adamo ROBOT User Manual

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EDITED BY:

TECHNICAL RESPONSIBLE

SNA

Date: 03/10/2024

Signature:

Dssdfsa

ADAMO ROBOT - V 1.0

User manual

REVISED BY:

QUALITY MANAGER

RESPONSIBLE FOR REGULATORY

SNA

Date: 03/10/2024

Signature:

COMPLIANCE

SNA

Date: 03/10/2024

Signature:

APPROVED BY:

MANAGING DIRECTOR

CGI

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Summary of Contents for adamo ROBOT

Page 1 EDITED BY: REVISED BY: APPROVED BY: TECHNICAL RESPONSIBLE QUALITY MANAGER MANAGING DIRECTOR RESPONSIBLE FOR REGULATORY COMPLIANCE Date: 03/10/2024 Date: 03/10/2024 Date: 03/10/2024 Date: 03/10/2024 Signature: Signature: Signature: Signature: Dssdfsa ADAMO ROBOT - V 1.0 User manual...
Page 2: Table Of Contents
PRINCIPLES OF OPERATION OF THE DEVICE AND MODE OF ACTIONS ........17 Pressure and massage ......................17 Thermotherapy ........................18 Air compression and its effects .................... 18 Mode of action ........................19 List of configurations ......................20 USE INSTRUCTIONS ........................24 Informatic system ....................... 24 Robot power-up ........................24...
Page 3 TD Code: ADM-001 Version: 03 USER MANUAL Date:03/10/2024 Page 3 de 69 Manual modification of the temperature ................25 User interface ........................26 Configuration Screen ......................30 Patients Screen ........................31 Treatments Screen ......................36 SAFETY FEATURES ........................58 Types of security ......................... 58 On screen messages ......................
Page 4: General Description Of The Product
ADAMO Robot ensures seamless human-robot collaboration, providing security and flexibility in its use. Equipped with the collaborative robotic arm UR5e from Universal Robot, this device offers a unique combination of precision, ease of use, and adaptability. The standard treatment offered by ADAMO Robot consists of personalized sessions during which continuous pressure is applied using compressed air on myofascial trigger points defined by qualified medical professionals.
Page 5: Declaration And Class Iia Medical Device
Length = 104 mm - Height = 180 mm - Width = 1 mm It is applied externally on one side of the machine and expresses the following data, legibly: • ADAMO ROBOT LOGO, UDI-DI, WARNING SYMBOLS • CE MARKING, NAME AND ADRESS OF THE MANUFACTURER •...
Page 6: Symbols
TD Code: ADM-001 Version: 03 USER MANUAL Date:03/10/2024 Page 6 de 69 Symbols SYMBOL TITLE STANDARD CE Mark – Notified Body 0297 MDR 2017/745 Medical device Unique device identifier Serial number ISO 7000-2498 Manufacturer ISO 7000-3082 Refer to instruction manual/booklet ISO 7010-M002 Generic warning ISO 7010:2003-W001...
Page 7: State "Machine Off
TD Code: ADM-001 Version: 03 USER MANUAL Date:03/10/2024 Page 7 de 69 Before using the machine, authorized operators are required to undergo clinical and technical training and pass usability tests. It is necessary for users to receive appropriate clinical and technical training and to pass the corresponding usability tests before using the machine.
Page 8: Indications, Contraindications And Warnings
(e.g., office-related muscle pain, sports overuse injuries). ▪ Age and ability to cooperate: ADAMO ROBOT® is primarily indicated for adults between 18 and 60 years of age who can cooperate during treatment and remain in the appropriate position throughout the session.
Page 9: Contraindications
▪ Fever and systemic infections: Patients with fever or systemic infections should not undergo treatments with Adamo Robot, as the application of pressure or heat could exacerbate the underlying condition. ▪ Severe circulatory disorders: Treatment is contraindicated in patients with severe vascular diseases such as deep vein thrombosis or chronic venous insufficiency, where pressure could increase the risk of complications.
Page 10: Warnings
For a thorough understanding of device functionality, the user shall read the instructions for use in its entirety before starting to use the device. ▪ Before using the equipment, users are required to be trained. Do not use ADAMO ROBOT® if you are not trained for it. ▪...
Page 11 ADAMO ROBOT S.L. ▪ Each user has a user name and password to access to ADAMO ROBOT®. User name and password ensure privacy and confidentiality of patient data. Do not share with other persons.
Page 12: Technical Description
Page 12 de 69 TECHNICAL DESCRIPTION All the specifications shown in this section corresponds to the ADAMO ROBOT V1.0: Name of parts The medical device ADAMO ROBOT® is composed of the key functional elements laid down. ADAMO ROBOT® key functional components Code Element...
Page 13 Main power switch Green illuminated green power switch Arcoelectric Label Inox sheet CE Label Graincas ADAMO ROBOT® list of key functional components On the other hand, inside the end-effector there are the following main components: ADAMO ROBOT® end-effector Code Element Description...
Page 14: Dimensions Of The Machine
The following figure shows the clearances of the machine and for the movements of the robotic arm. Al dimensions are given in mm. Top View Side View Illustration 2. Top view and side view of ADAMO robot Technical data ADAMO ROBOT V1.0 Power Supply (VAC / Hz)
Page 15: Intended Use Of The Machine
.” YOU MUST KEEP THE MACHINE OUT OF REACH OF UNAUTHORIZED PERSONS. ADAMO ROBOT® is intended to support users in alleviating musculoskeletal pain INTENDED PURPOSE and enhancing movement and daily function in patients, through physiological effects on muscle tension and neural signalling.
Page 16: Device Configuration
TD Code: ADM-001 Version: 03 USER MANUAL Date:03/10/2024 Page 16 de 69 DEVICE CONFIGURATION To ensure optimal performance and proper integration with our system, it is essential to perform the correct configuration of the device. Below are the necessary steps to set up our equipment: •...
Page 17: Principles Of Operation Of The Device And Mode Of Actions
These techniques are essential in physiotherapy to improve recovery processes and reduce pain in patients with musculoskeletal disorders. Below is a brief justification and review of the state of the art in order to support Adamo Robot's main therapeutic tools: pressure and temperature using compressed air.
Page 18: Thermotherapy
TD Code: ADM-001 Version: 03 USER MANUAL Date:03/10/2024 Page 18 de 69 Thermotherapy The use of temperature to generate physiological responses is one of the oldest tools in conservative treatment. In physiotherapy, temperature is a fundamental physical tool, which in many cases becomes the only treatment, or an essential adjuvant treatment.
Page 19: Mode Of Action
ADAMO ROBOT® is a device with a six-degree robotic arm able to place the air nozzle at its end-tool. The reach of the robot has been defined to treat at least half of a patient’s body high. This means that if the mean high of a patient is 1.75m the minimum reach of the robot must be 0.85m which may also...
Page 20: List Of Configurations
This model operates by executing a single cycle along the preconfigured points, with adjustments available for the speed, temperature, and treatment application time at each point. Upon starting the treatment, the robot moves to the safety position with respect to the first treatment point, and the air...
Page 21 If multiple cycles have been defined, the robot will return to the safe position with respect to the first point and repeat the entire process. Conversely, if only one cycle has been defined, the robot will...
Page 22 In this context, referred to as "pendulum," after applying the treatment at the last point, the robot returns directly to this point, then to the penultimate, and so on until reaching the first.
Page 23 Rest Time (10 min) Temperature (20 - 28ºC) 1. Point by point mode 2. On arch mode Treatment Time (0 to 25 min) Programmable 3. Lineal Rest Time (10 min) 4. Pendular Number of points (1 to 6) Fig, 20: ADAMO ROBOT® configurations...
Page 24: Use Instructions
This allows healthcare professionals to access information remotely from any device to track treatments. The Panel PC on the robot is supported by a support arm to move the PC panel screen so that the user can adjust the screen position while configuring treatments for patients.
Page 25: Manual Modification Of The Temperature
4. Confirmation of startup: You'll know that the robot has powered on successfully when the pup up indicating the “releasing of the breaks” will disappear.
Page 26: User Interface
The user interface runs in the cloud, and users access it through the Firefox web browser. Below, we will detail this interface so that physiotherapists can operate the robot, attending to all its different needs throughout the process while maintaining a focus as simple as possible to facilitate the operation of the Adamo robot.
Page 27 USER MANUAL Date:03/10/2024 Page 27 de 69 SerieId 01.1023.0001 Phone +34 91 417 04 57 ADAMO Robot S.L C/ Manuel Tovar, nº 49 28034 Madrid, Spain v1.0 email support@adamorobot.com Illustration 7. ADAMO robot: user interface (I) Company information Within this screen, the 'Company Information' button is displayed. By pressing this button, the following information regarding ADAMO appears for contacting in case it's necessary: •...
Page 28 USER MANUAL Date:03/10/2024 Page 28 de 69 Illustration 8. ADAMO robot: user interface (II) Help chat Another relevant button on this main screen is the help button, which has been integrated to provide you with the best real-time support and assistance. With just one click on the chat icon, located in the bottom right corner of the screen, you can connect directly with our support team.
Page 29 Date:03/10/2024 Page 29 de 69 User area Illustration 9. ADAMO robot: user interface (III) Dropdown button containing the following functionalities: Configuration: Selecting the configuration button opens the Configuration Screen where user information can be set up. This section will be explained in detail in the Configuration Screen section.
Page 30: Configuration Screen
The rest of the information regarding this area will be explained in the Patients Screen section. Touchscreen usage The built-in screens on the 'Adamo Robot' stations are touchscreen-enabled to facilitate interface usage, freeing the user from the need for a keyboard and mouse.
Page 31: Patients Screen
When clicking on the pencil icon, all the fields can be modified as shown below. It is important to note that these parameters must be filled in. Illustration 12. ADAMO robot: user interface (VI) Patients Screen In this screen, the user can see, create, search, edit and delete patients.
Page 32 USER MANUAL Date:03/10/2024 Page 32 de 69 Illustration 14. ADAMO robot: user interface (VIII) Create patients 1. Click on the button 2. In the “Create new patient” dialog box, fill in the information. There is a total of three Windows, to navigate through them, click the Continue button.
Page 33 TD Code: ADM-001 Version: 03 USER MANUAL Date:03/10/2024 Page 33 de 69 Illustration 15. ADAMO robot: user interface (IX) Illustration 16. ADAMO robot: user interface (X)
Page 34 Date:03/10/2024 Page 34 de 69 Illustration 17. ADAMO robot: user interface (XI) Once the windows are filled out and the Create button is pressed, the screen automatically returns to the Patients Screen, and the following message appears on the screen:...
Page 35 Screen. On this screen, you can view information related to a patient. This section will be explained in the following section. Edit patients When you click the Edit button, a screen opens to edit the patient's information. Once modified, click the Save Changes button. Illustration 19. ADAMO robot: user interface (XIII)
Page 36: Treatments Screen
To delete patients, you need to click on the Delete button. This opens the following window where you can choose to confirm deleting the patient or cancel the action. Illustration 20. ADAMO robot: user interface (XIV) Treatments Screen When clicking on a specific patient (or after creating a new one), you are redirected to the Treatments Screen. This screen features two sections: the Treatments section and the Information section.
Page 37 USER MANUAL Date:03/10/2024 Page 37 de 69 Information Where you can find the information entered during patient creation. Illustration 22. ADAMO robot: user interface (XVI) In this case, the user can click on the pencil icon to edit the patient information:...
Page 38 When creating a treatment and configuring it, it's important to consider the types of treatments that can be used and the effects of temperature on the treatment. After explaining the possible modes in which the robot can administer the treatment and under what circumstances it's better to use heat therapy and when to use cold therapy,...
Page 39 New treatment, View history, Edit, Delete, Start session, or Apply a session from an already created treatment. Illustration 25. ADAMO robot: user interface (XIX) New treatment To create a new treatment, the following steps must be followed: 1.
Page 40 This includes whether they have had previous injuries like the current condition (selectable through the Yes/No button), indicating if they have had an injury and its cause, and any possible observations. Illustration 27. ADAMO robot: user interface (XXI) 2.1.2. Click in Continue and the following screen will appear:...
Page 41 On this screen, you will need to enter the treatment area in the "Treatment" field (as indicated by the * next to "Treatment," it is mandatory information to save the treatment). You also need to specify the number of sessions for this treatment and click the "Start Capture" button for the robot to capture temperature and 3D images.
Page 42 2.1.4. Click the "Save" button to save both images and return to the previous window. 2.1.5. Once on this screen, after taking the photos, click the "Save" button. Illustration 31. ADAMO robot: user interface (XXV) 2.1.6. The user is redirected to another screen where you can see the information about the treatment to be applied, the temperature at which the treatment will be applied.
Page 43 Before pressing the Start Treatment button, it's important for the user to move the robot to the desired position for air application. To unlock the robotic arm, the user must press and hold the handle button for a few seconds, then, without releasing it, move it to the desired point, and finally release Illustration 33.
Page 44 TD Code: ADM-001 Version: 03 USER MANUAL Date:03/10/2024 Page 44 de 69 Illustration 34. ADAMO robot: user interface (XXVIII) 2.2.2. After clicking Continue, the next screen Will appear: Illustration 35. ADAMO robot: user interface (XXIX)
Page 45 Treatment* has an asterisk, it indicates that it is mandatory information to save the treatment). You also need to indicate the number of sessions for this treatment and the type of movement to be applied. After making these configurations, click the Start Capture button for the robot to take temperature and 3D images.
Page 46 The point indicator turns green, and the next one (in red colour) is activated. Illustration 39. The change in colour of the handle button of the robot in order to fix the necessary points.
Page 47 Version: 03 USER MANUAL Date:03/10/2024 Page 47 de 69 Illustration 40. ADAMO robot: user interface (XXXIII) Once all the required points have been saved, click the Finish button. 2.2.6. In accordance with the type of movement established, different variables will appear in the treatment configuration window for modification.
Page 48 Page 48 de 69 In this mode, we can change the air application time at each point, the speed at which the robot moves to reach the point, and the temperature at which the air is applied at that point.
Page 49 2.2.6.3. For the case of on arch: Illustration 43. ADAMO robot: user interface (XXXVI) In this case, besides modifying the temperature and the speed at which the robot moves, we also define the number of loops we want the movement to repeat.
Page 50 2.2.7. Once these parameters of the Treatment Configuration are defined, a window opens to start the treatment: Illustration 45. ADAMO robot: user interface (XXXVIII) 2.2.8. The user will be redirected to another screen where you can view the information about the treatment that will be applied, including the treatment temperature, type, the images that have been captured, and the current session.
Page 51 2.2.9. The user will be redirected to another tab where you will see the Start Treatment button to begin air expulsion, a timer to control the application time, a temperature indicator for the air application, and a progress section to track how the robot is moving through the points during the treatment. Illustration 47. ADAMO robot: user interface (XXXX) 2.2.10.
Page 52 TD Code: ADM-001 Version: 03 USER MANUAL Date:03/10/2024 Page 52 de 69 View history When clicking on View History, it redirects us to a tab, the History Tab, where all the information related to that specific treatment can be seen. In case there are more than one session for the same treatment, the photos taken and the information regarding the duration, temperature, and specific pressure for each of the sessions conducted can be seen.
Page 53 USER MANUAL Date:03/10/2024 Page 53 de 69 Illustration 48. ADAMO robot: user interface (XXXXI) Edit If the user clicks on the Edit button, it will redirect you to the Patient Information window, where you can modify any data on that screen. When you click Continue, it moves to the Treatment Configuration screen, where only the name...
Page 54 Date:03/10/2024 Page 54 de 69 Illustration 49. ADAMO robot: user interface (XXXXII) In the following treatment configuration screen, you can modify the temperature, time, and speed. We can see that we have gone directly from configuring the name to configuring the characteristics of the points. The coordinates of...
Page 55 USER MANUAL Date:03/10/2024 Page 55 de 69 Illustration 50. ADAMO robot: user interface (XXXXIII) Once this process is completed, click on Save, and the panel will redirect back to the Treatment Screen Delete When clicking on the Delete button, the following window opens to confirm or cancel the action of deleting a...
Page 56 USER MANUAL Date:03/10/2024 Page 56 de 69 Illustration 51. ADAMO robot: user interface (XXXXIV) Start Session If a treatment has been created with the option to perform multiple sessions, there is the option to start a predefined session. In this case, you need to click on the treatment you want to repeat, and the Start Session button will become active to be clicked.
Page 57 TD Code: ADM-001 Version: 03 USER MANUAL Date:03/10/2024 Page 57 de 69 Illustration 52. ADAMO robot: user interface (XXXXV) Then, click on Continue to be redirected to the treatment start screen. Illustration 53. ADAMO robot: user interface (XXXXVI)
Page 58: Safety Features
• Path of the robot during treatment: Think of its programming like a human arm. It won't work well if it's too extended or too close to the body. •...
Page 59: On Screen Messages
Security error Collision When the robot detects that the end-effector (2) of the robot is closer to patient that the appropriate treatment distance the robot will stop and show the following message in the screen. Ilustración 55. Screen messages (I) Click accept to continue.
Page 60 Robot in fail (rearm needed) Ilustración 57. Screen message (III) The different assumptions in which the robot will adopt the security position (home position) are explained below: If during a treatment session the patient or the staff touch the robot If during the "Teaching"...
Page 61 Version: 03 USER MANUAL Date:03/10/2024 Page 61 de 69 1. The robot stops in its current position. 2. A warning message appears on the screen. 3. Press the Rearm button in the screen. 4. The robot returns to the home position.
Page 62 PC panel and the PLC. This issue may arise due to a malfunction or disruption in the communication link between the control panel and the programmable logic controller (PLC) responsible for coordinating the robot's operations. Ilustración 60. Screen message (VI)
Page 63 Violation error There is also a critical error message indicating a violation in the robot's controller due to a misalignment or improper positioning of the robot. This error arises when the robot's movements deviate from the designated path or when it encounters an obstacle, causing a breach in its operational parameters.
Page 64: List Of Known Errors
• Issue: When starting the operating system, a black screen with the Ubuntu logo appears at the bottom Solution: Wait a couple of minutes until the main ADAMO startup screen appears. • Issue: When booting the device, a purple screen appears prompting for a startup password Solution: Enter the password "adamo"...
Page 65 When the physiotherapist makes a sudden or rapid movement with the manipulator during the point recording phase, the robotic arm will be locked for safety, and a message to rearm the robot will appear. Solution: Rearm the robotic arm from the PC screen. After the tab disappears, a second window will appear with a security message informing us of a problem.
Page 66: Warnings
ADAMO ROBOT S.L. • Ensure that the rear wheel brakes are locked before turning on the robot. This is a required safety check. • Protective gloves are mandatory to guard against burn risks.
Page 67: Preventive Maintenance
TD Code: ADM-001 Version: 03 USER MANUAL Date:03/10/2024 Page 67 de 69 PREVENTIVE MAINTENANCE This is the set of activities designed to maintain the conditions of use and operation of the machine, through various types of intervention (adjustments, visual inspection, recovery levels, etc.) performed by the maintenance technician or by the manufacturer’s technician at the frequency forecast.
Page 68: Extraordinary Maintenance
TD Code: ADM-001 Version: 03 USER MANUAL Date:03/10/2024 Page 68 de 69 Extraordinary maintenance This is the set of activities designed to maintain the conditions of use and operation of the machine, through various types of intervention (adjustments, changes, etc.) performed by qualified technicians in the event of failure or wear.
Page 69: History Of Modifications
TD Code: ADM-001 Version: 03 USER MANUAL Date:03/10/2024 Page 69 de 69 HISTORY OF MODIFICATIONS MODIFICATION HISTORY Edition Date Change made March 2024 Initial edition Header, sign and sterilization aclaration 19/09/2024 Name of the document Importance of this manual – IFU reference Indications, contraindications and warnings 03/10/2024 Safety features –...