Reha Technology RTAM1000 Armotion Robotic Device for Neuro-Rehabilitation User Manual

Reha Technology AG Armotion Robotic Device for Neuro-Rehabilitation

User Manual

    Armotion™      User Manual
1 Introduction ................................................................................... 1 1.1 About the User Manual ............................................................................................... 1 1.2 Explanation of Symbols ............................................................................................... 2 1.3 Warranty and Liability ................................................................................................. 3 1.4 Copyright Protection ................................................................................................... 4 2 The Armotion™ ............................................................................... 5 2.1 General ........................................................................................................................ 5 2.2 Manufacturing and Optimization ................................................................................ 6 2.3 Type Label ................................................................................................................... 6 3 Safety Instructions .......................................................................... 7 3.1 Intended Use ............................................................................................................... 7 3.2 Contraindications ........................................................................................................ 8 3.2.1 General contraindications .................................................................................... 8 3.2.2 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 7.3 Patient File ................................................................................................................. 25 7.4 Exercises .................................................................................................................... 28 7.4.1 Parameters common to all exercises ................................................................. 29 7.4.1.1 Auto mode: passive therapy option ........................................................... 29
7.4.1.2 Normal Mode: active assistive therapy option .......................................... 29 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
User Manual - Version 1.7  Armotion™  Page 1 of 49 1 Introduction 1.1 About the User Manual The  manual  contains  all  the  information  necessary  in  order  to  ensure  the  safe  use  of  the Armotion. This manual is intended for the use of the software version 1.2 and its subversions. In case there are software updates performed new user manuals are distributed if required. The manual is intended for medical and therapeutic personnel. Practical knowledge of medical processes and applications as well as the technical terms used for the execution of this type of therapy are a prerequisite to operating personnel. Trained and qualified medical personnel and therapists who are responsible 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 is integral part of the device and has to be kept near the related device, ensuring access to operating personnel at all times. This user manual can also be accessed directly on the PC via a link in the program. All images, pictures, diagrams, screenshots and drawings are figurative and can differ from the effective appearance. In addition to the hints provided by this manual, local accident prevention regulation, national health and safety measures have to be taken into account.
User Manual - Version 1.7  Armotion™  Page 2 of 49 1.2 Explanation of Symbols The symbols and signal words are used in order to point to hazards that can cause accidents, injuries or property damage. The instructions must be observed in order to ensure the safe use of the Armotion.     This combination of symbol and signal word points to an imminent danger that may lead 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 warns of a potentially dangerous situation that could lead to material losses and environmental damage and / or gives important additional information to be aware of.
User Manual - Version 1.7  Armotion™  Page 3 of 49 1.3 Warranty and Liability The warranty and liability of Reha Technology AG are based on the purchase contract.  NOTICE The warranty and liability shall expire prematurely if the customer or a third party: • uses and commands the Armotion not according to this manual, • does not apply the national health and safety regulations, • applies inappropriate changes or repairs to the device, • allows changes, repairs or maintenance by physical or legal persons not certified by the manufacturer of the device, • 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 cleaning instructions given by this manual.  NOTICE The connection of devices not recommended in this manual is not permitted and must always be agreed with Reha Technology AG.   Liability and warranty loss or voidance to operate the the equipment through unauthorized modifications! • All unauthorized technical modification is prohibited.
User Manual - Version 1.7  Armotion™  Page 4 of 49  Changes or modifications to this unit not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.  Defects  which  cannot  be  traced  directly  to  Reha  Technology  by  means  of  improper  material quality, faulty construction or assembly as well as defects caused by factors outside the control of Reha Technology are excluded from warranty and liability regulations. Liability  of  subsequent error is excluded 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  manual  including  all  figures  and  drawings  are  copyrighted information and property of Reha Technology and are exclusively provided for the purpose of operation, maintenance and repair. Dissemination for other purposes or copying thereof without previous written consent by Reha Technology is forbidden.
User Manual - Version 1.7  Armotion™  Page 5 of 49 2 The Armotion™ 2.1 General The  Armotion  is  an  innovative  robotic  solution  in  the  treatment  of  severe  and  moderate neurological and orthopaedic dysfunction of the upper extremity.  The Armotion`s unique force feedback and force multiplier features detect and react on patient movements, maximizing the effect of each therapy session. The combined recording of kinematic (speed and direction) and dynamic (force interaction by the patient) parameters allow a precise quantitative  evaluation  and  constant  monitoring  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 batteries and the short and simple setup and quick start of therapy further contribute to an optimized allocation of the hospitals resources on a daily routine. The Armotion can easily be employed both in the treatment of severe and moderate neurological dysfunctions (i.e. post stroke recovery) as well as in the rehabilitation of orthopaedic conditions.
User Manual - Version 1.7  Armotion™  Page 6 of 49 Patients exhibiting deficits in the range of motion and strength of the shoulder and elbow with or without minor cognitive deficits related to recognition, find the use of Armotion an innovative solution for a prompt functional recovery. 2.2 Manufacturing and Optimization The  Armotion  was  designed  and  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 your inputs by contacting: info@rehatechnology.com 2.3 Type Label At the bottom of the Armotion there is a label containing the following information
User Manual - Version 1.7  Armotion™  Page 7 of 49  3 Safety Instructions This  chapter  provides  an  overview  of  all  important  safety  aspects  for  the  safe  and  proper operation of the Armotion. 3.1 Intended Use Only when used according to the specifications of the user manual, the operating safety can be guaranteed. The Armotion is intended only for use on patients with severe and moderate motor disorder  of  the upper  extremities  –  shoulder  and  elbow.  Dedicated  software,  with  numerous exercises, allows the therapist to choose the ideal protocol according to the patient’s dysfunction and therapeutic goal. The software records and evaluates each exercise done by the patient 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  effectiveness    in  the  treatment  of patients with damage to the central nervous system (i.e. post stroke recovery) and in patients with neurodegenerative syndromes and polyneuropathies. . . As mentioned it may be particularly useful for those patients with serious motor limitations that therefore could not be treated with conventional occupational therapy. The Armotion is a medical device according to CE class 2a and therefore it shall be used with a prescribed physical therapy.
User Manual - Version 1.7  Armotion™  Page 8 of 49 Given  the  mentioned  application  areas  of  use, the  practitioner  defines  the  intended  use  and mode of administration of therapy depending on the severity of the disease and diagnosis.    The system may not be operated by non-qualified personnel! Accidents and injuries due to ignorance and misuse • Read the user manual   NOTICE Any additional and / or different use of the Armotion is prohibited and is considered to be improper.  3.2 Contraindications  As it is the case with any other therapy, 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 wounds or pressure points and for ones which may have been caused by the therapy. • Cooperation: whether or not a therapy on the Armotion can be carried out on patients with reduced cooperation, psychotic illnesses or neurotic dysfunctions has to be carefully considered in each individual case. • Spasticity: Modified Ashworth Scale >3*
User Manual - Version 1.7  Armotion™  Page 9 of 49  Please  note  that  other  contraindications  which  are  not  listed  here  may  be  present  in  your patients. If anything is unclear, or if you have feedback please contact Reha Technology AG. (See contact details on the last page). 3.2.2 Spasticity management  Clinical studies confirms that active movement training does not result in increased hypertonia, but results in spasticity reduction in antagonist muscles by activating the reciprocal inhibition mechanism.  Furthermore  robot  –mediated  therapy  contributes  to  a  decrease  in  motor impairment of the upper limbs in subjects with chronic hemiparesis, resulting in a reduction on shoulder pain.** Clinical  observation  show  how  Armotion  can  accommodate  neuromuscular  abnormalities associated with spastic joint evaluated on a Modified Ashworth Scale Bohannon & Smith value:  < or = 3.  As a general indication we recommend either both manual gentle muscle stretching techniques (i.e conventional muscle stretching, 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 increase in tone giving a catch when the limb was moved in flexion or extension Slight increase in muscle tone, manifested by a catch and release or by minimal resistance at the end of the range of motion when the affected part(s) is moved in flexion or extension 1+ (2)  Slight increase in muscle tone, manifested by a catch, followed by minimal resistance throughout the reminder (less than half) of the ROM (range of movement) 2 (3)* More  marked  increase  in  tone  but limb easily flexed More marked increase in muscle tone through most of the ROM, but affected part(s) easily moved 3 (4) Considerable  increase  in  tone  - passive movement difficult Considerable  increase  in  muscle  tone  passive,  movement difficult 4 (5) Limb rigid in flexion or extension Affected part(s) rigid in flexion or extension
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)
User Manual - Version 1.7  Armotion™  Page 11 of 49 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 The Armotion may only be under the supervision of a medical specialist.
User Manual - Version 1.7  Armotion™  Page 12 of 49    Explosion hazard 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.
User Manual - Version 1.7  Armotion™  Page 13 of 49 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
User Manual - Version 1.7  Armotion™  Page 14 of 49 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.   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 stop  Exchangeable battery Counterweight
User Manual - Version 1.7  Armotion™  Page 15 of 49     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.
User Manual - Version 1.7  Armotion™  Page 16 of 49   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  Armotion Dedicated PC
User Manual - Version 1.7  Armotion™  Page 17 of 49 •
User Manual - Version 1.7  Armotion™  Page 18 of 49
User Manual - Version 1.7  Armotion™  Page 19 of 49  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.
User Manual - Version 1.7  Armotion™  Page 20 of 49 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.     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 the external emergency switch Emergency stop Emergency stop
User Manual - Version 1.7  Armotion™  Page 21 of 49  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)
User Manual - Version 1.7  Armotion™  Page 22 of 49 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.
User Manual - Version 1.7  Armotion™  Page 23 of 49 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.
User Manual - Version 1.7  Armotion™  Page 24 of 49  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.
User Manual - Version 1.7  Armotion™  Page 25 of 49 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.
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.
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.
User Manual - Version 1.7  Armotion™  Page 28 of 49 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.
User Manual - Version 1.7  Armotion™  Page 29 of 49  • 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.
User Manual - Version 1.7  Armotion™  Page 30 of 49 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.
User Manual - Version 1.7  Armotion™  Page 31 of 49  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)
User Manual - Version 1.7  Armotion™  Page 32 of 49 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.
User Manual - Version 1.7  Armotion™  Page 33 of 49
User Manual - Version 1.7  Armotion™  Page 34 of 49 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.
User Manual - Version 1.7  Armotion™  Page 35 of 49  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
User Manual - Version 1.7  Armotion™  Page 36 of 49   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.
User Manual - Version 1.7  Armotion™  Page 37 of 49 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)
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.
User Manual - 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:
User Manual - Version 1.7  Armotion™  Page 40 of 49  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
User Manual - Version 1.7  Armotion™  Page 41 of 49 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).
User Manual - Version 1.7  Armotion™  Page 42 of 49 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:
User Manual - Version 1.7  Armotion™  Page 43 of 49 • 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
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
User Manual - Version 1.7  Armotion™  Page 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 )
User Manual - Version 1.7  Armotion™  Page 46 of 49 • 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
User Manual - Version 1.7  Armotion™  Page 47 of 49 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 material damage or personal injury due to improper repairs 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:
User Manual - Version 1.7  Armotion™  Page 48 of 49 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.
User Manual - 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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