FIOR & GENTZ NEURO HiTRONIC User manual

Instructions for Use for Patients
NEURO HiTRONIC EN

2
Content Page
EN
Instructions for Use for PatientsAutomatic Electronic System Knee Joints 4
1. Safety Instructions 4
1.1 Classification of the Safety Instructions 4
1.2 All Instructions for Your Safety 4
2. Use 7
2.1 Intended Use 7
2.2 Indication 7
2.3 Contraindication 7
2.4 Qualification 7
2.5 Application 7
3. Knee Joint System 8
3.1 Joint Functions 9
3.1.1 Safe Handling of the Joint Functions 9
3.1.2 Basic Function in Auto Mode 10
3.1.3 Alternative Function in Lock Mode 10
3.1.4 Alternative Function in Free Mode 10
3.1.5 Alternative Function in Permanent Unlocking 10
3.2 Rotary Switch 11
3.3 The Remote Control 11
3.4 The User App 12
3.4.1 Step Counter 12
3.5 The Controller 12
3.6 Manual Mode Change 13
4. Connection between Controller and Remote Control/App 13
4.1 Controlling Two Orthoses 13
5. Checking the Connection between Controller and Remote Control 13
5.1 Indication of the Connection with one Controller 14
5.2 Indication of the Connection with two Controllers 15
6. Checking the Connection between Controller and User App 15
7. Checking the Mode and Battery Status 16
7.1 Indication of mode and battery status on the controller 16
7.2 Indication of Battery Status on the Remote Control/in the App 16
7.2.1 Indication of the Battery Status for a Connection with one Controller 17
7.2.2 Indication of the Battery Status for a Connection with two Controllers 17
8. Energy Consumption 18
8.1 Period of Use of Batteries in Dierent Modes 18
8.2 Energy-Saving Modes 18

3
9. Handling of the Battery in the Controller 19
9.1 Charging the Lithium-Polymer Battery 19
10. Advice on Using Your Orthosis 19
10.1 Before Use 19
10.2 Bluetooth Connection 19
10.3 The Proper Shoe 19
10.4 Gait Re-Education 20
10.4.1 Walking with the Orthosis in Auto Mode 20
10.5 Malfunction Due to External Impact 21
10.6 Restrictive Use 21
11. Maintenance of the Orthosis 21
11.1 Dirt Removal from the System Joint 22
12. Storage 22
13. Advice on Optimal Orthosis Functionality 22
13.1 System Knee Joint 22
13.2 Remote control 22
13.3 Controller 23
14. Disposal 23
15. Technical Data 23
15.1 Ambient Conditions 23
16. Signs and Symbols 25
17. CE Conformity 27
18. Legal Information 27
19. Electromagnetic Compatibility 28
19.1 Electromagnetic Environment 28
19.2 Electromagnetic Emissions for all Devices and Systems 28
19.3 Electromagnetic Immunity for all Devices and Systems 29
19.4 Electromagnetic Immunity for Non-Life-Supporting Devices and Systems 30
19.5 Recommended Safety Distances between Portable and Mobile RF Telecommunication
Equipment and the Product NEURO HiTRONIC for Non-Life-Supporting Devices and
Systems 31
20. Handing Over the Orthosis 32

4
Instructions for Use for Patients
NEURO HiTRONIC System Knee Joint
Dear Patient,
You have received an individually produced orthosis with a high quality FIOR&GENTZ automatic electronic
system knee joint from your orthotist or a qualified/trained expert.
1. Safety Instructions
1.1 Classification of the Safety Instructions
DANGER Important information about a possible dangerous situation which, if not avoided,
leads to death or irreversible injuries.
WARNING
Important information about a possible dangerous situation which, if not avoided,
leads to reversible injuries that need medical treatment.
CAUTION Important information about a possible dangerous situation which, if not avoided,
leads to light injuries that do not need medical treatment.
NOTICE Important information about a possible situation which, if not avoided, leads to
damage of the product.
All serious incidents according to Regulation (EU) 2017/745 which are related to the product have to be
reported to the manufacturer and to the competent authority of the Member State in which the orthotist and/
or the patient is established.
1.2 All Instructions for Your Safety
DANGER
Potential Trac Accident Due to Limited Driving Ability
Gather information about all issues concerning safety and security and potential dangers before driving a
motor vehicle with orthosis.
DANGER
Risk of Strangulation Due to Improper Handling of the Cable
Use the orthosis as described in these instructions for use. During use, pay special attention to the con-
necting cable of the orthosis as well as to the charging cable of the controller.
Instructions for Use for Patients
Automatic Electronic System Knee Joints

5
WARNING
Jeopardising the Therapy Goal by Not Providing the Necessary Free Movement
Check if the system joint moves freely in order to avoid restrictions of the joint function.
WARNING
Risk of Falling Due to Permanent Higher Load
Do not engage in any sports with the orthosis that expose it to excessive strain. If your patient data has
changed (e.g. due to weight gain, growth or increased activity), consult your orthotist or a qualified/trained
expert and have them check the suitability of your orthosis with regard to the changed load. You will find
the next maintenance appointment in your orthosis service passport.
WARNING
Risk of Falling Due to Improper Shoe/Wrong Shoe Pitch
Wear a shoe to which your orthosis is adjusted to avoid joint dysfunction.
WARNING
Risk of Falling Due to Improper Handling
Have your orthotist or a qualified/trained expert inform you about the correct use of the system joint.
Disable the permanent unlock function if you no longer wish to use it.
WARNING
Risk of Falling Due to Improper Dirt Removal
In order to avoid a failure of the lock function, remove dirt from the orthosis and the system joint as
described in these instructions for use. Do not grease the system joint on your own. If necessary, consult
your orthotist or a qualified/trained expert.
WARNING
Risk of Falling Due to Damages to the Orthosis
Avoid damage to your orthosis and to the integrated electronics (e. g. due to shocks, knocks and fall). If
your orthosis is still damaged, switch it to Lock mode and contact your orthotist or a qualified/trained
expert as soon as possible.
WARNING
Risk of Falling Due to Walking Incorrectly with the Orthosis
Consult your orthotist or a trained/qualified expert about the correct use of your orthosis and the particu-
larities of the system joint. If necessary, we recommend a physiotherapeutic gait re-education.

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WARNING
Risk of Falling Due to Modified Orthosis Settings
If you notice any changes in the orthosis (e.g. loosely attached joint components, loosened screws, play
in the system joint or change in performance), immediately contact your orthotist or a qualified/trained ex-
pert. Do not secure the screws for the system joint on your own. The adjustments must be checked by your
orthotist or a qualified/trained expert before handing over the orthosis and at every maintenance. You will
find the next maintenance appointment in your orthosis service passport.
WARNING
Risk of Injury Due to Improper Handling of the Controller or Remote Control
Use the controller and the remote control as described in these instructions for use. The orthosis may not
be worn while it is charging. The controller is a sensitive electronic device with an integrated lithium-pol-
ymer battery. When handling the controller please avoid:
- strong heat (e.g. fire, heater, fireplace),
- charging a battery in direct sunlight,
- knocks and shocks (e.g. by pets) as well as
- immersion in water.
WARNING
Risk of Injury Due to Improper Handling of the System Joint
Use the system joint as described in these instructions for use.
- Do not immerse the system joint in water. The electronic system components (excluding the accessories)
are only protected from water splashing on all sides.
- When using the system joint, an opening is formed between the joint’s upper and lower parts, in which
clothing or skin could get caught.
NOTICE
Limitation of Joint Function Due to Electrostatic/Magnetic Field
Please note that, while using the orthosis, an electromagnetic and magnetic field (e.g. MRI) can lead to
joint dysfunction.
NOTICE
Limitation of the Joint Function Due to Lack of Maintenance
Have your orthotist or a qualified/trained expert inform you about the maintenance intervals to be
observed in order to avoid joint dysfunctions. You will find the next maintenance appointment in your
orthosis service passport.
NOTICE
Damage to Controller Due to Improper Handling
Use the controller as described in these instructions for use. In particular, please ensure that the control-
ler:
- is used with the provided charging cable and power supply unit, and
- is only used at ambient temperatures from -10°C to +40°C.

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NOTICE
Damage to Controller and Remote Control Due to Improper Handling
Ensure the correct use in order to avoid joint dysfunction. Avoid:
- to open the controller and the remote control as well as
- using them in areas where radio waves are forbidden (e.g. in planes, hospitals).
Ask the responsible sta on-site about using the controller and remote control.
2. Use
2.1 Intended Use
The FIOR & GENTZ electrohydraulic system knee joints are exclusively for use for orthotic fittings of the lower
extremity. The system joint provides stance phase control and is only allowed to be used for producing a KAFO
(knee-ankle-foot orthosis). Every system joint influences the orthosis’ function and thus also the function of
the leg.
2.2 Indication
The indications for the treatment with an orthosis for the lower extremity are insecurities that lead to a
pathological gait. This can be caused, for example, by central, peripheral, spinal or neuromuscular paralyses,
structurally conditioned deformities/malfunctions, or surgery.
The physical conditions of the patient, such as muscle strength or activity level are crucial for the orthotic
treatment. A safe handling of the orthosis must be ensured. The orthotist or qualified/trained expert selects
the appropriate system joints for the orthosis.
2.3 Contraindication
The system joint is not suitable for treatments that were not described in paragraph 2.2, such as a treatment
of the upper extremity or a treatment with a prosthesis or ortho-prosthesis, for example after amputations of
leg segments.
2.4 Qualification
The system joint must only be handled by an orthotist or a qualified/trained expert.
2.5 Application
All FIOR & GENTZ system joints were developed for everyday life activities such as standing and walking. Ex-
treme loads connected to activities like running, climbing and parachuting are excluded. The system joint can
be used at temperatures of -10°C to +40°C.
Any modification of the system joint from your side is not permitted.
In case of problems with the system joint and potentially occurring allergic reactions, contact your
orthotist or a qualified/trained expert or the manufacturer. You can find the manufacturer’s contact
data on the back page of these instructions for use.

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3. Knee Joint System
The knee joint system is equipped with Bluetooth® technology* and consists of the following components
(fig.1):
system knee joint
controller
remote control for the patient including charging cable with adapter and User app
Expert app for the orthotist or the qualified/trained expert
The system knee joint and the controller are built into your orthosis. The orthotist or qualified/trained expert
uses the Expert app to adjust the orthosis. You need the remote control to operate the orthosis. In addition,
you can also use the User app.
* The Bluetooth® word mark and logos are registered trademarks of Bluetooth SIG, Inc. and any use of these
marks by FIOR&GENTZ is under license.
1
2
3
4
Fig. 1
remote control
User app
controller
PATIENT
system knee joint
ORTHOTIST
1
2
3
3
3charging cable
and adapter
4
Expert
app

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Your orthotist or a trained/qualified expert has provided you with the following system components in addition
to your orthosis (fig. 2):
Item Art. No. Description Unit Quantity
1 ET0710-01 charging cable pce. 1
2 PR4000 FIOR &GENTZ lanyard pce. 1
3 ET3840-P remote control pce. 1
4 ET0780 adapter pce. 1
3.1 Joint Functions
The NEURO HiTRONIC is a microprocessor-controlled, automatic system knee joint and provides four joint
functions:
-basic function in delivery status in Auto mode
-alternative function in Lock mode
-alternative function in Free mode
-alternative function in permanent unlocking
The essential performance features of the automatic electronic system joint are to remain unlocked in Free
mode and locked in Lock mode, as well as to lock or unlock at the right moment in Auto mode.
3.1.1 Safe Handling of the Joint Functions
Stance Phase Control
The system joint ensures the infinitely variable stance phase in a knee angle of 0° (5°) to 45°. Stance phase
control occurs between 45° and 50° contingent upon the load. If the load limit is exceeded, an overload pro-
tection takes eect. It is comparable to an electric fuse. If the overload protection is triggered, this may result
in deformation of the roll holder and possibly its fracture. In this case, the roll unit must be replaced by your
orthotist or a qualified/trained expert.
Standing Up From a Seated position
Before standing up, the system knee joint must be set to Free mode. Once you are standing securely,
you can switch to Auto or Lock mode.
Fig. 2
1 4
2 3

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3.1.2 Basic Function in Auto Mode
The controller of the orthosis has motion sensors that detect the movement and position of
your lower leg. The controller locks and unlocks the system joint depending on which gait
phase you are in.
Stance
When you are standing with your orthosis (fig.3) or when you interrupt the step in stance
phase, the NEURO HiTRONIC system knee joint locks, as no movement is registered.
Gait
When walking, the system joint locks/unlocks as follows: The system joint is locked in the direction of flexion
from mid swing to mid stance. In the gait phases from terminal stance to initial swing, the system joint is
unlocked and is therefore free moving (fig.4).
3.1.3 Alternative Function in Lock Mode
In Lock mode, the system knee joint is a locked joint that prevents a flexion of the leg. An extension remains
possible.
3.1.4 Alternative Function in Free Mode
In Free mode, the system knee joint is an unlocked joint that is free moving up to a determined position.
3.1.5 Alternative Function in Permanent Unlocking
The system knee joint can be permanently unlocked mechanically, for example for activities such as driving a
car or bicycle. In this mode it is guaranteed that the system knee joint will not lock unintentionally.
To do so, take a seat and unlock the system joint manually with the rotary switch below the system joint, by
pressing in the rotary switch and then turning it in the direction of the symbol.
If, contrary to expectations, you put weight on the leg with orthosis during the free moving phases, the
system joint will not lock.
DE
GB
ES
FR
NL
IT
GELENKRELEVANTE GANGPHASEN IN e-MOTION
Initial contact Loading response Mid stance Terminal stance Pre swing Swing phaseTerminal swing
gesperrt
Stand
gesperrt gesperrt gesperrt gesperrt frei beweglich frei beweglich frei beweglich
IM STEHEN
JOINT RELEVANT GAIT PHASES IN e-MOTION
Initial contact Loading response Mid stance Terminal stance Pre swing Swing phaseTerminal swing
locked locked locked locked
Stance
locked
free moving free moving free moving
STANDING
GB
NEURO TRONIC：関節に関係する歩行段階
初期接地 荷重応答期 立脚中期 立脚終期 前遊脚期 遊脚期遊脚終期
ロック ロック ロック ロック
立脚
ロック 自由運動 自由運動 自由運動
立位
Initial contact Loading response Mid stance Terminal stance Pre swing Swing phaseTerminal swing
BloqueadaBloqueada Bloqueada Bloqueada Bloqueada De movimiento libre De movimiento libre De movimiento libre
PHASES DE MARCHE ESSENTIELLES POUR L‘ARTICULATION EN e-MOTION
Initial contact Loading response Mid stance Terminal stance Pre swing Swing phaseTerminal swing
Verrouillée
Phase d‘appui
Verrouillée Verrouillée Verrouillée Verrouillée À mouvement libre À mouvement libre À mouvement libre
DEBOUT
GEWRICHTSRELEVANTE GANGFASEN IN e-MOTION
Initial contact Loading response Mid stance Terminal stance Pre swing Swing phaseTerminal swing
vergrendeld
Standfase
vergrendeld vergrendeld vergrendeld vergrendeld vrij beweeglijk vrij beweeglijk vrij beweeglijk
BIJ STILSTAAN
NO
LEDDRELEVANTE GANGFASER MED e-MOTION
Initial contact Loading response Mid stance Terminal stance Pre swing Swing phaseTerminal swingStand
Låst
FASI DI DEAMBULAZIONE RILEVANTI PER L‘ARTICOLAZIONE IN e-MOTION
Initial contact Loading response Mid stance Terminal stance Pre swing Swing phaseTerminal swing
bloccata
Fase d‘appoggio
bloccata bloccata bloccata bloccata libertà di movimento libertà di movimento libertà di movimento
IN POSIZIONE ERETTA
DE PIE
Fase de apoyo
FASES DE LA MARCHA RELEVANTES PARA LA ARTICULACIÓN EN e-MOTION
Låst Låst Låst Låst Fritt bevegelig Fritt bevegelig Fritt bevegelig
STÅENDE
Fig. 3
Fig. 4
DE
GB
ES
FR
NL
IT
NEURO HiTRONIC: GELENKRELEVANTE GANGPHASEN
Initial contact Loading response Mid stance Terminal stance Pre swing Initial swingTerminal swing
gesperrt
Stand
gesperrt gesperrt gesperrt gesperrt
Mid swing
gesperrtfrei beweglich frei beweglich frei beweglich
lockedfree moving
BloqueadaDe movimiento libre
VerrouilléeÀ mouvement libre
vergrendeldvrij beweeglijk
bloccatalibertà di movimento
LåstFritt bevegelig
IM STEHEN
NEURO HiTRONIC: JOINT RELEVANT GAIT PHASES
Initial contact Loading response Mid stance Terminal stance Pre swingTerminal swing
locked locked locked locked
Stance
locked
free moving free moving
STANDING
Initial contact Loading response Mid stance Terminal stance Pre swingTerminal swing
BloqueadaBloqueada Bloqueada Bloqueada Bloqueada De movimiento libre De movimiento libre
NEURO HiTRONIC: PHASES DE MARCHE ESSENTIELLES POUR L‘ARTICULATION
Initial contact Loading response Mid stance Terminal stance Pre swingTerminal swing
Verrouillée
Phase d‘appui
Verrouillée Verrouillée Verrouillée Verrouillée À mouvement libre À mouvement libre
DEBOUT
NEURO HiTRONIC: GEWRICHTSRELEVANTE GANGFASEN
Initial contact Loading response Mid stance Terminal stance Pre swingTerminal swing
vergrendeld
Standfase
vergrendeld vergrendeld vergrendeld vergrendeld vrij beweeglijk vrij beweeglijk
BIJ STILSTAAN
NO
NEURO HiTRONIC: LEDDRELEVANTE GANGFASER
Initial contact Loading response Mid stance Terminal stance Pre swingTerminal swingStand
Låst
NEURO HiTRONIC: FASI DI DEAMBULAZIONE RILEVANTI PER L‘ARTICOLAZIONE
Initial contact Loading response Mid stance Terminal stance Pre swingTerminal swing
bloccata
Fase d‘appoggio
bloccata bloccata bloccata bloccata libertà di movimento libertà di movimento
IN POSIZIONE ERETTA
DE PIE
Fase de apoyo
NEURO HiTRONIC: FASES DE LA MARCHA RELEVANTES PARA LA ARTICULACIÓN
Låst Låst Låst Låst Fritt bevegelig Fritt bevegelig
STÅENDE
Initial swing Mid swing
Initial swing Mid swing
Initial swing Mid swing
Initial swing Mid swing
Initial swing Mid swing
Initial swing Mid swing

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Fig. 5
If you then press the lock button on the remote control/app, you also save energy.
The system knee joint remains unlocked even if you select another mode (e.g. Auto)
with the remote control/app. In order to change the system joint’s mode again with
the remote control/app, turn the rotary switch in the direction of the symbol
(fig.5).
3.2 Rotary Switch
There is a rotary switch below the system joint (fig. 5). The three symbols show what
happens if the rotary switch is turned in their respective direction. The arrows below
show how the rotary switch should be controlled in order to select a symbol.
Symbol Action Meaning
Turn the rotary switch in the
direction of the symbol The system joint is operated from the remote control/app.
Turn the rotary switch in the
centre and press in
The system joint is unlocked as long as the rotary switch is
pressed in. As soon as it is released, the system joint will be
operated once again from the remote control/app.
Press in the rotary switch and
turn it in the direction of the
symbol
The system joint is now in permanent unlocking (see para-
graph 3.1.5).
3.3 The Remote Control
You can select the mode on your orthosis with the remote control. Make sure that you are standing secure-
ly when changing the mode of your orthosis. Every time you press a button on the remote control, the LED
flashes briefly.
Remote Control Item Description Meaning
2
4
3
11 LED The LED indicates light signals for the selected
mode and the battery health.
2 Auto button The system joint switches into Auto mode.
3 Free button The system joint switches into Free mode.
4 Lock button The system joint switches into Lock mode.
Handle the remote control properly. If your remote control does not work as usual, do not try to open it. Con-
sult your orthotist or a qualified/trained expert.

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3.4 The User App
The app is intended to complement your remote control. It oers the same range of
functions.
You can operate the orthosis either with the remote control and/or with the free app
(fig. 6) via your smartphone/tablet or your Apple Watch* (fig.7). Minimum requirements are
Bluetooth 4.0 and Android 6.0 or iOS 10.
* Apple Watch is a trademark of Apple Inc., registered in the U.S. and other countries.
3.4.1 Step Counter
The app gives you access to the step counter, which counts all steps you take with the leg
with orthosis in the dierent modes. If you would like to know how many steps you have
taken in total (with both legs), double the value.
3.5 The Controller
The controller is mounted to your orthosis. It receives commands from the remote control/app, registers your
movements and controls the system knee joint.
Controller with Integrated
Lithium-Polymer Battery Item Description
1
multicolour LED display for battery
charging, mode and Bluetooth connec-
tion
2 MODE button
3 charging connection
The orthosis can only be operated with remote control or app to which it is
currently connected. Other remote controls/apps have no influence on your orthosis.
Fig. 6
Fig. 7
2
3
1

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3.6 Manual Mode Change
A MODE button, through which the orthosis can be operated manually, is built into the controller.
Depending on the mode that is already selected, it can be set in the following order: Auto, Free and Lock. This
button is particularly important if you are travelling by plane, as it is possible that you may not be allowed
to use the remote control/app during take-o, final approach or landing. You are allowed to use the remote
control/app during the flight and after landing.
4. Connection between Controller and Remote Control/App
The connection between the controller and the remote control is established by your orthotist or a qualified/
trained expert. If you wish to operate the controller with the User app, use the app menu and select the
desired menu item to establish a connection. Follow the additional instructions in the app.
4.1 Controlling Two Orthoses
If you are wearing two orthoses with a NEURO HiTRONIC knee joint system, you have the option of connect-
ing the controllers of both orthoses with one or two remote controls. If you activate two remote controls, you
can change the modes separately for each controller/orthosis. If you activate only one remote control, the
modes of both controllers/orthoses are changed simultaneously. You can change the modes for both control-
lers or orthoses separately or at the same time, with the User app.
5. Checking the Connection between Controller and Remote Control
Due to signals of the controller and the remote control, you will be informed if your remote control is con-
nected with the controller. The LED at the remote control indicates that the remote control and the controller
communicate with each other. There are dierent signals for a connection with one or two controllers.
The MODE button can only be used as long as the battery is not fully discharged. When the battery is
fully discharged, you can only use the Lock mode.
If you have previously operated the orthosis with the app, you have to close the app in order to operate
the orthosis with the remote control.

14
5.1 Indication of the Connection with one Controller
Remote Control Light Signal Meaning
One of the three but-
tons was pressed.
colour: yellow, green, red (depending on
battery status)
The remote control is connected
with the controller. The command
was sent successfully.
signal duration:
colour: red - The orthosis is in Sleep mode (see
paragraph 8.2).
- The battery is empty.
- The remote control is too far from
the orthosis.
signal duration:
colour: blue (controller)
The controller communicates with
the remote control.
signal duration:

15
5.2 Indication of the Connection with two Controllers
Remote Control Light Signal Meaning
One of the three but-
tons was pressed.
colour: yellow, green, red (depending on
battery status) The remote control is connected
with the controllers. The com-
mand was sent successfully to an
orthosis.
signal duration:
colour: red - The orthoses are in Sleep mode
(see paragraph 8.2).
- The batteries are empty.
- The remote control is too far from
the orthoses.
signal duration:
colour: yellow, green, red (depending on
battery status) and afterwards red
The command was sent successfully
to an orthosis.
- The second orthosis is in Sleep
mode (see paragraph 8.2).
- The battery for the second ortho-
sis is empty.
- The remote control is too far from
the second orthosis.
signal duration: . . .
colour: blue (controller)
The controllers communicate with
the remote control.
signal duration:
6. Checking the Connection between Controller and User App
In order to operate the orthosis via the app, Bluetooth must be permanently switched on and the app must be
open in the foreground. Use the menu of the app and select the desired menu item to connect to one or two
controllers. Follow the additional instructions in the app.
An orthosis can only be operated with one app at the same time because there is a connection between the
controller and the app. Other apps have no influence on the connected orthosis. You can continue to use the
remote control instead of the app when the controller is connected to the remote control and is not actively
communicating with the app. If there is an active connection to the app, the blue LED on the controller blinks
permanently and the controller cannot be operated with the remote control. The app is intended to comple-
ment your remote control.

16
7. Checking the Mode and Battery Status
7.1 Indication of mode and battery status on the controller
You can see the mode and battery status of the controller on the remote control or in the app. Furthermore,
the LED battery level indicator displays the following light signals for the battery status:
Light Signal Meaning
colour: yellow, green, red (depending on battery
status) The controller is in Auto mode.
signal duration:
colour: yellow, green, red (depending on battery
status) The controller is in Free mode.
signal duration:
– The controller is in Lock mode.
The controller emits the following sounds for battery status when the battery is almost empty:
Sound Signal Signal Duration Cause Meaning
0.5 sec.
break
1 sec. 0.5 sec.
break
1 min. 0.5 sec.
break
1 sec. 0.5 sec.
The battery is
almost empty.
Depending on the
battery health,
it takes max.
3 hours to fully
discharge.
Due to the importance of a properly functioning orthosis, this signal sounds every minute. This period can be
extended to ten minutes by pressing one of the three mode buttons on the remote control/app. To do this,
select the mode in which your orthosis is currently operating so that you do not inadvertently change modes.
After ten minutes, the pause can always be extended by another ten minutes by pressing the mode button
again. If no mode button is pressed, the signal will sound every minute. The sound signals for the battery
status can be turned o until the next charge through the User app settings.
7.2 Indication of Battery Status on the Remote Control/in the App
If you operate the orthosis via the app, you can see the battery status of the controller(s) at any time in the
app.
You can also check the status of the batteries in the controller(s) with your remote control. There are dierent
signals for a connection with one or two controllers.
The battery status is not displayed in Lock mode. It can be viewed on the remote control or in the app.

17
7.2.1 Indication of the Battery Status for a Connection with one Controller
Light Signals for the Remote control (with Auto Mode Example):
Remote Control
Light Signal
Meaning
LED Colour Signal
Duration
One of the three but-
tons was pressed.
green
The battery for the
controller is fully
charged.
yellow
The battery status is
low. Depending on the
battery health, it takes
max. 7 hours to fully
discharge.
red
The battery is almost
empty. Depending on
the battery health, it
takes max. 3 hours to
fully discharge.
7.2.2 Indication of the Battery Status for a Connection with two Controllers
If your remote control is connected with two controllers, the light signal on the remote control does not apply
automatically to both controllers but to that with the lowest battery. The battery status indicator on the
controller or in the app (see paragraph7.1) allows you to determine whether the batteries of both controllers
are aected, or which orthosis requires its battery to be charged.
Example: The LED of the remote control flashes red, after you have pressed one of the three buttons.
The LED battery status indicator of the controller for the right orthosis blinks green, which means that the
battery is full. The LED battery status indicator of the controller for the left orthosis blinks red. This orthosis
should soon be charged.

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8. Energy Consumption
8.1 Period of Use of Batteries in Dierent Modes
The following average battery life was determined at room temperature:
Auto Free Lock
26 000 strides 24 hours over 2 weeks
8.2 Energy-Saving Modes
Your orthosis has three dierent energy-saving modes:
-If the orthosis is not moved in Auto or Free mode for more than two hours, the orthosis switches into
Lock mode automatically. The Lock mode saves energy. If you press any button on the remote control, the
orthosis will change back from Lock mode into the desired mode.
-If the orthosis is not moved for more than 30 minutes in Lock mode, it will automatically switch into Sleep
mode. In Sleep mode, the orthosis consumes very little energy. The controller no longer receives signals
from the remote control/app. To switch back into Lock mode, move the orthosis slightly. The LED on the
controller then lights up briefly in all colours.
-If the orthosis is not moved for more than 72 hours, it switches automatically into Deep Sleep mode. In
Deep Sleep mode the controller does not consume energy and no longer receives signals from the remote
control/app. In order to put the orthosis back in operation, press the MODE button on the controller or
connect the charging cable.
Using the remote control/app, switch the orthosis into Lock mode if you will not use it for a longer peri-
od of time. It will switch into Sleep mode after only 30 minutes and consume very little energy.

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9. Handling of the Battery in the Controller
The controller has a long service life and battery lifespan. Do not try to disassemble the controller as the
battery is a fixed part of the controller.
9.1 Charging the Lithium-Polymer Battery
You can charge the battery using the charging cable and power supply unit included in the scope of delivery,
via a common household power socket. Always charge the battery fully and respect the general conditions of
use and storage.
If the period of use of the orthosis is considerably shortened despite the fully charged battery, contact your
orthotist or a qualified/trained expert.
10. Advice on Using Your Orthosis
10.1 Before Use
Pay attention to the following every time you use the orthosis:
-Check the battery status of the controller.
-Set the orthosis in Free mode in order to put it on.
-Set the rotary switch to the symbol so that you can operate the system joint via the remote control/
app.
10.2 Bluetooth Connection
The connection quality depends on how interference-free your environment is.
10.3 The Proper Shoe
The orthotist or qualified/trained expert adjusts your orthosis when you try it on and make your first steps.
Since you have to get used to your new orthosis, the adjusted orthosis should be regularly checked in the first
weeks and, if necessary, newly adapted to your need for safety. The orthosis is adjusted to the pair of shoes
(shoe pitch) with which you start walking with your orthosis. If you want to wear other shoes, your orthotist
or a qualified/trained expert must ensure that the orthosis is also adjusted to these shoes.

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10.4 Gait Re-Education
In order to be able to use your orthosis optimally, you should make use of a physiotherapeutic gait re-educa-
tion.
In gait re-education, the following should be specially trained:
-walking upright, with the upper body slightly bent forward;
-applying as little body weight as possible on walking assistive devices (such as canes, parallel bars or walk-
ers) as otherwise the physiological gait can be affected.
With gait re-education, you become more secure in using your orthosis, your gait pattern improves and you get
used to your orthosis sooner. This is particularly important when a locked orthosis has been used before for
many years. Gait re-education can also be supported by acoustic signals from the orthosis. Ask your orthotist
or a qualified/trained expert for additional information. Be extremely careful when managing stairs, going
on uneven surfaces or uphill/downhill. If you do not feel secure in using your orthosis in Auto mode yet, we
recommend selecting Lock mode (see paragraph 3.1.3). Regularly report your experiences with the orthosis
during the first weeks to your orthotist or a qualified/trained expert . This is the only way you can get specific
advice or help.
10.4.1 Walking with the Orthosis in Auto Mode
The system knee joint unlocks during the first stride. The e-motion algorithm makes it possible for the motion
sensors of the controller to unlock the system knee joint at the right moment, when the second step is taken.
Therefore, it is not necessary to become accustomed to always taking the first step using the leg with the
orthosis. This leads to a more physiological gait pattern, especially when both legs are treated.
The more physiological the gait characteristics become, the better the orthosis can support you.