When spams or alteration of the tone are observed during the therapy on Armotion, it is
recommended to stop the therapy by pressing one of the emergency stop.
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**Upper limb spasticity reduction following active training: a robot-mediated study in patients with chronic hemiparesis”
Posteraro et al, Journal Rehabilitation Medicine 2010; 42: 279-281
3.3 General Hazards
Despite extensive risk analysis according to EN ISO 14971 remains a residual risk. A detailed risk
analysis of Reha Technology AG can be viewed up on request.
Injury risk by means of clamping and crushing!
Abidance in areas of mechanically moved parts implicates the injury risk of clamping or
crushing.
• Abidance in areas of mechanically moved parts is not allowed during device motion
operation.
3.4 Personnel Qualification
To guarantee the safety of the patient of the operator and the device itself, and in order to
guarantee safe and successful therapy on the patient, the use of Armotion is allowed only after
having carefully read this instruction manual.
Future operators should fulfil the prerequisite of having absolved a medical training (e.g.
Medicine, Physiotherapy and Occupational Therapy).
The user manual gives the operators an overview over the following topics:
• Device handling and use according to regulations including practical exercises
• Device and function principles
• Command settings
• Indications and recommended settings
• Contraindications and side effects
• Explanation of the maintenance operations carried out by operators (daily/monthly
control)
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The
Armotion
may only be
under the supervision of
a medical specialist
.
4 Specifications
The following section provides a general overview of the Armotion.
4.1 Specifications in Detail
Designation of Type: Armotion
Year of manufacture: 2014
Applicable Norms: EN ISO 13485:2012, ISO 9001:2008,
IEC 60601-1:2007, IEC 60601-1-2:2010,
IEC 60601-1-6:2010, IEC 62304:2006
ISO 14971:2012, EN 14155:2012, EN 10993-1:2010
Classification: CE class 2a
Type of application: rehabilitation of upper extremities
Country of Origin: Switzerland
Power Supply: 11.1 V DC, 10A
Highest permissible force: 40 N
4.2 Operating Conditions
Temperature: 15°, + 40 °C
Humidity: 0% - 75 % relative humidity
NOTICE
The stationing of the device is limited to clean, dry rooms.
NOTICE
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Explosion ha
zard
when used
in
areas of danger of explosion
!
The Armotion can provoke explosion by means of electric power supply components.
• The Armotion may not be used in areas of danger of explosion, zones AP and APG
according to IEC 60601-1:1990.
• The use of flammable and explosive anaesthetic inhalation agents or combinations
thereof is not permitted in the surroundings of the Armotion
4.3 FCC compliance
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.
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.
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5 Components
5.1 Overview
The ARMOTION system consists of the following parts:
• One Armotion
• One height adjustable table
• One rubber working surface with encoded optical tracks
• An emergency stop “fungus” (connected to the Armotion)
• Three different handles
• One PC and monitor (or all-in-one PC depending on the country of use)
• Two rechargeable battery packs
• One docking station for recharging the battery
• Optionally: one USB Bluetooth adapter and its extension if not integrated in the PC
Configuration of the Armotion System as a whole
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Arm support
Emergency stop
Connector for
Main Switch
Exchangeble handle
Emergency stop
Exchangeable
Counterweight
The working surface provides an optical encoding allowing the Armotion to find its position at
any time. The working surface is also equipped with safety edges to prevent accidental falls of
the Armotion.
On-off
external safety
switch
The patient's arm is resting on the support (Picture 3) and stabilized with the Velcro straps
provided. The patient interacts with the system by grasping the one of the provided handle.). A
force sensor detects the intensity and the direction of the force exerted by the user.
battery
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Safety precautions
• Do not lift the Armotion by gripping it from the front part
For safety reason, the robot is equipped with an acoustic indicator that emits a variety of sounds
when in use
The picture above shows the Armotion as a whole. The Armotion interacts with a PC using
dedicated software. Communication with the PC is done via Bluetooth.
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Armotion
Dedicated
PC
The patient will be required to perform therapeutic exercises according to his needs. While
performing the given exercise kinematic data (position, velocity and accelerations) and dynamic
data (the forces exerted by the patient) will be recorded.
Analysing these data, it will be possible to:
• Correct in real time the movements of the patient
• Evaluate the performance at the end of each therapy session
• Evaluate the progresses out of the overall therapies sessions
• Retrieve logged data for off-line analysis
The Armotion system can be used with three different handles, depending on the needs and
capabilities of the patient.
• 2 horizontal handles, i.e. parallel to the work surface
• 1 vertical handle, i.e. perpendicular to the work surface
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•
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To replace a handle just extract it from its seat - pull up perpendicular to the floor until you pass
the seals - and replace with the desired handle.
Possibly you can prevent rotation of the hand pieces with respect to support for the patient's
arm, where this is more convenient for the patient. In this case position the locking plate into its
seat, before inserting the handle again.
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switch
6 Operation of Armotion
6.1 Switching on the Armotion
The device is equipped with two emergency switches (red button mushroom shaped) on board.
When pressed these switches cut off power to the motors, blocking the motion of the device.
The emergency stops are mounted on the sides of the Armotion, and the user can stop the
motion of the device at any time.
Emergency stop Emergency stop
Connector for the
external emergency
A third emergency switch, external, can be inserted into the connector jack on the front of the
Armotion.
NOTICE
Although the system functions even without the switch external emergency, it is highly
recommended that this is connected to the Armotion.
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NOTICE
When connected, the external switch deactivates the possibility of using the two side
emergency stops.
6.2 Starting the Armotion
1. Make sure the Armotion is off
2. Make sure that one of the emergency shutdown system is pressed
3. Launch the software
4. Do not touch or load the handle and then turn on the Armotion through the main switch
5. Release the emergency switch (i.e. make sure they are all released)
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6. Wait for an active (green light) Bluetooth connection of the ARMOTION
NOTICE
If the PC fails to successfully establish the Bluetooth connection the device cannot be started.
Restart the procedure using the following order:
- Press the Emergency Button on the Armotion
- Make sure that the Armotion is still turned on (acoustic signal sound active)
- Close the Hydra Pronta Window by pressing the small x is the top right
- Turn off the Armotion Power Button
- Double Click the Armotion Icon on the right top of the desktop
- Do not touch the handle and then turn on the Armotion Power Button
If the problem persists, contact the Reha Technology AG.
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7 The Armotion Software
The Armotion provides a wide range of therapy variations which in general can be selected
independently and adapted to the patient’s needs.
NOTICE
A comprehensive training of the operator on the software by a staff member of Reha
Technology or a Certified Armotion Operator is mandatory.
NOTICE
Please familiarize yourself with the warnings of the ARMOTION Software before starting the
use of Armotion.
NOTICE
The Armotion is delivered with the software already installed.
Risk of injury to the patient
The Armotion and the ARMOTION software may only be started if the device is set up in a
stable position.
7.1 Starting the Software
Launch the application by double-clicking on the desktop icon of the Armotion software.
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Once started, the Armotion software opens the patient file.
You can create a new patient file or select a patient who is already stored in the database. Once
the patient file is selected or created, the therapy can start.
NOTICE
Patient’s specific information (personal data, and patient’s performance) are saved under the
patient’s file. The type, length, and the results of the individual therapy sessions are recorded
in order to be further analysed for data for research purposes or reimbursement. Therefore
please keep in mind data protection laws and regulations of your respective country
7.2 Navigation in ARMOTION Software
The overall software and its functions are distributed in tabs.
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Each tab is associated to a specific command, making it easy to navigate through the functions
that the software provides.
• Patient File: allows to manage the patient database and patient selection
• Exercises: allows to define the training mode
• Results: allows to view patient’s performance and statistics
• Calibration: allows to calibrate the force sensors of the device
• Help: provides access to the User Manual
7.3 Patient File
Through this section it is possible to manage the patient database, adding, removing or changing
patient data.
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Use the “patient search” button to search and select an existing patient file. Enter search values
such as name, surname or place of birth.
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Create a new patient by clicking on the button “new patient” and insert the patient information.
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7.4 Exercises
After having selected the patient click on “Exercises” and select the training mode:
• Tracks: it requires the patient to follow the given trajectories
• Coins: it requires the patient to grab the coins and bring them back to the centre of the
work plan
•Car racing: it requires the patient to chase the computer along one of the given
trajectories
• Memory: it requires the patient to make an association between two objects
• Dish Washing: it requires the patient to wash dishes in a sequence of predetermined
actions.
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• Make sure the working surface is horizontal (parallel to the ground) and well-fixed to
the supporting table.
7.4.1 Parameters common to all exercises
7.4.1.1 Auto mode: passive therapy option
Continuous passive movement.
Speed: choose from the options Slow, Normal or Fast to determine the speed of the armotion
when in auto mode.
7.4.1.2 Normal Mode: active assistive therapy option
Active-assistive mode compensates the difficulties of the patient by a self-initiation of the
movement. Active-assistive mode supports the patient to actively start the selected exercise.
Correction Force: select from the options Stiff, Medium or Soft to determine the force that will
be opposed to the patient when he moves away from the given trajectory.
Weight: select from the options Light, Medium or Heavy to simulate changes in the mass of the
Armotion.
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Viscosity: select from the options Sliding or Sticky to simulate the viscous friction along the
trajectory of the Armotion
NOTICE
When in Auto mode the Armotion leads the patient passively over the given trajectory.
When in auto mode the setting stiffness, weight and viscosity cannot be adjusted.Run the
Armotion in auto mode and show the patient how to do the exercise correctly.
7.4.2 Exercise “Tracks”
The patient should follow a given trajectory drawn from the track selected. No time limits are
set. If the patient moves too far away from the trajectory the robot will exert an increasing
resisting force to return it to the ideal trajectory.
In order to initiate the training mode the patient is required to reach the initial position on the
grid, without having to follow a particular path.
If the patient does not start or is motionless, the robot accompanies the patient to a portion of
the given trajectory. Auto mode feature.
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A counter shows the number of the remaining laps, the partial lap time being, the best lap time
among those made during the therapy session and the time elapsed since the beginning of the
training.
The exercise can be interrupted at any time by pressing “Esc”
The following trajectories can be selected:
• Eight
• Track
• Letter D
• Oval
The following settings can be adjusted according to the patient’s clinical condition and the
intended outcome of the therapy session:
Number of laps: select the number of laps to be made to complete the exercise
Size: set Small, Medium or Large depending on the range of motion and the anthropometric
dimensions of the patient (the given trajectory will result to be scaled in the work plan)
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Position: mirror the trajectories -letter D and track-, taking them from the right or to the left of
the patient. Even the trajectories - eight and oval - have variants side designed to facilitate their
execution with the right or left arm.
Direction: choose between the clockwise or counter clockwise options.
Once all the desired parameters are set press the Start button.
A session manager and pop up window will open.
The exercise with the selected parameters will start automatically: the patient is asked to
approach the starting position, and after a short countdown can begin to training session.
Once completed, the software shows the score and the energy expressed by the patient during
the session.
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7.4.3 Exercise “Coins”
In this exercise the patient is asked to collect the coins arranged on an arc of ellipse. For every
coin he will have to start from a central position, going over a coin, and return to the central
starting position.
If the patient fails to achieve the goal or crashes or is still too slow is therefore helped by the
Armotion. When on auto mode the exercise is passively driven by the Armotion.
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The following settings can be adjusted according to the patient’s clinical condition and the
intended outcome of the therapy session:
Number of repetitions: allows defining the number of rounds in order to complete the exercise
Size: set Small, Medium or Large depending on the range of motion and the anthropometric
dimensions of the patient (the given trajectory will result to be scaled in the work plan)
Once completed the exercise shows the score and calories burned
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7.4.4 Exercise “Car racing”
In this therapy mode the patient is required to chase the computer along one of the given
trajectories. The controls and the scoring is otherwise equivalent to the tracks exercise.
Select the desired track and start the exercise as previously described.
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7.4.5 Exercise “Memory”
In this therapy mode the patient is required to make an association between two objects
The exercise starts when the Armotion is brought to the centre of the work plan. At this point,
after a brief countdown, the patient can go to any of the icons and pausing for 1 second the
cursor circle pencil icon to indicate that it has been selected. Once an icon is selected the patient
is asked to select the corresponding icon.
In this exercise, the patient is completely free to move. The Armotion comes to the aid of the
patient after 25 seconds if no icon is selected. If an icon is already selected, but after 25 seconds
still missing the second to close the association, the Armotion intervenes accompanying the
patient to the associated icon.
The exercise can be interrupted at any time by pressing the “esc”
Choose between two, three or four associations (pairs) and set the following parameters:
Number of repetitions: allows defining the number of rounds in order to complete the exercise
Size: set Small, Medium or Large depending on the range of motion and the anthropometric
dimensions of the patient (the given trajectory will result to be scaled in the work plan)
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At the end of the therapy session, a scoring system is shown as previously described.
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7.4.6 Exercise “Dish Washing”
The “dish washing” therapy mode simulates the movement of the daily life of washing the dishes.
Click on the icon “dishes” and set the following:
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Number of repetitions: allows defining the number of rounds in order to complete the exercise
Side: select left or right arm
In this exercise, the patient is requested to accomplish the following tasks:
• Move the first dirty plate from the stack of plates on the right shelf to the sink- central
• Grasp the soapy
• Clean the plate with 3 complete movements (left to right/right to left)
• Leave the sponge on its support
• Open the tap water
• Close the tap water
• Grasp the drying mat
• Dry the plate with three complete movements (left to right/right to left)
• Leave the mat on its support
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7.4.7 Scoring and results
All exercise offer a score at the end of the game and detailed results are available directly after
the game has been finished or at a later point from the results overview.
Once completed, the software shows the score and the energy expressed by the patient during
the session.
The score is calculated taking into account the following parameters:
• degree of autonomy of the patient determined at the time of activity: (time spent with
active user in robot moving - time spent with active user in robot stopped) / (total exercise
duration - time spent stationary robot)
• degree of autonomy of the patient's calculated on the work done: work of the patient
along the trajectory / (patient work along the trajectory + working robot along the
trajectory)
• accuracy of the patient work along the trajectory / total work of the patient
• normalized speed: average speed of the patient / ( maximum possible speed x 80 % )
The measured value of the performance would be equal to the sum of the 4 above-mentioned
parameters each multiplied by a weight (currently the weights are all places to 1/4).
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Finally, the weighted sum is multiplied by a factor of 10 to obtain a score between 0 and 10.
• between 0 and 4, the test is considered NOT sufficient
• above 4 and up to 6, the test is considered to be sufficient
• over 6 evidence is considered successfully passed ( and the PC speaker will reproduce the
sound of applause )
Once the therapy ends a session manager window opens.
By pressing “start” it is possible to repeat the exercise with the same settings. Click on “esc+ to
return to the main menu.
By clicking on “results” the system shows the following:
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•Power Consumption: shows the distribution of energy consumed between patient and
robot
• Trajectory : shows the trajectory of the armotion while performing the exercise
• Forces : Shows the forces of interaction between patient and the armotion as recorded
during the exercise
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•Jobs: shows the work done by the patient and by the robot , in the direction tangent to
the path and in the perpendicular
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•Time alone: shows a box plot relative to the time when the user has been active (time not
spent in automode )
•Distance in autonomy: shows a box plot on the distance travelled by patient autonomy (
distance not travelled in auto mode )
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•Scores: multiplication table summarizing the numerical values of the results
o degree of autonomy of the patient calculated on time
o degree of autonomy of the patient calculated on the job
o accuracy of patient
o speed normalized
o user's work
o Work Robot
o total exercise duration
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8 Maintenance
The present chapter describes how to take care of the Armotion.
NOTICE
More detailed information for reparation purpose can be found in the Service Manual.
Risk of materialdamage or personal injurydue to improperrepairs and maintenance!
Improper maintenance can cause serious damage on the device or injury to the patient and
therapist.
• Repairs and maintenance, beside the procedures described in this manual, may only
be performed by staff of Reha Technology AG or personnel trained and authorized by
Reha Technology AG.
8.1 Cleaning the Armotion
If not requested, carry out the cleaning in regular intervals by a moistened cloth and hot water
or disinfectant. Clean the device and the working surface daily to ensure proper functioning.
NOTICE
Do not use phenol- or chlorine based cleaning agents, for they could harm leather, aluminium
and plastic.
Cleaning the Armotion:
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The Armotion consists of parts made aluminium, PVC and delrin covered by paint. To clean and
disinfect them (after every therapy session) please always use agents which are tolerated by the
finish (see notice above).
Cleaning the working surface:
For cleaning the working surface, use a dry or slightly moist cloth. If there are stubborn stains the
cloth can be moistened with alcohol. However do not use abrasive cleaners, detergents or
solvents. If there should be large stains which cannot be removed please contact Reha
Technology AG.
8.2 Annual Maintenance Check
A maintenance check has to be carried out by Reha Technology or authorized technicians only,
at least once a year.
Yearly repeated checks have to be carried out in accordance with EN 60601-1:2007
Risk of material damage and/or injury by not executed maintenance!
The Armotion can only be used if all the required maintenance actions have been executed
by Reha Technology AG or third parties authorized by Reha Technology AG.
9 Disposal
The Armotion may not be disposed but has to be returned to Reha Technology AG.
NOTICE
The user has to be informed on effective local, regional or national waste disposal regulations.
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Reha Technology AG
Industriestrasse 78
4600 Olten
SWITZERLAND
E-Mail: info@rehatechnology.com
Internet: www.rehatechnology.com
Published December, 2014
Original language: English
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