adamo ROBOT V1.0 Instructions For Use Manual

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EDITED BY:

TECHNICAL RESPONSIBLE

SNA

Date: 01/10/2024

Signature:

Dssdfsa

ADAMO ROBOT - V 1.0

Instruction For Use

REVISED BY:

QUALITY MANAGER

SNA

Date: 01/10/2024

Signature:

RESPONSIBLE FOR

REGULATORY COMPLIANCE

SNA

Date: 01/10/2024

Signature:

APPROVED BY:

MANAGING DIRECTOR

CGI

Date: 01/10/2024

Signature:

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Summary of Contents for adamo ROBOT V1.0

Page 1 EDITED BY: REVISED BY: APPROVED BY: TECHNICAL RESPONSIBLE QUALITY MANAGER RESPONSIBLE FOR MANAGING DIRECTOR REGULATORY COMPLIANCE Date: 01/10/2024 Date: 01/10/2024 Date: 01/10/2024 Date: 01/10/2024 Signature: Signature: Signature: Signature: Dssdfsa ADAMO ROBOT - V 1.0 Instruction For Use...
Page 2: Table Of Contents
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 2 de 44 Table of contents INTRODUCTION ..........................5 ADMINISTRATIVE DATA ......................... 6 Product identification........................ 6 Manufacturer data ........................6 STATEMENS AND TESTING ......................7 Statement of delivery of the Instruction manual ..............7 Testing and Commissioning Certificate ..................
Page 3 Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 3 de 44 Intended use of the machine ....................24 Environmental Conditions ....................... 24 Energy supply .......................... 24 Products used for the operation ..................... 24 TRANSPORTATION AND HANDLING .................... 25 Transportation of the machine ....................
Page 4 Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 4 de 44 Violation error ......................... 41 Security error........................... 42 MAINTENANCE ..........................43 Cleaning ........................... 43 Every week ..........................43 Every year ..........................43 Extraordinary maintenance ..................... 44 DECOMMISSIONNIG ........................
Page 5: Introduction
We feel that your purchase will give you the meet the requirements you expect and please feel free to contact us whenever you need assistance, or you think you’re not getting the best of your ADAMO robot. We will be happy to offer you all our experience and knowledge to answer any question you may have.
Page 6: Administrative Data
UDI-DI 843702389701 Risk class Class IIa Rule/s 9, 11 Manufacturer data ADAMO ROBOT S.L. SRN: ES-MF-000028921 Tel (+34) 914 170 457 sales@adamorobot.com ▪ Fiscal address C/ Miguel Villanueva 2, 2D 26001 Logroño -Spain ▪ Main office C/ Manuel Tovar 49, 28034 Madrid -Spain ▪...
Page 7: Statemens And Testing
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 7 de 44 STATEMENS AND TESTING Statement of delivery of the Instruction manual The employer, to the extend required by applicable law on safety and health of workers at work, herby declares it has delivered to the authorized operators this Instructions For Use for the correct information and training on use and maintenance of the machine.
Page 8: Testing And Commissioning Certificate
INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 8 de 44 Before filling in the table, make a copy for future reference. Testing and Commissioning Certificate DATE: ____________________ Designation: ADAMO Robot Name: Model: Street: Serial No: City: Manufacture Year: State:...
Page 9: Statement And Medical Device
It is applied externally on one side of the machine indicated in Fig. 1 and states the following data, in a legible manner: • ADAMO ROBOT LOGO, MD, CE, UDI, CE, • NAME, ADDRESS OF MANUFACTURER • DESIGNATION OF THE MACHINE (MODEL) •...
Page 10: General
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 12 de 44 GENERAL 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 IFU ISO 7010-M002 Generic warning...
Page 11: State "Machine Off
(12). Specification of Expected Clinical Benefits ADAMO ROBOT® intended purpose is to support users in alleviating musculoskeletal pain and enhancing movement and daily function in patients, through physiological effects on muscle tension and neural signalling.
Page 12: Indications, Contraindications And Warnings
▪ ADAMO ROBOT® shall be placed on a flat surface that ensures stability in relation to the overall dimensions and weight respecting the minimum position referred in of the instructions for use.
Page 13: 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 14: Warnings
Warnings Users of ADAMO ROBOT® shall observe the following warnings when using the device ▪ For a thorough understanding of device functionality, the user shall read the instructions...
Page 15 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...
Page 16: Authorized Operators
Intended Patient Population ADAMO ROBOT® is intended to be used in adult patients, according to intended indications (see Section 2.3.10.1 Indications of this document) and who are not involved in the contraindications (see Section 2.3.10.2 Contraindications) of this document, and who can benefit from pressure and temperature-based therapies, under the supervision of a trained rehabilitation healthcare professionals.
Page 17: Manufacturer's Technician
(a) have registered their purchase with the Sales department of ADAMO Robot and (b) have completed the registration form completely and accurately, filling in the required fields with exact, complete and true information and have kept the registration code to be mentioned in the event of problems.
Page 18 Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 20 de 44 indicated in point 3) above. The above report must be accompanied by a regular purchase document (tax receipt or invoice). In the case of an Extended Warranty, the declaration must also indicate the registration code.
Page 19: Technical Description
Date: 01/10/2024 Page 21 de 44 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: DAMO ROBOT® key functional components...
Page 20 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 21: 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 Technical data ADAMO ROBOT V1.0 Power Supply (VAC / Hz) 230 / 50 Electric Consumption (A) 15,2...
Page 22: Intended Use Of The Machine
YOU MUST KEEP THE MACHINE OUT OF REACH OF UNAUTHORIZED PERSONS. INTENDED USE ADAMO ROBOT® is intended to support users in alleviating musculoskeletal pain and enhancing movement and daily function in patients, through physiological effects on muscle tension and neural signalling.
Page 23: Transportation And Handling
The packaging is a wooden box supported by a pellet and it has been specifically designed to fit the machine inside of it. The packaging contains: The ADAMO Robot An electric power cable Two (2) front wheel blocks The instruction manual A supplementary ramp The characteristics of the packaging are indicated in the following table.
Page 24 Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 26 de 44 Preparin g the Device for Transportation Before transporting the device, it is essential to follow a series of preparation steps to ensure the safety of the components during the journey. The main tasks involve releasing the compressor pressure and disconnecting the automatic compression motor.
Page 25: Handling Of Packaging With A Forklift Or Trans Pallet
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 27 de 44 Handling of packaging with a forklift or trans pallet IT IS MANDATORY THAT, IN THE RANGE OF HANDLING OPERATIONS, THERE ARE NO PEOPLE, ANIMALS AND/OR THINGS WEHOSE SAFETY CAN BE COMPROMISED ACCIDENTALLY. THE HANDLING OF THE PACKAGE CAN BE PERFORMED ONLY BY THE USE OF A TRANSPALLET OR FORKLIFT SUITABLE FOR USE.
Page 26 Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 28 de 44 The blocks are approximately the same length of the machine so the blocks must be placed manually such that both wheels are blocked from each side. IN ORDER TO ENSURE THAT THE AUTHORIZED OPERATORS OCCUPY THE WORK POSITIONS EXPECTED, IT IS MANDATORY TO ENSURE MINIMUM MEASURES OF POSITIONING AS SHOWN IN SECTION “DIMENSIONS OF THE MACHINE”.
Page 27: Installation
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 29 de 44 INSTALLATION General warnings IT IS COMPULSORY TO COMPLY WITH THE CORRECT PROCEDURES ASSEMBLY/ DISASSEMBLY AND CONNECTION OF COMPONENTS DESCRIBED IN THIS CHAPTER. THE MANUAL HANDLING MUST BE IN COMPLIANCE WITH THE REGULATIONS ON THE “MANUAL HANDLING OF LOADS”...
Page 28: Safety
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 30 de 44 SAFETY IN THE EVENT OF ANY SERIOUS INCIDENT RELATED TO THE USE OF THIS PRODUCT, THE USER OR PATIENT MUST IMMEDIATELY INFORM THE MANUFACTURER AND THE COMPETENT AUTHORITY OF THE MEMBER STATE WHERE THEY ARE LOCATED.
Page 29: Personal Protective Equipment (Ppe)
ADAMO Robot conform to the EN60601-1-2 standard for both immunity and emissions. Nevertheless, special precautions need to be considered: The use of accessories and cables other than those supplied or specified by ADAMO ROBOT, may result in increased emission or decreased immunity of the device.
Page 30: Residual Risks
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 32 de 44 The user might need to take mitigation measures, such as relocating or re-orienting the equipment. In certain occasions, when short voltage interruptions happen a protection magneto- thermic circuit braker in the air compressor inside the machine cuts off.
Page 31: Safety Signs
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 33 de 44 WARNINGS. Please, review carefully all CONTRAINDICATIONS and WARNINGS and follow instructions laid down in this document and shared with you during the user training. If you have any doubt about the use of the medical device, or the device is not working properly, DON`T USE IT and contact the manufacturer for complementary instructions.
Page 32: Use And Operation
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 34 de 44 USE AND OPERATION Places occupied by authorized operators The machine should be placed with the characteristics described in section “Intended use of the Machine”, placed on a flat floor that ensures stability in relation to the overall dimensions and to the weight (see section “TECHNICAL DESCRIPTION”).
Page 33: Installation And Connection. Operational Requirements
Date: 01/10/2024 Page 35 de 44 Installation and Connection. Operational Requirements This product includes software that can only be executed on the ADAMO ROBOT® device and under no circumstances on external or third-party devices. • Device dimensions: 0.7 m (width) x 1.38 m (length) x 1.55 m (height); 180 kg.
Page 34 Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 36 de 44 The stretcher must be placed in front of the machine and once checked that the robot is in its initial position the patient can lay down on the stretcher. It is recommended to use a stretcher with adjustable height.
Page 35 Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 37 de 44 After the treatment is finished the robot always returns to its initial safe position. In any case, the authorized operator must check that the cobot is in its initial safe position before the patient could move.
Page 36: On Screen Messages
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 38 de 44 ON SCREEN MESSAGES List of errors: • Collision • Activating motors • Robot in Fail (rearm needed) • Internal Temperature Level • Repeat the point •...
Page 37: Robot In Fail (Rearm Needed)
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 39 de 44 Robot in Fail (rearm needed) The different assumptions in which the robot will adopt security positions are explained below: If during a treatment session the patient or the staff touch the robot If during the "Teaching"...
Page 38: Repeat The Point
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 40 de 44 If the error temperature doesn’t decrease the following conditions should be checked: The ambient temperature of the room should comply with technical specifications. The cooling fans protection grids are not covered. If these conditions are met and the machine continues to overheat contact technical support.
Page 39: Communication Error
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 41 de 44 Communication error is an error message indicating a communication failure between the PC panel and There 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.
Page 40: Security Error
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 42 de 44 Security error A security error has been detected within the robot controller system. To ensure the safety and integrity of the system, it is recommended to restart the robot controller after a minute of waiting.
Page 41: Maintenance
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 43 de 44 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 42: Extraordinary Maintenance
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 44 de 44 To maintain the compressor in optimum conditions it must have the following maintenance using only manufacture’s spare parts: Replacement of air sterilization filter Replacement of humidity filter 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...
Page 43: Decommissionnig
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 45 de 44 DECOMMISSIONNIG Storage In the event that the machine should be stored for some time, you must place it in a safe environment, with a proper degree of temperature, humidity and protected from dust. Demolition Upon demolition of the machine, strictly follow the requirements in force in the country of demolition.
Page 44: History Of Modifications
Document Code: IFU ADM-001 INSTRUCTION FOR USE Version: 03 Date: 01/10/2024 Page 46 de 44 HISTORY OF MODIFICATIONS MODIFICATION HISTORY Edition Date Change made 02/03/2024 Initial edition Updated Technical description section. Header, sign, sterilization 19/09/2024 aclaration, adress ID name 01/10/2024 Administrative Data Indications, Contraindications and Warnings Installation and Connection.