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Reha Technology Armotion, User Manual

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Reha Technology Armotion User Manual Download Page 13

User Manual - Version 1.7 

Armotion™ 

 

Page 

10

 of 

49 

**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) 

Summary of Contents for Armotion

Page 1: ...Armotion User Manual ...

Page 2: ...2 Spasticity management 9 3 3 General Hazards 10 3 4 Personnel Qualification 10 4 Specifications 11 4 1 Specifications in Detail 11 4 2 Operating Conditions 11 4 3 FCC compliance 12 5 Components 13 5 1 Overview 13 6 Operation of Armotion 20 6 1 Switching on the Armotion 20 6 2 Starting the Armotion 21 7 The Armotion Software 23 7 1 Starting the Software 23 7 2 Navigation in ARMOTION Software 24 7 ...

Page 3: ... 7 4 2 Exercise Tracks 30 7 4 3 Exercise Coins 34 7 4 4 Exercise Car racing 36 7 4 5 Exercise Memory 37 7 4 6 Exercise Dish Washing 39 7 4 7 Scoring and results 41 8 Maintenance 47 8 1 Cleaning the Armotion 47 8 2 Annual Maintenance Check 48 9 Disposal 48 ...

Page 4: ...for the Armotion are obliged to ensure that technicians patients and other persons who are present around the device comply strictly with the safety regulations contained within this document This manual describes the operation and maintenance of the Armotion Compliance with the stated safety and operating instructions is a prerequisite for safe and proper operation of this machine The user manual...

Page 5: ...d to death or serious injury if not avoided This combination of symbol and signal word indicates a potentially hazardous situation which could result in death or serious injury if not avoided This combination of symbol and signal word indicates a potentially hazardous situation which could result in moderate or minor injury if it is not avoided NOTICE This combination of symbol and signal word war...

Page 6: ...evice impedes the installation and commissioning of the device by physical or legal persons certified by the manufacturer of the device or the manufacturer itself does not contact Reha Technology AG to provide assistance and repairs in case of defect and or does not take actions to minimize damage uses non original or not by Reha Technology approved spare parts does not comply with maintenance and...

Page 7: ...xcluded if not in direct conflict with national product liability regulations This is valid also for defects which can provoke inherited damage to the device known by the manufacturer Reha Technology reserves the right to implement technical modifications on the product in order to improve the usage requirements and device characteristics 1 4 Copyright Protection The contents of this instruction m...

Page 8: ...g of patient progress The patient s cognitive ability is enhanced by multiple functional ADL related game types and a unique active assistive therapy option The substantial reduction in size its portable and compact design and state of the art technology makes the Armotion an easy to use device for the rehabilitation of the upper extremities The wireless connection to the computer the rechargeable...

Page 9: ...developed by Humanware S r l and Reha Technology AG in cooperation with the medical University of Pisa Italy Reha Technology AG is interested in continual optimization of the practical use of the therapy on patients and improvements to ease of operation of its devices For this process Reha Technology AG is dependent on you as a regular user for ideas and suggestions Please do not hesitate to share...

Page 10: ...nt The fields of application include Neurological Rehabilitation Post traumatic rehabilitation Orthopaedic and after surgery rehabilitation The Armotion also finds applications in those patients without force and or without anti gravity abilities i e patients who are unable to lift the arm shoulder The use of the Armotion in the rehabilitation of the upper extremities has shown clinical effectiven...

Page 11: ...the treating physician is responsible for compliance with the indications 3 2 1 General contraindications Unstable fractures of the upper extremity do not carry out any therapy on patients with unstable fractures or fractures which have not yet suitably consolidated Heavy Osteoporosis there might be a danger of fractures Skin problems Before and after each therapy make a visual check for existing ...

Page 12: ...tching muscle reinforcement physical agent and pain management techniques prior to the training on Armotion 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 Score Ashworth Scale 1964 Modified Ashworth Scale Bohannon Smith 1987 0 0 No increase in tone No increase in muscle tone 1 1 Slight inc...

Page 13: ...t 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 Medicin...

Page 14: ...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 dr...

Page 15: ...t 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 interfer...

Page 16: ...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 ...

Page 17: ...f the Armotion 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 Arm support Emergency stop Connector for external safety switch Main Switch On off Exchangeble handle Emergency sto...

Page 18: ...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 ...

Page 19: ... 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 ...

Page 20: ...User Manual Version 1 7 Armotion Page 17 of 49 ...

Page 21: ...User Manual Version 1 7 Armotion Page 18 of 49 ...

Page 22: ...icular 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 ...

Page 23: ...otion 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 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 Connector for...

Page 24: ...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 ...

Page 25: ...ure 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 ...

Page 26: ...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 Armotionis 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 So...

Page 27: ...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 Softwa...

Page 28: ...s 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 ...

Page 29: ...User Manual Version 1 7 Armotion Page 26 of 49 Use the patient search button to search and select an existing patient file Enter search values such as name surname or place of birth ...

Page 30: ...User Manual Version 1 7 Armotion Page 27 of 49 Create a new patient by clicking on the button new patient and insert the patient information ...

Page 31: ...ow 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 ...

Page 32: ...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...

Page 33: ...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 t...

Page 34: ...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 dimension...

Page 35: ... 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...

Page 36: ...User Manual Version 1 7 Armotion Page 33 of 49 ...

Page 37: ...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 ...

Page 38: ...e 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 ...

Page 39: ... 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 ...

Page 40: ...atient 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 associatio...

Page 41: ...User Manual Version 1 7 Armotion Page 38 of 49 At the end of the therapy session a scoring system is shown as previously described ...

Page 42: ...anual Version 1 7 Armotion Page 39 of 49 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 ...

Page 43: ...sted 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...

Page 44: ...d 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 wor...

Page 45: ...t 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 ...

Page 46: ...sumption 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 ...

Page 47: ...User Manual Version 1 7 Armotion Page 44 of 49 Jobs shows the work done by the patient and by the robot in the direction tangent to the path and in the perpendicular ...

Page 48: ...ge 45 of 49 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 ...

Page 49: ...tion 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 ...

Page 50: ...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 dai...

Page 51: ...e 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 req...

Page 52: ...l Version 1 7 Armotion Page 49 of 49 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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