Otto Bock AxonArm Ergo 12K501 User manual

Instructions for use (qualified personnel) ................................................................. 3
AxonArm Ergo 12K501=*

1
2
2 AxonArm Ergo 12K501=*

Foreword1 5..............................................................................................................................................................
Product description2 5............................................................................................................................................
Construction and Function2.1 5.....................................................................................................................
Definition of terms2.2 5.................................................................................................................................
Intended use3 6........................................................................................................................................................
Indications for use3.1 6................................................................................................................................
Conditions of use3.2 6..................................................................................................................................
Contraindications3.3 6.................................................................................................................................
Qualification3.4 6.........................................................................................................................................
Safety4 6....................................................................................................................................................................
Explanation of warning symbols4.1 6..............................................................................................................
Structure of the safety instructions4.2 6..........................................................................................................
General safety instructions4.3 7.....................................................................................................................
Scope of Delivery and Accessories5 8..................................................................................................................
Scope of delivery5.1 8..................................................................................................................................
Accessories5.2 9.........................................................................................................................................
Preparing the product for use6 9...........................................................................................................................
Installing the AxonRotation Adapter6.1 9.........................................................................................................
AxonMaster6.2 10........................................................................................................................................
Controlling the Electronic Lock6.2.1 10.............................................................................................................
Connecting the Electrodes6.2.2 10...................................................................................................................
Installing the AxonMaster in the Upper Arm Socket6.2.3 10.................................................................................
Sealing the prosthesis6.2.4 10.........................................................................................................................
Connecting the AxonMaster to the EasyPlug6.2.5 11..........................................................................................
Installing the EasyPlug6.3 11.........................................................................................................................
Connecting the Elbow Joint to the Upper Arm6.4 11.........................................................................................
Setting the Preflexion6.5 12...........................................................................................................................
Adjusting the Humeral Rotation Feature6.6 14.................................................................................................
Installing the Pull Cable6.7 14.......................................................................................................................
Checking the Symmetry6.8 14.......................................................................................................................
Handling7 15.............................................................................................................................................................
Charging the Battery7.1 15...........................................................................................................................
Charging Receptacle7.2 15...........................................................................................................................
Determining the Battery Charge Level7.3 15...................................................................................................
Switching On the Axon-Bus Prosthetic System7.4 15.......................................................................................
Switching Off the Axon-Bus Prosthetic System 7.5 15......................................................................................
Safety Shutoff7.6 15.....................................................................................................................................
Open the Axon-Bus Gripping Component in an Emergency7.7 16.....................................................................
Bluetooth Function7.8 16..............................................................................................................................
Beep Function7.9 16....................................................................................................................................
Data transfer between the product and the PC7.10 16.......................................................................................
Legal information8 17..............................................................................................................................................
Liability8.1 17..............................................................................................................................................
Trademarks8.2 17........................................................................................................................................
CE conformity8.3 17.....................................................................................................................................
Local Legal Information8.4 17.......................................................................................................................
Technical data9 18...................................................................................................................................................
Appendices10 18........................................................................................................................................................
Symbols Used10.1 18....................................................................................................................................
Fault Display and Fault Elimination10.2 19........................................................................................................
LED flashes red and beeper sounds for 3 seconds10.2.1 19..................................................................................
The LED flashes three times after pressing the button in the colour of the current battery capacity10.2.2 19................
LED alternately flashes yellow/red and beeper sounds for 3 seconds 10.2.3 19........................................................
Table of contents
3AxonArm Ergo 12K501=*
Table of contents

The movements of the Axon-Bus gripping component are becoming increasingly slower10.2.4 19..............................
Axon10.3 19..................................................................................................................................................
4 AxonArm Ergo 12K501=*
Table of contents

1 Foreword
INFORMATION
Date of last update: 2022-07-07
►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 each serious incident related to the product to the manufacturer and to the relevant authority in your
country. This is particularly important when there is a decline in the health state.
►Please keep this document for your records.
The 12K501 AxonArm Ergo is referred to simply as the AxonArm or the product 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 sup
plied.
2 Product description
2.1 Construction and Function
The 12K501 AxonArm Ergo is a myoelectrically locked elbow joint. Locking and unlocking is controlled myoelectric
ally by means of electrode signals or with a switch.
The AxonArm Ergo helps the patient perform everyday tasks in combination with other prosthetic components of
the Axon-Bus prosthesis solution, such as the 8E500 Michelangelo hand.
A lithium-ion battery integrated into the product provides the required energy.
If the elbow joint is switched off or the battery is depleted, the pull cable can be used to lock and unlock the elbow
joint in any position, even when loaded.
2.2 Definition of terms
AFB (Automatic Forearm Balance)
AFB is a flexion assist in the form of a mechanical gear mechanism in the forearm of the elbow joint. The Automatic
Forearm Balance provides for harmonious movement control, free swing and reduction of energy consumption. It
stores the energy that is released when the arm is extended and uses this to assist with flexion. The degree of flex
ion assistance can be adjusted to the individual weight of the prosthetic forearm and to different clothing by means
of a dial.
The free swing of the forearm corresponds to the natural movement behaviour of the upper limb while walking.
After extension of the forearm, the vario-gear automatically decouples the forearm from the drive unit so it can
swing freely. The AFB slightly dampens the free swing, thereby making a close approximation of the forearm’s
physiological movement behaviour possible.
The product does not consume electrical energy during the free swing. A short muscle signal to flex the product
ends the free swing.
Easy Plug
The Easy Plug is a through-connection for myoelectrically controlled prostheses that is integrated in the elbow
joint.
The connecting cables of the electrodes, switches and batteries are connected to the Easy Plug. Its interior cable
routing minimises the risk of cable breaks.
With the AxonArm, only the 13E500 AxonMaster is connected in the area of the elbow ball. All other plug connec
tions have no function and are therefore closed with cover caps.
Forearm cable
The forearm cable establishes the electrical connection between the product and the terminal device. The cable is
rolled up in the forearm of the elbow joint on delivery and can be replaced in case of damage.
Lock
Releasing and locking the elbow joint is automated according to operating situations, the applied load and the con
trol signal generated by the patient by means of the electronically controlled locking drive.
5AxonArm Ergo 12K501=*
Foreword

The product has a load capacity of up to 230N in the locked state with a forearm lever length of 305mm. The lock
will slip under higher loads.
Mechanical release
With the product switched off or when the battery is drained, the elbow can be manually unlocked and locked
again with a slight pull on the unlock cable. In this way, the forearm can be brought into the desired position.
Mechanical release can also take place under load.
Electronic release
Locking and unlocking is controlled by myoelectric electrode signals or a switch. These control devices have to be
connected to the 13E500 AxonMaster. See the corresponding instructions for use for further information on control
devices and control programs.
Control of the electronic lock
Myoelectric control of the electronic lock can be realised in the following ways:
• One long co-contraction on channel 1 and 2 of the AxonMaster releases or engages the lock.
• A short co-contraction switches the grip of the terminal device.
• An impulse on channel 3 of the AxonMaster releases or engages the lock.
3 Intended use
3.1 Indications for use
The product is intended exclusively for upper limb exoprosthetic fittings.
3.2 Conditions of use
The product is designed for use by unilateral or bilateral amputees.
The product is intended exclusively for use on adults.
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.).
3.3 Contraindications
• All conditions which contradict or go beyond the specifications listed in the section on "Safety" and "Indica
tions for use".
3.4 Qualification
The fitting of a patient with the product may only be carried out by O&P professionals who have been authorised
with the corresponding Ottobock training.
4 Safety
4.1 Explanation of warning symbols
CAUTION Warning regarding possible risks of accident or injury.
NOTICE Warning regarding possible technical damage.
4.2 Structure of the safety instructions
CAUTION
The heading describes the source and/or the type of hazard
The introduction describes the consequences in case of failure to observe the safety instructions. Consequences
are presented as follows if more than one consequence is possible:
> E.g.: Consequence 1 in case of failure to observe the hazard
> E.g.: Consequence 2 in case of failure to observe the hazard
►This symbol identifies activities/actions that must be observed/carried out in order to avert the hazard.
6
Intended use
AxonArm Ergo 12K501=*

4.3 General safety instructions
CAUTION
Non-observance of safety instructions
Personal injury/damage to the product due to using the product in certain situations.
►Observe the safety instructions and the stated precautions in this accompanying document.
CAUTION
Signs of wear and tear on the product components
Injury due to faulty control or malfunction of the product
►In the interest of preventing patient injuries and to maintain product quality, we recommend performing regu
lar service.
►Please see the service pass for more information about the service intervals. This is included in the purchased
extended warranty packages.
CAUTION
Insufficient distance to HF communication devices (e.g. mobile phones, Bluetooth devices, WiFi
devices)
Injury due to unexpected behaviour of the product caused by interference with internal data communication.
►Therefore, keeping a minimum distance of 30cm from HF communication devices is recommended.
CAUTION
Proximity to sources of strong magnetic or electrical interference (e.g. theft prevention systems, metal
detectors)
Injury due to unexpected behaviour of the product caused by interference with internal data communication.
►Avoid remaining in the vicinity of visible or concealed theft prevention systems at the entrance/exit of stores,
metal detectors/body scanners for persons (e.g. in airports) or other sources of strong magnetic and electric
al interference (e.g. high-voltage lines, transmitters, transformer stations, computer tomographs, magnetic
resonance tomographs, etc.).
►When walking through theft prevention systems, body scanners or metal detectors, watch for unexpected
behaviour of the product.
CAUTION
Operating the product in very close proximity to other electronic devices
Injury due to unexpected behaviour of the product caused by interference with internal data communication.
►Do not operate the product in the immediate vicinity of other electronic devices.
►Do not stack the product with other electronic devices during operation.
►If simultaneous operation cannot be avoided, monitor the product and verify proper use in the existing setup.
CAUTION
Operator errors during the adjustment procedure
Injury due to faulty control of the Axon-Bus prosthesis system.
►Participation in an Ottobock product training course is mandatory prior to using the product. During product
training, you will receive a password which provides you with authorisation to access the 560X500=* AxonSoft
software. To qualify for software updates, additional product training courses may be necessary.
►Do not share your unlock PIN.
►Use the online help which is integrated into the software.
7AxonArm Ergo 12K501=*
Safety

CAUTION
Independent manipulation of Axon-Bus components
Injury due to faulty control or malfunction of the Axon-Bus prosthetic system.
►Manipulations to the Axon-Bus prosthetic system other than the tasks described in these instructions for use
are not permitted.
►Do not damage the battery or separate the connection cables between the battery packs.
►The Axon-Bus prosthetic system and any damaged Axon-Bus components may only be opened and/or
repaired by certified Ottobock Myo-Service technicians.
CAUTION
Incorrect electrode settings
Injury due to faulty control or malfunction of the product.
►The electrodes are to be placed on intact skin only and with as much electrode-skin contact as possible. In
the case of strong interference from electronic devices, the position of the electrodes should be checked and
changed if necessary. If the interference cannot be eliminated or if you do not achieve the expected results by
adjustment or selection of the appropriate control programme, please contact Ottobock Myo-Service.
►Set the electrode gains as low as possible to reduce the risk of malfunctioning due to strong electromagnetic
radiation (e.g. visible or concealed theft prevention systems at the entrance/exit of stores, metal detect
ors/body scanners for persons (e.g. in airports) or other sources of strong electromagnetic interference (e.g.
high-voltage lines, transmitters, transformer stations, computer tomographs, magnetic resonance tomo
graphs, etc.).
►Allow the patient to rest during the adjustment of the electrodes; otherwise, muscle fatigue will lead to incon
sistent results. As a result, the therapist will tend to set the electrode gains too high.
CAUTION
Risk of pinching in elbow joint flexion region
►Injuries due to pinching of body parts.
→Ensure that fingers and other body parts are not in this area when bending the elbow joint.
CAUTION
Manual unlocking of elbow lock under load
Injury by release of elbow lock under load.
►Particular caution should be exercised when unlocking the elbow lock while lifting heavy loads.
►Be careful when unlocking the lock under such conditions due to the possibility of injury.
CAUTION
Penetration of dirt and moisture
Injury due to faulty control or malfunction of the Axon-Bus prosthetic system.
►Do not let foreign particles or liquids get into the prosthetic arm.
►Do not expose the prosthetic arm, especially the elbow joint, to dripping or splashing water.
►Wear the prosthetic arm and especially the elbow joint under suitably resistant clothing in the rain.
NOTICE
Coating, gluing or painting the product
Damage or fracture due to chemical processes.
►The product must not be coated, glued or painted.
5 Scope of Delivery and Accessories
5.1 Scope of delivery
• 1pc. 12K501 AxonArm Ergo
• 1pc. Lamination protection cover (disc with arrow)
• 1pc. Lamination protection cover (hollow ball)
• 1pc. Cable lock
8
Scope of Delivery and Accessories
AxonArm Ergo 12K501=*

• 2 pc. bracket cover
• 1pc. lamination ring
• 1 pc. 13Z146 lamination ring (for Axon-Bus terminal device)
• 1pc. clamp ring
• 4 pcs. mounting brackets
• 1pc. spherical cord lock
• 4 pc. Cable ties
• 4pcs. oval head self-tapping screw
• 1pc. Instructions for use (qualified personnel)
• 1pc. Technical information (qualified personnel)
5.2 Accessories
• 757L500 AxonCharge Integral
• 13E500 AxonMaster
• 9S501 AxonRotation Adapter (passive rotation unit)
• 13E200=* or 13E202=* electrode
• "560X500=* AxonSoft" adjustment software
• Axon-Bus terminal device (e.g. 8E500 Michelangelo hand)
• 9X18 Cable pull switch
• Prosthetic glove (e.g. 8S500=R/L AxonSkin Natural when 8E500 Michelangelo hand is used)
Additional MyoBock components such as suction socket electrode, electrode cable, pull-in tube and tube valve for
suction socket as needed.
6 Preparing the product for use
6.1 Installing the AxonRotation Adapter
1) Use silicone grease to seal the plug connection.
2) Connect the AxonRotation Adapter with the con
necting cable.
3) Position the AxonRotation Adapter such that the
middle screw holes on the lamination ring can
be used.
INFORMATION: The other screw positions can
be used for correcting the alignment of the
AxonRotation Adapter after the lamination ring
has been glued in.
4) Screw the AxonRotation Adapter to the lamination
ring.
9AxonArm Ergo 12K501=*
Preparing the product for use

6.2 AxonMaster
Various control programmes and switching methods as well as the option of making refined patient-specific set
tings are available for optimum adaptation to the patient. The standard programmes can be selected using the
560X500=* AxonSoft adjustment software and include predefined control options and switching methods.
Two MyoBock electrodes, e.g., 13E200/202=*, or if necessary a pull switch, e.g., 9X18, can be connected to the
13E500 AxonMaster. For information please refer to the 647G590 instructions for use for the 13E500 AxonMaster
Input on AxonMaster Electrode
Input 1 Closing the hand
Input 2 Opening the hand
Input 3 Pull switch (optional)
►Remove the cover caps from the required inputs. The remaining inputs cannot be used at this time and there
fore remain covered by the caps.
6.2.1 Controlling the Electronic Lock
The electronic lock can be controlled myoelectrically by the following means configured at the factory:
• A long co-contraction on channels 1 and 2 of the AxonMaster releases or locks the lock.
• A short co-contraction switches the gripping mode of the gripper.
• A pulse on channel 3 of the AxonMaster releases or locks the lock.
6.2.2 Connecting the Electrodes
1) Remove the cover caps from the required inputs.
2) Seal the slots on the AxonMaster with silicone
grease.
3) Connect the electrode cables to the AxonMaster.
Observe the slot assignments:
Slot 1: close
Slot 2: open
Slot 3: pull switch (optional)
6.2.3 Installing the AxonMaster in the Upper Arm Socket
The AxonMaster can be secured with adhesive tape or a hook-and-loop fastening strap. The AxonMaster can be
covered with film to provide additional protection against moisture ingress.
Should the available space in the upper arm socket be too small an area for the AxonMaster (lamination dummy)
must be reserved during lamination of the inner socket.
6.2.4 Sealing the prosthesis
1) After laminating the lamination ring, remove the grease and any dirt.
2) Lubricate the groove, inner edge and thread of the lamination ring with 633F30 Special Grease.
10
Preparing the product for use
AxonArm Ergo 12K501=*

6.2.5 Connecting the AxonMaster to the EasyPlug
1) Grease the plug of the AxonMaster cable with
633F11 silicone grease.
2) Connect the cable.
3) Apply 633F11 silicone grease around the plug and
blanking covers to seal.
6.3 Installing the EasyPlug
1) Lubricate the groove, inner edge and thread of the
lamination ring with 633F30 special grease.
2) Push the EasyPlug with the attached cable into the
lubricated lamination ring and press in firmly. The
EasyPlug enclosure must engage completely.
→You must be able to hear a loud click!
CAUTION
Misalignment of the EasyPlug during installation
> Injury due to faulty control or malfunction of the product.
> Reduction in mechanical strength due to thread misalignment.
►The circuit board and the edge of the lamination ring must be parallel to each other.
►Left picture:
The EasyPlug has been snapped in properly. The
circuit board and the edge of the lamination ring are
parallel to each other.
Right picture:
The EasyPlug has not been snapped in properly; it
is crooked. If the EasyPlug is extremely crooked (as
shown in the picture), you need to remove it and
insert it again because otherwise it may become
damaged.
6.4 Connecting the Elbow Joint to the Upper Arm
1) Unscrew the frictional clamp until the top thread is
lined up with the fixed thread (right picture).
2) Position the lamination ring on the upper arm sock
et such that the notch in the lamination ring is
across from the start of the thread.
11AxonArm Ergo 12K501=*
Preparing the product for use

3) Mark the base position for the flexion angle (preflex
ion) on the joint ball. DimensionY = 1.5cm.
4) Thread the belt under the axis.
5) Pull the belt up to the marking (dimension Y) with
tweezers.
6) Twist the forearm to the upper arm socket until the
notch on the lamination ring is visible above the
guide of the strap clamp (left picture). Otherwise
the strap clamp will not be able to be inserted (right
picture).
INFORMATION: Ensure the strap is straight and
not twisted.
7) Slide the strap clamp under the lamination ring.
8) Screw the strap clamp in.
6.5 Setting the Preflexion
• The level of AFB compensation (flexion assistance) can be adjusted and adapted to the weight of different
clothing with the dial. Adjustments are easier to make when the forearm is flexed.
• The adjustment mechanism is protected by a slip coupling.
• The hydrodynamic damper of the flexion aid mechanism is designed to counterbalance the weight of the fore
arm plus Axon-Bus gripping component. Please be sure to stabilise the upper arm component of the AxonArm
Ergo while testing the joint functions.
12
Preparing the product for use
AxonArm Ergo 12K501=*

Region 1
Minimal compensation that allows natural free swing of
the arm while walking.
Region 2
Compensation increases progressively with flexion of
the arm and decreases during extension.
Region 3
Compensation remains constant. If set correctly, the
weight of the forearm is balanced by the compensation
and the elbow remains flexed.
Region 4
Reduced compensation until flexion stop.
CAUTION
Lock released during donning, doffing or storing of the extended arm
Injury due to sudden bending of the forearm or the upper arm socket due to released lock.
►The Axon-Bus prosthethic system must always be flexed for donning and doffing.
►The Axon-Bus prosthethic system must be stored in flexed condition.
CAUTION
Release of lock when arm horizontal or raised vertically
►Injury due to sudden bending of the arm due to released lock and lack of a load, especially with a high com
pensation force setting.
→Inform the patient of this danger.
1) Flex the AxonArm Ergo and minimise the compens
ation force using the dial.
2) Flex the AxonArm Ergo until a loop can be made in
the strap using your finger (approx. 45°) and lock
the joint using the pull cable.
13AxonArm Ergo 12K501=*
Preparing the product for use

3) Secure the strap (e.g. using an artery clamp).
INFORMATION: When using an artery clamp,
verify that the jaws of the artery clamp have no
sharp edges. Otherwise, tape over the jaws to
protect the strap.
4) Loosen the screw on the strap clamp, but do not
remove the strap clamp.
5) Shorten or lengthen the strap.
Lengthening the strap: preflexion is decreased.
Shortening the strap: preflexion is increased.
6) Tighten the screw on the strap clamp.
7) Remove the strap securing device (artery clamp).
A 3 mm change in the strap length results in an approx.
5° change in the flexion angle (preflexion).
The free swing range is changed by the same amount
as the flexion angle. The start of the adjacent compens
ation region changes accordingly.
The factory-set preflexion is approx. 10°.
6.6 Adjusting the Humeral Rotation Feature
►The humeral rotation turntable has integral stops
(+/- 80 degrees) to block extreme movements.
Turntable friction is easily adjusted by turning of the
external adjustment screw, using a coin or similar
object.
6.7 Installing the Pull Cable
CAUTION
Removing the pull cable
Injury due to malfunction of the product.
►The pull cable on the 12K501 AxonArm Ergo is to be used for emergency operation only. For safety reasons, it
must not be removed. When the Axon-Bus prosthethic system is switched off or defective and when the bat
tery is empty, the AxonArm cannot be locked or unlocked without the pull cable.
1) Bring the forearm into neutral position (no outward
or inward rotation).
2) Affix the cable guide to the socket with cap screws
(centred in relation to the strap clamp and approx.
30 mm away from the lamination ring).
3) Test inward and outward rotation of the socket up to
the stop. Ensure that the pull cable cannot be ten
sioned (loop).
6.8 Checking the Symmetry
1) Connect the Axon-Bus gripping component (e.g. Michelangelo Hand) to the AxonArm.
2) Check the symmetry with respect to the other hand (e.g. using the 743L20=230 Ottobock Laser-Line).
14
Preparing the product for use
AxonArm Ergo 12K501=*

7 Handling
7.1 Charging the Battery
The 757B501 AxonEnergy Integral must be charged prior to initial use. The 757B501 AxonEnergy Integral may
only be charged with the 757L500 AxonCharge Integral. The charging process can only be performed with the
13E500 AxonMaster connected.
1) Connect the charging plug of the 757L500 AxonCharge Integral to the charging receptacle.
→The beeper sounds briefly 2x.
→The Axon-Bus prosthethic system is deactivated and the charging process starts automatically.
2) To activate the Axon-Bus prosthethic system, disconnect the charging plug and switch on the Axon-Bus pros
thethic system.
INFORMATION: The prosthesis cannot be used during the charging process.
The product is powered by an integrated high-quality Li-Ion battery with sufficient capacity to operate for one full
day of usual everyday activities. Turning the product off during longer periods of passive use (e.g. air or rail travel,
visit to a theatre or cinema, etc.) will make the battery last longer. We recommend charging the product once a day
when used by the patient on a daily basis. Electronic battery management provides the patient with information
about the battery charge level (battery management).
The charging unit consists of the charging plug and the power cord. The battery charger has an input voltage
range of 100–240V and may be operated in a mains frequency range of 50–60Hz.
7.2 Charging Receptacle
The charging receptacle (Fig. 1, item 2) has the following functions:
• Contacts for charging the battery
• LED display to indicate the current battery charge level
• LED display for providing feedback on operating states
• Button to turn the Axon-Bus prosthetic system on and off, display the battery charge level and open the Axon-
Bus gripping component in an emergency
• Beeper for providing feedback on operating states
• Button for activating the Bluetooth function.
7.3 Determining the Battery Charge Level
The battery charge level can be queried at any time.
1. With the Axon-Bus prosthetic system switched on, press the charging receptacle button (Fig. 2, arrow) and
hold for less than one second.
2. The LED is illuminated. The colour of the LED indicates the current battery charge level.
Battery empty Orange LED is illuminated
Battery 50% charged Yellow LED is illuminated
Battery fully charged Green LED is illuminated
7.4 Switching On the Axon-Bus Prosthetic System
►Press the charging receptacle button and hold for one second (Fig. 2, arrow).
→The beeper emits two short signals.
7.5 Switching Off the Axon-Bus Prosthetic System
►Press the charging receptacle button and hold for more than one second (Fig. 2, arrow).
→The beeper emits one long signal.
7.6 Safety Shutoff
The purpose of the safety shutoff is to protect the battery; it is triggered in case of:
• Excessively high or low temperature
• Overvoltage or undervoltage
• Short circuit.
After a short circuit the battery charger must be connected and then disconnected in order for the electronics to be
activated.
15AxonArm Ergo 12K501=*
Handling

7.7 Open the Axon-Bus Gripping Component in an Emergency
This safety function allows the Axon-Bus gripping component to be opened regard
less of the control signals present.
1) With the Axon-Bus prosthetic system switched on, press the charging receptacle
button and hold for approximately three seconds until the Axon-Bus gripping
component begins to open. A pulsating beep sounds as it opens.
2) Releasing the button immediately stops the process of opening the Axon-Bus
gripping component and turns the entire Axon-Bus prosthetic system off.
7.8 Bluetooth Function
Pressing the button in the charging receptacle and holding for more than four seconds with the Axon-Bus prosthet
ic system turned off activates the Bluetooth function of the connected AxonMaster 13E500. The blue LED lights up.
Once a connection to the PC has been successfully established, the LED flashes blue.
7.9 Beep Function
Action Beep
1x long
Beep
2x short
Beep
3x short
Beep
1x short, 1x
long
Beep
Pulsating
Turn the Axon-Bus pros
thesis solution on
Push the button for one to
four seconds.
Turn the Axon-Bus pros
thesis solution off
Push the button for more
than one second.
Charge the Axon-Bus
prosthesis solution
Connect the charging
plug, charging begins.
Stop charging
Disconnect the charging
plug. Charging ends and
the Axon-Bus prosthesis
solution is switched off.
Empty battery indicator
Turn Bluetooth function
on (if the Axon-Bus pros
thesis solution was previ
ously switched off)
Push the button for more
than four seconds.
Emergency opening of
the Axon-Bus terminal
device
Push and hold the button
for about three seconds
until the Axon-Bus terminal
device opens.
7.10 Data transfer between the product and the PC
Product settings using the adjustment software can only be made via Bluetooth data transfer. For this purpose, a
Bluetooth wireless connection must be established between the product and the PC using the “60X5=* BionicLink
PC” Bluetooth adapter. The installation and use of the “60X5=* BionicLink PC” adapter are described in the
instructions for use included with the adapter.
16
Handling
AxonArm Ergo 12K501=*

8 Legal information
All legal conditions are subject to the respective national laws of the country of use and may vary accordingly.
8.1 Liability
The manufacturer will only assume liability if the product is used in accordance with the descriptions and instruc
tions 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 unauthorised modification of the product.
8.2 Trademarks
All product names mentioned in this document are subject without restriction to the respective applicable trade
mark 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.
8.3 CE conformity
Otto Bock Healthcare Products GmbH hereby declares that the product is in compliance with applicable European
requirements for medical devices.
The product meets the requirements of the RoHS Directive 2011/65/EU on the restriction of the use of certain haz
ardous substances in electrical and electronic devices.
This product meets the requirements of the 2014/53/EU directive.
The full text of the regulations and requirements is available at the following Internet address:
http://www.ottobock.com/conformity
8.4 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 harm
ful 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.
This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic
Development Canada’s licence-exempt RSS(s)..
Operation is subject to the following two conditions:
(1) This device may not cause interference.
(2) This device must accept any interference, including interference that may cause undesired operation of the
device.
L’émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d’Innovation, Sci
ences et Développement économique Canada applicables aux appareils radio exempts de licence. L’exploitation
est autorisée aux deux conditions suivantes:
(1) L’appareil ne doit pas produire de brouillage;
17AxonArm Ergo 12K501=*
Legal information

(2) L’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en com
promettre le fonctionnement.
Caution: Exposure to Radio Frequency Radiation.
The installer of this radio equipment must ensure that the antenna is located or pointed such that it does not emit
RF field in excess of Health Canada limits for the general population.
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.
9 Technical data
Ambient conditions
Storage (with and without packaging) +5°C/+41°F to +40°C/+104°F
Max. 85%relative humidity, non-condensing
Transport (with and without packaging) -20°C/-4°F to +60°C/+140°F
Max. 90% relative humidity, non-condensing
Operation -5°C/+23°F to +45°C/+113°F
Max. 95% relative humidity, non-condensing
Charging the battery +5°C/+41°F to +40°C/+104°F
Max. 85%relative humidity, non-condensing
General AxonArm Ergo
Reference number 12K501=*
Dimensions [mm] Approx. 345mm x d55mm to d80mm (arm extended)
Weight without Axon-Bus terminal device [g] Approx. 840
Forearm length as delivered [mm] 305
Minimum adjustable forearm length [mm] 187
Flexion angle 15 °–145°
Maximum vertical load with locked elbow joint and a
forearm length of 305mm [kg]
23
Expected lifetime given compliance with service inter
vals [years]
5
Operating time with full charge Approx. 2500 gripping and locking cycles or approx.
8hours
Rechargeable battery lifetime [years] 2
Charging time [h] 3.5
10 Appendices
10.1 Symbols Used
Declaration of conformity according to the applicable European directives
In some jurisdictions it is not permissible to dispose of these products with unsorted household
waste. Disposal that is not in accordance with the regulations of your country may have a detri
mental impact on health and the environment. Please observe the instructions of your national
authority pertaining to return and collection.
Serial number (YYYY WW NNN)
YYYY – year of manufacture
WW – week of manufacture
NNN – sequential number
Medical device
18
Technical data
AxonArm Ergo 12K501=*

Manufacturer
10.2 Fault Display and Fault Elimination
10.2.1 LED flashes red and beeper sounds for 3 seconds
Probable cause: Error in the Axon-Bus prosthetic system.
Remedy: 1. Switch the Axon-Bus prosthetic system off and back on.
2. Check the plug connections in the socket.
3. Connect the charger. If the charger displays the service symbol (yellow spanner) or the
system error symbol (red spanner) send the Axon-Bus prosthetic system to Ottobock Myo-
Service.
10.2.2 The LED flashes three times after pressing the button in the colour of the current battery
capacity
Probable cause: The connection from the AxonEnergy Integral to the Axon-Master has been interrupted.
Remedy: 1. Check the connection (e.g. plug connections, flex cable, EasyPlug etc.).
2. If no fault can be found, send the Axon-Bus prosthetic system to Ottobock Myo-Service.
10.2.3 LED alternately flashes yellow/red and beeper sounds for 3 seconds
Probable cause: The Axon-Bus prosthetic system is overheated.
Remedy: 1. Allow the Axon-Bus prosthetic system to cool for a few minutes.
2. Do not use the Axon-Bus prosthetic system at high ambient temperatures.
10.2.4 The movements of the Axon-Bus gripping component are becoming increasingly slower
The patient is alerted to the diminishing battery charge level as the Axon-Bus gripping component increasingly
slows down and the gripping force decreases. Finally, when there is very little battery capacity remaining, the
Axon-Bus prosthetic system switches off automatically to protect the battery against harmful deep discharge.
10.3 Axon
The term "Axon" stands for Adaptive eXchange Of Neuroplacement data. The Axon-Bus is an Ottobock innovation
for the field of exoprosthetics: a data transmission system, derived from safety-related bus systems in the aviation
and automobile industries. For the user this means enhanced safety and reliability because of a considerably
reduced sensitivity to electromagnetic interference in comparison with conventional systems.
19AxonArm Ergo 12K501=*
Appendices

Template-Version: SB_2021-02· FM483 · SB_210x297
Otto Bock Healthcare Products GmbH
Brehmstraße 16 · 1110 Wien · Austria
T [phone] · F [phone]
[email protected] · www.ottobock.com
© Ottobock · 647G790-0=en_INT-08-2208