on the knee joint (Protective Cover short, Protective Cover long, functional cosmesis).
2. Promptly rinse the knee joint and AXON tube adapter with clear fresh water. For the cleaning instructions for the other components, see the instructions for use included with these components.
3. Dry the components with a soft cloth.
4.  Allow them to fully air dry in order to remove all residual moisture.
   In case of a malfunction after drying, the knee joint and AXON tube adapter must be inspected by an authorised Ottobock Service Center.

Cleaning the knee joint with 2R69=280 Axon tube adapter with torsion

1. Clean the product with a damp cloth and mild soap (e.g. 453H10=1-N Ottobock Derma Clean) when needed.
2. Ensure that no liquid penetrates into the tube adapter.
   Dry the product with a lint-free cloth and allow it to air dry fully.
3. If necessary, disinfect the surface by wiping with a surface disinfectant (e.g. Descosept Pur) and drying.

Cleaning the charging adapter

1. Clean the product with a damp cloth and mild soap (e.g. 453H10=1-N Ottobock Derma Clean) when needed.
   Make sure that no liquid penetrates into the product.
2. Dry the product with a lint-free cloth and allow it to air dry fully.
3. If necessary, disinfect the surface by wiping with a surface disinfectant (e.g. Descosept Pur) and drying.

Clean the electrical contacts of the charging plug and charging receptacle regularly using a cotton swab and mild soap solution.
NOTICE! Take care to avoid damaging the coating of the contact surfaces with pointed or sharp objects.

Maintenance

• Regular maintenance (service inspections) at 24-month intervals or every 2.8 million steps, whichever comes first, is mandatory in the interest of patient safety and in order to maintain operating reliability and protect the warranty, maintain basic safety and the essential performance characteristics, and ensure safety with regard to EMC.
• The maintenance interval may be reduced by unusual strain.
• When maintenance is due, this is indicated by feedback (see the section “Operating states/error signals”, see page 29).
• The following components must always be sent in for maintenance and repairs:
• The product with installed tube adapter, with installed flexion stops, charging adapter, USB cable and power supply unit used. The packaging material for the loaner unit you previously received must be reused for sending back the components requiring inspection.
• Before shipping, the knee head of the prosthetic knee joint has to be extended. The knee head must not be flexed!

Legal information

All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.

 Liability
The manufacturer will only assume liability if the product is used in accordance with the descriptions and instructions provided in this document. The manufacturer will not assume liability for damage caused by disregarding the information in this document, particularly due to improper use or unauthorized modification of the product.

Trademarks
All product names mentioned in this document are subject without restriction to the respective applicable trademark laws and are the property of the respective owners.
All brands, trade names or company names may be registered trademarks and are the property of the respective owners.
Should trademarks used in this document fail to be explicitly identified as such, this does not justify the conclusion that the denotation in question is free of third-party rights.
Bluetooth is a registered trademark of Bluetooth SIG, Inc.

CE conformity
The following products meet the requirements of the listed European standards. The CE declarations of conformity can be downloaded from the respective manufacturer’s website.

Product	Reference number	Specifications
Genium X4	3B5-4=*	Regulation 2014/53/EU	(EU)	2017/745,	Directive	2011/65/EU,	Directive
		Ottobock Healthcare Products GmbH hereby declares that the radio equipment [3B5-4=* Genium X4] complies with Directive 2014/53/EU. The full text of the EU declaration of conformity is available under the following Internet address: https://www.ottobock.com/conformity
AXON tube adapter	2R68=280, 2R69=280	Regulation (EU) 2017/745, Directive 2011/65/EU

Product	Reference number	Specifications
Power supply unit	757L48=1	Directive      2014/35/EU,       Directive      2014/30/EU,       Directive 2011/65/EU, Directive 2009/125/EG, Regulation (EU) 2019/1782
USB charging adapter	757L47=1	Regulation (EU) 2017/745, Directive 2011/65/EU

Local Legal Information
Legal information that applies exclusively to specific countries is written in the official language of the respective country of use in this chapter.
This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions:

1. This device may not cause harmful interference, and
2. This device must accept any interference received, including interference that may cause undesired operation. This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules.

These limits are designed to provide reasonable protection against harmful  interference in a residential installation. This equipment generates uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harm­ful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is connected.
• Consult the dealer or an experienced radio/ TV technician for help.
• Any changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
• Caution: Exposure to Radio Frequency Radiation.
• This device must not be co-located or operating in conjunction with any other antenna or transmitter.
• Caution: Federal law (USA) restricts this device to sale by or on the order of a practitioner licensed by law of the State in which he/she practices to use or order the use of the device.

Technical data

Environmental conditions

Transport in original packaging

Transport and storage between applications (without packaging)

Storage in the original packaging (≤3 months)

Storage and transport in original packaging (>3 months)

Operation

Maximum temperature that can be reached at the con­ nection piece between the knee joint and the prosthetic socket before switching to overheating mode

Time for warming to the operating temperature after storage between applications, from -20 °C/-4 °F at an ambient temperature of +20 °C/+68 °F

Environmental conditions
Time for cooling to the operating temperature after stor­ age between applications, from +60 °C/+140 °F at an ambient temperature of +20 °C/+68 °F	30 minutes
Charging the battery	+5 °C/+41 °F to +40 °C/+104 °F 15% to 90% relative humidity, non-condensing Air pressure: 70 kPa to 106 kPa (- 425 m to 3000 m without pressure equalisation)

Knee joint
Reference number	3B5-4=P / 3B5-4=ST
Mobility grade according to MOBIS	2, 3 and 4
Maximum body weight	150 kg
Permissible additional weight at max. body weight	15 kg
Protection rating	IP66/IP68 Maximum water depth: 3 m Maximum time: 1 hour
Waterproofness	Waterproof, corrosion-resistant, protected against the penetration of jets of water
Proximal system height up to alignment reference point 3B5-4=P (with pyramid) / 3B5-4=ST (with threaded con­ nector)	0 mm / 26 mm
Minimum knee pivot point to ground measurement when using 2R68=280/2R69=280 and 1C63	359 mm
Minimum          distal         system         height         with 2R68=280/2R69=280 tube adapter	299 mm / 330 mm
Maximum         distal         system        height         with 2R68=280/2R69=280 tube adapter	514 mm / 545 mm
Maximum possible flexion angle	135°
Maximum possible flexion angle with preinstalled 22.5° flexion stop	112.5°
Maximum possible flexion angle with 15° flexion stop	120°
Maximum possible flexion angle with 7.5° flexion stop	127.5°
Maximum insertion depth of the tube adapter in the knee joint	70 mm
Weight of the prosthesis without tube adapter	Approx. 1600 g
Information on the version of the software package	Accessible using the adjustment app
Expected lifetime given compliance with prescribed maintenance intervals	6 years
Test procedure	ISO 10328-P7-150 kg/3 million load cycles

Data communication
Wireless technology	Bluetooth 5.0 (Bluetooth Low Energy)
Distance range	Approx. 10 m / 32.8 ft
Frequency range	2,402 MHz to 2,480 MHz
Modulation	GFSK
Data rate (over the air)	Up to 2 Mbps
Maximum output power (EIRP):	+4 dBm (~2.5 mW)

Axon tube adapter
Reference number	2R68=280
Weight	190 g -300 g
Material	Aluminium
Max. body weight	150 kg

Axon tube adapter
Protection rating	IP66 / IP68 Maximum water depth: 3 m Maximum time: 1 hour
Water resistance	Waterproof and corrosion-resistant
Expected lifetime	6 years
Approved set screws
Length	16 mm
Reference number	506G3=M8x16 ZN
Maximum tightening torque	15 Nm

Axon tube adapter with torsion
Reference number	2R69=280
Weight	190 g–300 g
Material	Aluminium
Max. body weight	125 kg
Protection rating	IP54
Waterproofness	Not waterproof and not corrosion-resistant
Expected lifetime	6 years
Approved set screws
Length	10 mm	12 mm	14 mm	16 mm
Reference number	506G3=M8x­ 10	506G3=M8x­ 12	506G3=M8x­ 14	506G3=M8x­ 16
Maximum tightening torque	15 Nm

Prosthesis battery
Battery type	Li-ion
Charging cycles (charging and discharging cycles) after which at least 80% of the original battery capacity remains available	500
Behaviour of the product during the charging process	The product is non-functional.
Operating time of the prosthesis with new, fully charged battery at room temperature	Approx. 5 days with average use

The following charging times apply only when the provided power supply unit and the provided USB cable are used:

Charging time of the prosthesis battery
Charge level after 1 hour charging time	35 %
Charge level after 2 hours charging time	70 %
Charge level after 3 hours charging time	90 %
Charge level after 4 hours charging time	Fully charged

Charge level	Walking	Sitting
20 %	3.5 – 6.5 hours	32 – 54 hours
15 %	2.5 – 4.5 hours	35 – 39.5 hours
10 %	1.5 – 3 hours	15 – 25.5 hours
5 %	0.5 – 1 hour	6.5 – 11 hours

Power supply unit
Reference number	757L48=1
Type	BI18-050300-IU

Power supply unit
Mains plug	NEMA-1 (type A) e.g.: North America Euro plug (type C) e.g.: Europe The following country adapters are available as accessories: G-Type, BS1363 for UK and I-Type for Australia
Storage and transport with/without packaging	-20 °C/-4 °F to +60 °C/+140 °F 5 % to 95 % relative humidity, non-condensing
Operation	0 °C/+32 °F to +40 °C/+104 °F max. 90 % relative humidity Air pressure: 70 kPa to 106 kPa (-425 m to 3000 m without pressure equalisation)
Input voltage	100 V~ to 240 V~
Mains frequency	50 Hz to 60 Hz
Output voltage	5 V
Output current	3 A
Lifetime	8 years

Charging adapter
Reference number	757L47=1
Storage in original packaging	5 °C/+41 °F to +40 °C/+104 °F 15% to 90% relative humidity
Transport in original packaging	-25 °C/-13 °F to +70 °C/+158 °F 15% to 90% relative humidity, non-condensing
Transport and storage between applications (without packaging)	-25 °C/-13 °F to +70 °C/+158 °F 15% to 90% relative humidity, non-condensing Air pressure: 70 kPa to 106 kPa (-425 m to 3000 m without pressure equalisation)
Operation	5 °C/+41 °F to +40 °C/+104 °F 15% to 90% relative humidity Air pressure: 70 kPa to 106 kPa (-425 m to 3000 m without pressure equalisation)
Input jack	USB-C
Input voltage	5 V
Minimum input current	2.5 A
Output voltage	12 V
Output current	0.96 A
Weight	90 g
Lifetime	8 years

Torque values of the screw connections
Using a torque wrench, tighten the corresponding screws alternately in several cycles until the specified tightening torque is reached.

Screw connection	Tightening torque
Tube adapter on prosthetic foot	15 Nm / 133 lbf. In.
Tube clamp of the knee joint	7 Nm / 62 lbf. In.
Proximal prosthesis components with pyramid receiver	15 Nm / 133 lbf. In.
Proximal prosthesis components with threaded connect­ or	10 Nm / 89 lbf. In.
Flexion stop	0.6 Nm / 5 lbf. In.

Appendices

 Symbols Used

Operating states/error signals
The prosthesis indicates operating states and error messages with vibration and acoustic signals, and by the illu­mination of the status LED and the Bluetooth LED above the charging receptacle.

Illustration of the LED symbols

Brief description of the acoustic signals
The description of the signal only serves as a rough overview. More detailed information is found in the sections that follow.

Acoustic signals	Text description	Time of occurrence/meaning
(dee doo day dee doo day)	Double tone sequence with a high tone followed by a medium and a low tone	Maintenance date exceeded, critical temperature of the hydraulics reached, error (active safety mode, tube adapter not connected)

 Signals for operating states Charging adapter connected/disconnected

Switching modes/changing settings
The volume of the listed signals can be changed in the Cockpit app.

Bluetooth connection

LED	Event
	The Bluetooth function is activated. The knee joint is in connection mode for 2 minutes. During this time, the knee joint can be recognised by a mobile device and the connection can be established.
	Bluetooth connection established between the mobile device and the knee joint.

 Warnings/error signals Error during use

 Status signals
Battery charge level
Feedback after rotating the prosthesis by 180° (sole of the foot down – sole of the foot up).

 LED symbols on the charging adapter

Status LED and battery symbol

Temperature LED

Maintenance LED

Directives and manufacturer’s declaration

 Electromagnetic environment
This product is designed for operation in the following electromagnetic environments:

• Operation in a professional healthcare facility (e.g. hospital, etc.)
• Operation in areas of home healthcare (e.g. use at home, use outdoors)
  The customer or user of the product must ensure that it is operated in such an environment. Observe the safety notices in the section “Safety” (see page 9).

Electromagnetic emissions

Interference measure­ ments	Compliance	Electromagnetic environment directive
HF emissions according to CISPR 11	Group 1/class B	The product uses HF energy exclusively for its internal functioning. Its HF emissions are therefore very low, and interference with neighbouring electronic devices is unlikely.
Harmonics    according    to IEC 61000-3-2	Not applicable – power below 75 W	–
Voltage fluctuations/flicker according    to IEC 61000-3-3	Product meets the require­ ments of the standard.	–

Electromagnetic interference immunity

Phenomenon	EMC basic standard or Test procedure	Interference immunity test level
Electrostatic discharge	IEC 61000-4-2	± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air (except included power supply unit)
High-frequency   electro­ magnetic fields	IEC 61000-4-3	10 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz
Magnetic fields with rated power frequencies	IEC 61000-4-8	30 A/m 50 Hz or 60 Hz
Electrical   fast  transi­ ents/bursts	IEC 61000-4-4	± 2 kV 100 kHz repetition rate
Surges Line against line	IEC 61000-4-5	± 0.5 kV, ± 1 kV

Phenomenon	EMC basic standard or Test procedure	Interference immunity test level
Conducted interference induced by high-frequency fields	IEC 61000-4-6	3 V 0.15 MHz to 80 MHz 6 V in ISM and amateur frequency bands between 0.15 MHz and 80 MHz 80% AM at 1 kHz
Voltage drops	IEC 61000-4-11	0% UT; 1/2 period At 0, 45, 90, 135, 180, 225, 270 and 315 degrees
		0% UT; 1 period and 70% UT; 25/30 periods Single phase: at 0 degrees
Voltage interruptions	IEC 61000-4-11	0% UT; 250/300 periods

Interference resistance against wireless communication devices

Test fre­ quency [MHz]	Frequency band [MHz]	Radio service	Modulation	Maximum power [W]	Distance [m]	Interference immunity test level [V/m]
385	380 to 390	TETRA 400	Pulse modula­ tion 18 Hz	1.8	0.3	27
450	430 to 470	GMRS 460, FRS 460	FM ± 5 kHz    devi­ ation 1 kHz sine	1.8	0.3	28
710	704 to 787	LTE band 13, 17	Pulse modula­ tion 217 Hz	0.2	0.3	9
745
780
810	800 to 960	GSM 800/900, TETRA 800, iDEN 820, CDMA 850, GSM 800/900, LTE band 5	Pulse modula­ tion 18 Hz	2	0.3	28
870
930
1,720	1,700 to 1,990	GSM 1800; CDMA 1900; GSM 1900; DECT; LTE band 1, 3, 4, 25; UMTS	Pulse modula­ tion 217 Hz	2	0.3	28
1,845
1,970
2,450	2,400 to 2,570	Bluetooth WLAN 802.11­ b/g/n, RFID 2450 LTE band 7	Pulse modula­ tion 217 Hz	2	0.3	28
5,240	5,100 to 5,800	WLAN 802.11­ a/n	Pulse modula­ tion 217 Hz	0.2	0.3	9
5,500
5,785

Immunity to magnetic fields in close range

Test frequency	Modulation	Interference immunity test level [A/m]
30 kHz	CW	8
134.2 kHz	Pulse modulation 2.1 kHz	65
13.56 MHz	Pulse modulation 50 kHz	7.5

Otto Bock Healthcare Products GmbH
Brehmstraße 16 · 1110 Wien · Austria
T +43-1 523 37 86
F +43-1 523 22 64
info.austria@ottobock.com
www.ottobock.com

Documents / Resources

ottobock Genium X4 Microprocessor [pdf] Instruction Manual 3B5-4 P, 3B5-4 ST, Genium X4 Microprocessor, Genium X4, Microprocessor

References

• User Manual