WO2020208614A1 - An improved method for ensuring the correct functionality of an apparatus - Google Patents

An improved method for ensuring the correct functionality of an apparatus Download PDF

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Publication number
WO2020208614A1
WO2020208614A1 PCT/IB2020/053498 IB2020053498W WO2020208614A1 WO 2020208614 A1 WO2020208614 A1 WO 2020208614A1 IB 2020053498 W IB2020053498 W IB 2020053498W WO 2020208614 A1 WO2020208614 A1 WO 2020208614A1
Authority
WO
WIPO (PCT)
Prior art keywords
equipment
container
support element
barcode
data
Prior art date
Application number
PCT/IB2020/053498
Other languages
French (fr)
Inventor
Matteo BRUNORO
Davide BERELLO
Original Assignee
Brunoro, Paola
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Brunoro, Paola filed Critical Brunoro, Paola
Priority to EP20725909.4A priority Critical patent/EP3953874A1/en
Publication of WO2020208614A1 publication Critical patent/WO2020208614A1/en

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Classifications

    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/63ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for local operation
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3904External heart defibrillators [EHD]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3925Monitoring; Protecting
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61NELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N1/00Electrotherapy; Circuits therefor
    • A61N1/18Applying electric currents by contact electrodes
    • A61N1/32Applying electric currents by contact electrodes alternating or intermittent currents
    • A61N1/38Applying electric currents by contact electrodes alternating or intermittent currents for producing shock effects
    • A61N1/39Heart defibrillators
    • A61N1/3993User interfaces for automatic external defibrillators
    • GPHYSICS
    • G06COMPUTING; CALCULATING OR COUNTING
    • G06QINFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES; SYSTEMS OR METHODS SPECIALLY ADAPTED FOR ADMINISTRATIVE, COMMERCIAL, FINANCIAL, MANAGERIAL OR SUPERVISORY PURPOSES, NOT OTHERWISE PROVIDED FOR
    • G06Q10/00Administration; Management
    • G06Q10/20Administration of product repair or maintenance
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/40ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the management of medical equipment or devices, e.g. scheduling maintenance or upgrades
    • GPHYSICS
    • G16INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR SPECIFIC APPLICATION FIELDS
    • G16HHEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
    • G16H40/00ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices
    • G16H40/60ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices
    • G16H40/67ICT specially adapted for the management or administration of healthcare resources or facilities; ICT specially adapted for the management or operation of medical equipment or devices for the operation of medical equipment or devices for remote operation
    • AHUMAN NECESSITIES
    • A62LIFE-SAVING; FIRE-FIGHTING
    • A62CFIRE-FIGHTING
    • A62C37/00Control of fire-fighting equipment
    • A62C37/50Testing or indicating devices for determining the state of readiness of the equipment

Definitions

  • the present invention relates to an improved method for ensuring the correct functionality of a device, in particular of medical or safety equipment and preferably of a semiautomatic defibrillator.
  • these periodic checks and maintenance operations are aimed at ensuring the correct operation of the equipment at the crucial moment when there is an actual need for it.
  • the semi-automatic defibrillator which is a life-saving device to be used in case of cardiac arrest.
  • the adoption of this equipment is increasingly widespread, especially in public places and, in particular, it is mandatory by law in places where sports are practiced.
  • both the legislation, but also the common sense and experience, require that the defibrillator be subjected to periodic checks and maintenance in order to guarantee its correct functioning when there is a need to use it in an emergency situation.
  • the current procedure provides that the responsible operator fills out paper or electronic forms, without giving any real guarantee that he/she has actually gone in correspondence of the equipment to carry out the required check and maintenance operations.
  • US2015/1 12704, US2016/058996, US2013/087609 and FR2977961 describe methods for inspecting a defibrillator by acquiring its data by means of the optical detection means of a smartphone and by means of an APP loaded and executed in said smartphone.
  • these known methods do not ensure that the defibrillator has not been tampered with.
  • WO02/095675 describes the use, for a medical container, of an RFID tag with attached a conductive circuit to be broken or torn, thus defining in their combination a seal for said medical container.
  • the purpose of the invention is to propose an improved method to ensure the correct functionality of an equipment, preferably of a medical or safety equipment, which is an improvement and/or alternative compared to traditional ones.
  • Another purpose of the invention is to propose a method that prevents and avoids the risk of equipment malfunctions in case of need for its use in an emergency situation.
  • Another purpose of the invention is to propose a method that certifies the verification and/or maintenance intervention that the operator carries out on the equipment.
  • Another purpose of the invention is to propose a method that guarantees the uniformity of the check and/or maintenance procedures to be carried out.
  • Another purpose of the invention is to propose a method that induces greater operator responsibility towards the required check and/or maintenance procedures.
  • Another purpose of the invention is to propose a method that is independent of the characteristics and model of equipment.
  • Another purpose of the invention is to propose a method that is independent of the operator.
  • Another purpose of the invention is to propose a method that facilitates the operator in the required check and/or maintenance procedures.
  • Another purpose of the invention is to propose a method with an alternative characterization, both in functional and implementation terms, compared to traditional ones.
  • Another purpose of the invention is to propose a method that can be implemented simply, quickly and with low costs.
  • Another purpose of the invention is to propose a method that ensures that the equipment has not been tampered with and/or used.
  • Another purpose of the invention is to propose a method that also ensures the integrity of the casing of the equipment and/or the container in which the equipment is housed.
  • Another purpose of the invention is to propose an infrastructure to guarantee the correct functionality of an equipment, preferably of a medical or safety equipment, which is an improvement and/or alternative compared to traditional ones.
  • Another purpose of the invention is to propose an infrastructure that allows to certify the check and/or maintenance intervention that the operator carries out on the equipment and, at the same time, certify that the equipment has not been tampered with and/or already used. All these purposes, considered both individually and in any combination, are achieved, according to the invention, by means of a method with the features indicated in claim 1.
  • Figure 1 shows a schematic view of a first embodiment of the method according to the invention
  • Figure 2 shows it in schematic view in a second embodiment
  • Figure 3 shows it in schematic view in a third embodiment
  • Figure 4 shows a first screen visible on the display of the acquisition device used in the method according to the invention.
  • Figure 5 shows a second screen of the same
  • Figure 6 shows the band support element to be applied on an equipment
  • Figure 7 shows the band support element in a different embodiment
  • Figure 8 shows a front view of the band support element of fig. 7 applied to the equipment container.
  • the method 1 according to the invention comprises an equipment 2, whose correct functionality is to be guaranteed, which is substantially of the traditional type and can be of any type or model.
  • the equipment 2 is an automatic or semi-automatic defibrillator, and in particular it is an "external automatic defibrillator” (also known as “AED”), but it could also be any medical and/or safety device (such as for example a fire extinguisher) which requires, by law and/or practice, periodic checks and/or maintenance.
  • AED ternal automatic defibrillator
  • a fire extinguisher any medical and/or safety device which requires, by law and/or practice, periodic checks and/or maintenance.
  • the method according to the invention also requires a portable device 10 (for example, mobile phone, smartphone, tablet, etc.) which is provided with means 12 for acquiring, near the defibrillator 2, a series of data relating to and/or representative of the defibrillator itself.
  • a portable device 10 for example, mobile phone, smartphone, tablet, etc.
  • means 12 for acquiring, near the defibrillator 2, a series of data relating to and/or representative of the defibrillator itself.
  • the acquisition means 12 of said portable device 10 comprise:
  • - optical detection means 14 for scanning and/or acquiring at least a barcode 16 which contains - in coded form - said data relating to and/or representative of the equipment 2, and/or - short-range wireless transceiver means for querying and/or reading the content of at least one electronic label 17 which contains data relating to and/or representative of the equipment 2.
  • the barcode 16 and/or the electronic label 17 are installed/mounted on a support element 21 which is removably associated with the equipment 2 and/or with the container 19, in which said equipment 2 and any other components and/or accessories are housed.
  • the support element 21 provided with the barcode and/or the electronic label 17 is configured to act as a seal of guarantee and/or security of the integrity of the equipment 2, and/or of said container 19, thus certifying that said equipment 2 and/or said container 19 have not been tampered with and/or already used and/or opened.
  • the barcode 16 and/or the electronic label 17 are installed/mounted on the support element 21 so that, in order to dissociate them from said support element, it is necessarily and inevitably caused an irreversible damage of said barcode and/or of said label and/or of the support element itself.
  • the support element 21 is configured so that it can have and pass between two configurations:
  • a first configuration in which the support element 21 can be dissociated/removed from the equipment 2, and/or from the container 19 for housing the equipment and/or other components and/or accessories, only by causing irreversible damage to the support element itself and/or to the installed barcode 16 and/or to the installed electronic label 17,
  • the support element 21 can be dissociated/removed from the equipment 2, or from the housing container 19, without causing an irreversible damage to the support element itself and/or to the installed barcode 16 and/or to the installed electronic label 17, so that it can then be re applied/associated to the equipment 2 and/or to the housing container 19.
  • the support element 21 is configured to be applied/associated with the equipment 2 and/or its container 19 so that:
  • said equipment 2 for example partially covering the graphical interface for displaying or controlling the equipment
  • the support element 21 is configured so that its passage between said two configurations can be carried out and/or caused only following the correct reception of a wireless command signal sent from the outside by said device 10, and in particular by the short-range wireless transceiver means of said device 10.
  • the support element 21 is also configured so as to always allow its rapid dissociation/removal from the equipment 2 or from the container 19, in which said equipment and/or any other components and/or accessories are housed, by inevitably and always causing irreversible damage to the support element itself and/or to the barcode 16 and/or to the electronic label 17 installed on said element.
  • the support element 21 can be quickly dissociated/removed, making it then no longer reusable and/or in any case no longer suitable for being re associated/reapplied to the equipment 2 or to the container 19.
  • this allows rapid access to the equipment 2 if it is required its use in emergency conditions and, at the same time, it constitutes a clear evidence of the fact that it has been used, and which therefore it must be checked again (or reloaded/reset) before any subsequent use.
  • the barcode 16 is an identification code consisting of a set of graphic elements that define, in a coded form, a series of data relating to and/or representative of the equipment itself.
  • the barcode 16 can be linear (continuous or discrete) or, advantageously, it is a two-dimensional code, preferably a matrix code.
  • the electronic tag 17 is an NFC or RFID tag.
  • the electronic label 17 comprises a transponder.
  • the electronic label 17 can be active, passive, semi-passive or semi-active.
  • the electronic label 17 is configured to operate at a well-defined frequency band, in particular regulated by ISO standards.
  • the electronic label 17 comprises a microchip equipped with a radio antenna.
  • the electronic label 17 comprises a memory which, at least in part, is writable following an unlocking procedure.
  • the electronic label 17 is of the "read only" type or "write once, read many" type.
  • the electronic label 17 is password protected and is encrypted.
  • the electronic label 17 is a smart label.
  • said short-range wireless transceiver means for interrogating and/or reading the content of at least one electronic label 17 include, for example, an RFID reader.
  • the short range wireless transceiver means, not shown, of the device 10 use NFC technology (from English “Near Field Communication”) or RFID transponder (from English “Radio-Frequency IDentification”) or the standard Bluetooth. Therefore, by bringing the device 10 closer to the electronic label 17, the former is able to acquire the data contained in said label and relative/representative of defibrillator 2.
  • these acquisition means 12 of the device 10 comprise optical detection means 14, for example a digital camera, for acquiring, in the form of at least one digital image (photograph) 1 1 of the defibrillator 2, a series of data relating to and/or representative of the defibrillator itself.
  • optical detection means 14 for example a digital camera, for acquiring, in the form of at least one digital image (photograph) 1 1 of the defibrillator 2, a series of data relating to and/or representative of the defibrillator itself.
  • said acquisition means 12 can comprise a barcode reader, for example of the type that uses laser beams, or a LED bar and a CCD sensor, or of the type that uses photographic technology.
  • said acquisition means 12 can be provided with its own memory for storing the data before their transfer to the memory and/or processor of the portable device 10.
  • said acquisition means 12 can be provided with a wireless or via cable transmitter for sending data to a receiver associated and/or integrated in the portable device 10.
  • the acquisition means 12 can be external but connected to the portable device 10. Conveniently, the acquisition means 12 are integrated in the portable device 10.
  • the representative data of defibrillator 2 are encoded within the barcode 16.
  • the barcode 16 can be associated with the external surface of the container/casing 19 of the defibrillator 2, in a suitably and easily visible position.
  • the barcode 16 is of two-dimensional, preferably matrix type; advantageously, the barcode 16 is a "QR code" (acronym deriving from the English words "Quick Response") or a "Data Matrix” code or any other two-dimensional barcode which is composed of black modules arranged inside a square or rectangular shape.
  • the barcode 16 can also have modules of different colors and, preferably, it can be of the type in which the data are also coded by means of the color of said modules.
  • the use of the barcode 16 - preferably two-dimensional matrix barcode - allows to store, in a single and secure way, a plurality of data relating to and/or representative of the defibrillator 2 within a single image.
  • the barcode 16 and/or the electronic label 17 can act as a marker to activate on the device 10 suitable augmented reality applications configured to superimpose on the screen 15 of the device itself multimedia contents (for example video, audio, 3D objects, etc.) relating to the management of an emergency situation, the use of the defibrillator 2 and/or the methods for carrying out the check and maintenance operations to be carried out on defibrillator 2.
  • suitable augmented reality applications configured to superimpose on the screen 15 of the device itself multimedia contents (for example video, audio, 3D objects, etc.) relating to the management of an emergency situation, the use of the defibrillator 2 and/or the methods for carrying out the check and maintenance operations to be carried out on defibrillator 2.
  • the support element 21 for the barcode 16 and/or the electronic label 17 acts as a security seal and guarantees the integrity of the casing of the defibrillator 2 and/or of the container 19, in which the defibrillator 2 and/or any other components or accessories are housed, so as to certify that the defibrillator and/or the container 19 has not been used and/or tampered with and/or opened.
  • the support element 21 for the barcode 16 and/or the electronic label 17 acts as a seal in the sense that it is applied/associated - preferably wrapped around - to the casing of the defibrillator 2 and/or to the container 19, in which said defibrillator and/or any other components are housed, so as not to allow the use of the defibrillator 2 or the access to the inside said container 19, and so that the only way to use/open them is to cause the irreversibly breaking/tampering with of said support element 21 which acts as a seal.
  • the support element 21 on which the barcode 16 and/or the electronic label 17 are permanently installed acts as a seal in the sense that it is configured to be applied to the casing of the defibrillator 2 and/or to the housing container 19, so as not to allow to act on said defibrillator or to access inside the container, if not breaking or tampering with said seal.
  • said support element 21 is fixed, mounted and/or applied to the defibrillator 2 casing in a position such as to act as a seal of guarantee and/or safety.
  • said support element 21 comprises a band 23 which is applied or is wrapped around the defibrillator 2 (i.e. its casing) and/or the container 19 in which said defibrillator 2 is housed.
  • said band 23 can have an annular conformation or be of the belt type (i.e. its ends are intended to be removably joined together).
  • the barcode 16 and/or an electronic label 17 is applied and/or mounted on said band 23
  • said barcode 16 and/or said electronic label 17 is removably applied on said band 23.
  • the band 23 can include at least one electronic lock 24.
  • the electronic lock 24 and/or the band 23 are configured so that:
  • the band 23 can be removed from the defibrillator 2, or from the container 19, only by causing the irreversible damage to the band itself,
  • the band 23 can be removed from the defibrillator 2, or from the container 19, without causing irreversible damage to the band itself, so that it can then be re-applied or is wound to defibrillator 2 and/or to container 19.
  • the passage of the electronic lock 24 from the activated closed condition to the deactivated open condition occurs following a wireless command signal sent from the outside by said device 10, and in particular by the short-range wireless transceiver means of said device 10.
  • the passage of the electronic lock 24 from the deactivated open condition to the active close condition takes place mechanically in an automatic way (for example by bringing/joining together two ends of the band in which respective components of said lock 24 are mounted) and/or following to a wireless command signal sent from the outside by said device 10, and in particular by the short-range wireless transceiver means of said device 10.
  • the electronic lock 24 is configured so that, each time it passes from the activated close condition to the deactivated open condition, a corresponding electronic circuit - which is integrated and/or connected to said lock - automatically generates a corresponding signal which is transmitted to the device 10 (preferably by means of the short- range wireless transceiver means of the device 10), thus identifying a corresponding event which advantageously is then stored in the device 10 and/or which is transmitted through the communication means 22 of the device 10 to the central remote processing unit 30, to be thus stored in the latter.
  • the electronic lock 24 is mounted on the band 23 - for example at two opposite ends of said band 23 - so that, when the lock is in the activated closed condition, it prevents the use of the defibrillator 2, for example preventing access to the defibrillator's graphic interface (display and/or input), or preventing the opening of the defibrillator casing, or even preventing the opening of the container in which the defibrillator 2 is housed.
  • the electronic lock 24 can be provided with an electronic control unit which is associated with short-range wireless reception means, so that the opening/unlocking of the lock 24 is associated with a signal from the short range wireless transceiver means of the device 10.
  • the opening of the electronic lock 24 can be caused only by the approach of the device 10. Then, a subject with said portable device 10, who has gone near the defibrillator 2, can unlock the lock 24 (i.e. causing its passage from the activated close condition to the deactivated open condition), and can therefore remove the band 23 without damaging it, in order to check/control the status and operation of the defibrillator 2 or of the other components/accessories housed in the container 19.
  • this check can then reapply the band 23 around the defibrillator and/or the container 19; then, the lock 24 - automatically or following to a further command sent from the outside through/by means of the device 10 - is brought back to the activated close condition.
  • said band 23 is provided with quick coupling/uncoupling means.
  • said quick coupling/uncoupling means are associated with electronic activation means which are controlled by a signal received from the outside (and transmitted by the wireless transceiver means of said device) or by a command that is received from the outside by said electronic label 17.
  • the band 23 can comprise means configured to allow its rapid removal from the defibrillator 2, or from the container 19, however causing irreversible damage to the band itself.
  • these means allow the band 23 to be quickly removed, making it then no longer reusable.
  • these means comprise for example one or more tear points 26 for quickly opening and removing the band 23 that wraps around the defibrillator 2 or the container 19.
  • this allows quick access to the defibrillator 2 if its use is required in emergency conditions and, at the same time, constitutes a clear evidence of the fact that it has been used, and that therefore it must then be checked (or recharged) before any subsequent use.
  • the band 23 can also be printed (for example by means of a traditional printed tag), or associated by means of an electronic label 17 or a barcode 16, the information which allows the univocal identification of the defibrillator 2 to which the belt 23 is associated.
  • the electronic label 17 and/or the barcode 16 can be removable and reusable.
  • the data contained in the electronic label 17 and/or which are encoded in the barcode 16 can include the serial number, the type and other characteristics or information relating to the defibrillator 2. More in detail, preferably, the data relating to the defibrillator 2 can concern for example the date of construction, the firmware versions, the versions of the software application, the serial number, the purchase date, the product warranty, the expiry date of the batteries and/or electrodes, and/or other data related to the defibrillator and useful for the purpose.
  • the defibrillator 2 is associated with, or is incorporated in, a short-range wireless transceiver unit 18 (i.e. in the order of tens of centimeters up to one meter), such as that which uses NFC technology (from the English “Near Field Communication ”) or the Bluetooth standard, or a transponder such as RFID (from the English" Radio-Frequency I Dentification ").
  • a short-range wireless transceiver unit 18 i.e. in the order of tens of centimeters up to one meter
  • NFC technology from the English “Near Field Communication ”
  • the Bluetooth standard or a transponder such as RFID (from the English” Radio-Frequency I Dentification ").
  • RFID from the English” Radio-Frequency I Dentification
  • the short range wireless transceiver means of the device 10 are also configured to transmit, receive and/or exchange data with the short range transceiver unit 18 of the defibrillator 2. Therefore, bringing the device 10 closer to the defibrillator 2, the former is capable of acquiring a data packet 20 relating to and/or representative of the defibrillator 2 and sent by the short-range transceiver unit 18 of the latter.
  • the short-range wireless transceiver means of the device 10 are configured to query and/or receive both the data contained in the electronic label 17 and the data packet 20 sent by the short-range wireless transceiver unit 18 of the defibrillator 2.
  • the short range wireless transceiver means of the device 10 comprise the same data transceiver module which interfaces both with the electronic label 17 and with the wireless transceiver unit 18 of the defibrillator.
  • the short-range wireless transceiver means of the device 10 comprise two different data transceiver modules and, in particular, a first module which interfaces with the electronic label 17 (for example by means of the NFC standard) and a different/second module that interfaces with the defibrillator's wireless transceiver unit 18 (for example via the Bluetooth standard).
  • said two transceiver modules are configured for data transmission and/or reception on frequencies or frequency bands which are different between the two modules.
  • said two transceiver modules are configured for data transmission and/or reception with different communication protocols and/or standards.
  • said two transceiver modules are configured for data transmission and/or reception with different communication technologies
  • the acquisition device 10 is also provided with a processor which is configured to represent on the display 15 of the device itself the data, relating to and/or representative of the defibrillator 2, which have been acquired by means of the acquisition means 12.
  • a program is loaded and executed in the processor of the acquisition device 10 to represent on the display 15 the image (photograph) 11 acquired by means of the optical detection means 14.
  • a suitable program for the reading/decoding of barcode 16 which has been acquired by the device itself through said optical detection means 14 can be loaded and executed inside the processor of the device 10.
  • This reading/decoding program can be also configured to represent the barcode 16 on the display 15 of the device itself (see fig. 2) or, preferably, to represent the data contained in the barcode in an orderly and suitably formatted manner (see fig. 4).
  • a suitable program can be loaded and executed inside the processor of the device 10 to represent on the display 15 of the device, in a formatted and tidy way, the data contained in the electronic label 17 and acquired by means of the transceiver means of said device 10.
  • a suitable program can be loaded and executed inside the processor of the device 10 to represent on the display 15 of the device itself, in a formatted and tidy way, the data packet 20 transmitted by the transceiver unit 18 of the defibrillator 2 to the transceiver means of the device 10.
  • the program for processing and representing data which was acquired by means 12, is a suitable mobile software application (APP) loaded and executed on a smartphone or tablet, even without requiring a connection to the internet (i.e. offline).
  • APP mobile software application
  • the data relating to and/or representative of the defibrillator 2 and acquired by means of the acquisition means 12 of the device 10 are automatically stored locally within a memory unit provided in the device itself.
  • the device 10 is provided with communication means 22 for sending the image 1 1 and/or the barcode 16 and/or the data contained in the electronic label 17 and/or the data packet 20 (which is sent by the unit 18 of the defibrillator 2) acquired through the transceiver means, to a remote processing unit 30, for example a remote server computer or a cloud data system.
  • these communication means 22 can use the technology of cellular mobile telephony (with standards such as, for example, according to the GSM, GPRS, LTE, NB-loT standards, etc. or Wmbus, LoRa technologies, etc.) and/or Internet network.
  • the program for reading/decoding the matrix two-dimensional barcode 16 and/or the data contained in the electronic label 17 and/or the data packet 20 is also loaded and executed inside the remote processing unit 30 sent by the unit 18 of the defibrillator 2.
  • a program is loaded and executed to represent on the display 32, associated with the remote processing unit 30, the image 11 and/or the two-dimensional barcode 16 and/or to display, in an orderly and a suitably formatted way, the data contained in the two-dimensional barcode 16 and/or in the electronic label 17 and/or in the data packet 20.
  • the data relating to and/or representative of defibrillator 2, which were acquired through the means 12 of the device 10 and which were transmitted to the remote unit 30, are automatically stored within the same remote unit.
  • this storing is carried out in an organized way in order to facilitate the subsequent interrogation and consultation of the data.
  • the data storage within the remote unit 30 is carried out so that the same data cannot be changed or overwritten, thus guaranteeing their immutability over time.
  • this can be done using a shared and immutable data structure of the blockchain type.
  • the barcode 16 or the data contained in the electronic label 17 or the data packet 20 transmitted by the unit 18 of the defibrillator 2 can also contain an Internet address and, appropriately, the reading program can be configured to automatically send back to the operator, through the internet and suitably with an http or preferably https protocol (i.e. using an encrypted connection for example according to the TLS or SSL cryptographic protocols), to the page of the website corresponding to the above mentioned internet address.
  • an http or preferably https protocol i.e. using an encrypted connection for example according to the TLS or SSL cryptographic protocols
  • the information contained in the two-dimensional barcode 16 or in the data packet 20 is represented in an orderly and suitably formatted manner.
  • a software module can be loaded and executed in the processor of the acquisition device 10 or in the remote processing unit 30 which receives the data of the defibrillator 2 acquired by said means 12 and, on the basis of a series of historical data stored and contained, for example, in a database and/or on the basis of any further processing, provides a series of information useful for the operator who, for example, is carrying out check or maintenance operations, such as the type of maintenance operation to be performed on the basis of the history of previous interventions carried out, etc.
  • the device 10 is provided with a GNSS receiver, preferably GPS but could also be based on other systems (GLONASS, Galileo, IRNSS, BEIDOU, QZSS, etc.).
  • the GNSS receiver is connected to the processor of the device 10 and comprises an antenna for receiving satellite signals and provides, at the output, the current position (i.e. the geographic coordinates in terms of latitude and longitude) of the device 10 on the earth's surface.
  • the GNSS receiver of the device 10 is suitably activated - preferably automatically - to provide the position (i.e. the geographic coordinates) of the device itself, which therefore substantially corresponds to the one of the defibrillator 2 to which the device 10 necessarily had to approach in order to acquire said data.
  • the GNSS receiver of the device 10 also outputs a representative value of the instant of acquisition (i.e. date and time) of the satellite signals.
  • the position values (i.e. the geographical coordinates) detected by the device 10 are sent by the latter to a central remote unit where they are conveniently stored and collected in a database provided with means for its consultation and, advantageously, this allows to automatically create a computerized geolocation portal for all defibrillators 2 present in a certain area.
  • a database provided with means for its consultation and, advantageously, this allows to automatically create a computerized geolocation portal for all defibrillators 2 present in a certain area.
  • the fact that the position values are integrated with the moment of acquisition of the same, allows to provide also information relating to the temporal update of the computerized geolocation portal.
  • the acquisition device 10 can interface with the geolocation computer portal so that a map 40 of the defibrillators 2 present in a certain area is shown on the display 15 of the device itself.
  • the display 15 of the acquisition device 10 can also be represented in a clear and formatted way information for managing an emergency situation, information on the use of the defibrillator 2, information relating to the methods of carrying out the verification and maintenance operations to be carried out on defibrillator 2. More specifically, in the case of defibrillator 2, the check and maintenance procedures are carried out on the electrodes and on the battery of the same, on the test procedure, on the status of the indicator lights, etc.
  • a device is also loaded and executed in the device 10 which, based on the history of the data acquired by the means 12 and suitably stored, sends notifications/warnings on the display 15 of the same in order to remind the operator when and what check and maintenance operations are necessary.
  • a unique identification code is also sent to the remote unit 30 (for example, its IMEI, SDNI or MS ISDN code) relating to the device 10 which performed the acquisition of the data relating to and/or representative of the defibrillator.
  • the access by the operator to the main screen of the acquisition device 10 is subject to a correct authentication by the operator himself, for example through an introductory screen in which the operator is asked to enter, for example by means of the input means of the user interface with which the device is equipped, a suitable authentication password.
  • the authentication and identification of the operator can be carried out by digital electronic signature, by biometric recognition through the means 12 of the device 10 and/or by inserting a pin or by inserting a code sent, for example by text message or a messaging application based on the internet connection, on the device 10.
  • the identification of the operator who acquired the image and/or data it is built a historical archive of the operators who carried out the check and/or maintenance interventions.
  • the present invention also relates to the mobile software application (APP) which is configured to implement the above described method and which is loaded and executed in the processor of said portable device 10.
  • APP mobile software application
  • the present invention also relates to a software application which is configured to implement the above described method and which is loaded and executed in the processor of said central remote processing unit 30.
  • the present invention also relates to a hardware infrastructure which is configured to implement the above described method.
  • the present solution provides for sending the acquired data, and contained in the barcode 16 and/or in the electronic label 17, to a central remote processing unit 30 to be stored inside said unit, thus certifying that a person equipped with a portable device went near said equipment to be checked/verified.

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Abstract

Method for ensuring the correct functionality of an equipment (2), particularly of a medical and/or safety equipment and preferably of a semi-automatic defibrillator, comprising the steps of: - going physically near said equipment (2) with a portable device (10) which is equipped with its own processor and means (12) for acquiring, near said equipment (2), data relating to and/or representative of the equipment itself, - activating said means (12) to acquire, near said equipment (2), said data relating to and/or representative of the equipment itself, - sending the data so acquired, by means of communication means (22) with which said portable device (10) is provided, to a central remote processing unit (30) to be stored inside said unit, thus certifying that a subject with said portable device (10) went near said equipment (2), and characterized in that said acquisition means (12) of said portable device (10) comprise: - optical detection means (14) for scanning and/or acquiring at least one barcode (16) which contains said data relating to and/or representative of said equipment (2), and/or - short-range wireless transceiver means for reading the content of at least one electronic label (16) which contains relating to and/or representative data of said equipment (2), and also characterized in that said barcode (16) and/or said electronic label (17) are installed/mounted on a support element (21) which is removably applied/associated to the equipment (2) and/or to the container (19), in which said equipment (2) and any other components and/or accessories are housed, said support element (21) being configured so as to act as a seal of guarantee and/or security of the integrity of the equipment (2) and/or of said container (19), so as to certify that said equipment (2) and/or said container (19) have not been tampered with and/or already used and/or opened.

Description

AN IMPROVED METHOD FOR ENSURING THE CORRECT FUNCTIONALITY OF AN APPARATUS.
The present invention relates to an improved method for ensuring the correct functionality of a device, in particular of medical or safety equipment and preferably of a semiautomatic defibrillator.
It is known that some equipment, to be used both for medical purposes (such as defibrillators) and for safety purposes (for example fire extinguishers), requires a series of periodic checks aimed to check the normal and correct operation of the devices themselves, and require the execution of a series of periodic maintenance operations aimed at maintaining the correct functionality of these devices during their life cycle.
Suitably, these periodic checks and maintenance operations are aimed at ensuring the correct operation of the equipment at the crucial moment when there is an actual need for it.
Among these devices there is, for example, the semi-automatic defibrillator, which is a life-saving device to be used in case of cardiac arrest. The adoption of this equipment is increasingly widespread, especially in public places and, in particular, it is mandatory by law in places where sports are practiced. Conveniently, both the legislation, but also the common sense and experience, require that the defibrillator be subjected to periodic checks and maintenance in order to guarantee its correct functioning when there is a need to use it in an emergency situation.
Nowdays these checks are based essentially and only on the skills and common sense of the person who is responsible for the proper functioning of this equipment. In view of this, it is understood that this procedure is not satisfactory as, in addition to being slow and laborious, it is highly dependent on the operator, with a high risk of errors and inaccuracies, particularly when the operators who are not particularly experienced.
In addition, the current procedure provides that the responsible operator fills out paper or electronic forms, without giving any real guarantee that he/she has actually gone in correspondence of the equipment to carry out the required check and maintenance operations.
US2015/1 12704, US2016/058996, US2013/087609 and FR2977961 describe methods for inspecting a defibrillator by acquiring its data by means of the optical detection means of a smartphone and by means of an APP loaded and executed in said smartphone. However, these known methods do not ensure that the defibrillator has not been tampered with. WO02/095675 describes the use, for a medical container, of an RFID tag with attached a conductive circuit to be broken or torn, thus defining in their combination a seal for said medical container.
The purpose of the invention is to propose an improved method to ensure the correct functionality of an equipment, preferably of a medical or safety equipment, which is an improvement and/or alternative compared to traditional ones.
Another purpose of the invention is to propose a method that prevents and avoids the risk of equipment malfunctions in case of need for its use in an emergency situation.
Another purpose of the invention is to propose a method that certifies the verification and/or maintenance intervention that the operator carries out on the equipment.
Another purpose of the invention is to propose a method that guarantees the uniformity of the check and/or maintenance procedures to be carried out.
Another purpose of the invention is to propose a method that induces greater operator responsibility towards the required check and/or maintenance procedures.
Another purpose of the invention is to propose a method that is independent of the characteristics and model of equipment.
Another purpose of the invention is to propose a method that is independent of the operator.
Another purpose of the invention is to propose a method that facilitates the operator in the required check and/or maintenance procedures.
Another purpose of the invention is to propose a method with an alternative characterization, both in functional and implementation terms, compared to traditional ones.
Another purpose of the invention is to propose a method that can be implemented simply, quickly and with low costs.
Another purpose of the invention is to propose a method that ensures that the equipment has not been tampered with and/or used.
Another purpose of the invention is to propose a method that also ensures the integrity of the casing of the equipment and/or the container in which the equipment is housed.
Another purpose of the invention is to propose an infrastructure to guarantee the correct functionality of an equipment, preferably of a medical or safety equipment, which is an improvement and/or alternative compared to traditional ones.
Another purpose of the invention is to propose an infrastructure that allows to certify the check and/or maintenance intervention that the operator carries out on the equipment and, at the same time, certify that the equipment has not been tampered with and/or already used. All these purposes, considered both individually and in any combination, are achieved, according to the invention, by means of a method with the features indicated in claim 1.
The present invention is further clarified below in a preferred form of practical embodiment thereof, given purely by way of a non-limiting example with reference to the attached drawings, in which:
Figure 1 shows a schematic view of a first embodiment of the method according to the invention,
Figure 2 shows it in schematic view in a second embodiment,
Figure 3 shows it in schematic view in a third embodiment,
Figure 4 shows a first screen visible on the display of the acquisition device used in the method according to the invention, and
Figure 5 shows a second screen of the same,
Figure 6 shows the band support element to be applied on an equipment,
Figure 7 shows the band support element in a different embodiment,
Figure 8 shows a front view of the band support element of fig. 7 applied to the equipment container.
As can be shown from the figures, the method 1 according to the invention comprises an equipment 2, whose correct functionality is to be guaranteed, which is substantially of the traditional type and can be of any type or model.
Preferably, the equipment 2 is an automatic or semi-automatic defibrillator, and in particular it is an "external automatic defibrillator" (also known as "AED"), but it could also be any medical and/or safety device (such as for example a fire extinguisher) which requires, by law and/or practice, periodic checks and/or maintenance.
The method according to the invention is described below with specific reference to an automatic or semiautomatic defibrillator 2, but it is understood that this method can also be used appropriately for the other devices mentioned above.
The method according to the invention also requires a portable device 10 (for example, mobile phone, smartphone, tablet, etc.) which is provided with means 12 for acquiring, near the defibrillator 2, a series of data relating to and/or representative of the defibrillator itself.
Conveniently, the acquisition means 12 of said portable device 10 comprise:
- optical detection means 14 for scanning and/or acquiring at least a barcode 16 which contains - in coded form - said data relating to and/or representative of the equipment 2, and/or - short-range wireless transceiver means for querying and/or reading the content of at least one electronic label 17 which contains data relating to and/or representative of the equipment 2.
The barcode 16 and/or the electronic label 17 are installed/mounted on a support element 21 which is removably associated with the equipment 2 and/or with the container 19, in which said equipment 2 and any other components and/or accessories are housed. The support element 21 provided with the barcode and/or the electronic label 17 is configured to act as a seal of guarantee and/or security of the integrity of the equipment 2, and/or of said container 19, thus certifying that said equipment 2 and/or said container 19 have not been tampered with and/or already used and/or opened.
Preferably, the barcode 16 and/or the electronic label 17 are installed/mounted on the support element 21 so that, in order to dissociate them from said support element, it is necessarily and inevitably caused an irreversible damage of said barcode and/or of said label and/or of the support element itself.
Suitably, the support element 21 is configured so that it can have and pass between two configurations:
- a first configuration (see fig. 8) in which the support element 21 can be dissociated/removed from the equipment 2, and/or from the container 19 for housing the equipment and/or other components and/or accessories, only by causing irreversible damage to the support element itself and/or to the installed barcode 16 and/or to the installed electronic label 17,
- a second configuration (see for example fig. 7) in which the support element 21 can be dissociated/removed from the equipment 2, or from the housing container 19, without causing an irreversible damage to the support element itself and/or to the installed barcode 16 and/or to the installed electronic label 17, so that it can then be re applied/associated to the equipment 2 and/or to the housing container 19.
Suitably, furthermore, the support element 21 is configured to be applied/associated with the equipment 2 and/or its container 19 so that:
- in said first configuration it prevents the use of said equipment 2 (for example partially covering the graphical interface for displaying or controlling the equipment) and/or the access to the inside of the container 19,
- in said second configuration it allows the use of said equipment and/or the access to the inside the container.
Conveniently, furthermore, the support element 21 is configured so that its passage between said two configurations can be carried out and/or caused only following the correct reception of a wireless command signal sent from the outside by said device 10, and in particular by the short-range wireless transceiver means of said device 10.
Conveniently, moreover, the support element 21 is also configured so as to always allow its rapid dissociation/removal from the equipment 2 or from the container 19, in which said equipment and/or any other components and/or accessories are housed, by inevitably and always causing irreversible damage to the support element itself and/or to the barcode 16 and/or to the electronic label 17 installed on said element. Basically, at least when it is in its first configuration, the support element 21 can be quickly dissociated/removed, making it then no longer reusable and/or in any case no longer suitable for being re associated/reapplied to the equipment 2 or to the container 19. Suitably, this allows rapid access to the equipment 2 if it is required its use in emergency conditions and, at the same time, it constitutes a clear evidence of the fact that it has been used, and which therefore it must be checked again (or reloaded/reset) before any subsequent use.
Conveniently, the barcode 16 is an identification code consisting of a set of graphic elements that define, in a coded form, a series of data relating to and/or representative of the equipment itself.
Conveniently, the barcode 16 can be linear (continuous or discrete) or, advantageously, it is a two-dimensional code, preferably a matrix code.
Preferably, the electronic tag 17 is an NFC or RFID tag. Preferably, the electronic label 17 comprises a transponder. Suitably, the electronic label 17 can be active, passive, semi-passive or semi-active. Suitably, the electronic label 17 is configured to operate at a well-defined frequency band, in particular regulated by ISO standards. Preferably, the electronic label 17 comprises a microchip equipped with a radio antenna. Preferably, the electronic label 17 comprises a memory which, at least in part, is writable following an unlocking procedure. Preferably, the electronic label 17 is of the "read only" type or "write once, read many" type. Suitably, the electronic label 17 is password protected and is encrypted. Suitably, the electronic label 17 is a smart label.
Conveniently, said short-range wireless transceiver means for interrogating and/or reading the content of at least one electronic label 17 include, for example, an RFID reader.
Conveniently, the short range wireless transceiver means, not shown, of the device 10 use NFC technology (from English "Near Field Communication") or RFID transponder (from English "Radio-Frequency IDentification") or the standard Bluetooth. Therefore, by bringing the device 10 closer to the electronic label 17, the former is able to acquire the data contained in said label and relative/representative of defibrillator 2.
Advantageously, as shown in fig. 1 , these acquisition means 12 of the device 10 comprise optical detection means 14, for example a digital camera, for acquiring, in the form of at least one digital image (photograph) 1 1 of the defibrillator 2, a series of data relating to and/or representative of the defibrillator itself.
Conveniently, said acquisition means 12 can comprise a barcode reader, for example of the type that uses laser beams, or a LED bar and a CCD sensor, or of the type that uses photographic technology.
Advantageously, said acquisition means 12 can be provided with its own memory for storing the data before their transfer to the memory and/or processor of the portable device 10. Advantageously, said acquisition means 12 can be provided with a wireless or via cable transmitter for sending data to a receiver associated and/or integrated in the portable device 10.
Conveniently, the acquisition means 12 can be external but connected to the portable device 10. Conveniently, the acquisition means 12 are integrated in the portable device 10.
Advantageously, the representative data of defibrillator 2 are encoded within the barcode 16.
Preferably, the barcode 16 can be associated with the external surface of the container/casing 19 of the defibrillator 2, in a suitably and easily visible position. Advantageously, the barcode 16 is of two-dimensional, preferably matrix type; advantageously, the barcode 16 is a "QR code" (acronym deriving from the English words "Quick Response") or a "Data Matrix" code or any other two-dimensional barcode which is composed of black modules arranged inside a square or rectangular shape. Advantageously, the barcode 16 can also have modules of different colors and, preferably, it can be of the type in which the data are also coded by means of the color of said modules. Advantageously, the use of the barcode 16 - preferably two-dimensional matrix barcode - allows to store, in a single and secure way, a plurality of data relating to and/or representative of the defibrillator 2 within a single image.
Advantageously, the barcode 16 and/or the electronic label 17 can act as a marker to activate on the device 10 suitable augmented reality applications configured to superimpose on the screen 15 of the device itself multimedia contents (for example video, audio, 3D objects, etc.) relating to the management of an emergency situation, the use of the defibrillator 2 and/or the methods for carrying out the check and maintenance operations to be carried out on defibrillator 2.
Advantageously, as mentioned, the support element 21 for the barcode 16 and/or the electronic label 17 acts as a security seal and guarantees the integrity of the casing of the defibrillator 2 and/or of the container 19, in which the defibrillator 2 and/or any other components or accessories are housed, so as to certify that the defibrillator and/or the container 19 has not been used and/or tampered with and/or opened.
In particular, the support element 21 for the barcode 16 and/or the electronic label 17 acts as a seal in the sense that it is applied/associated - preferably wrapped around - to the casing of the defibrillator 2 and/or to the container 19, in which said defibrillator and/or any other components are housed, so as not to allow the use of the defibrillator 2 or the access to the inside said container 19, and so that the only way to use/open them is to cause the irreversibly breaking/tampering with of said support element 21 which acts as a seal. Suitably, the support element 21 on which the barcode 16 and/or the electronic label 17 are permanently installed acts as a seal in the sense that it is configured to be applied to the casing of the defibrillator 2 and/or to the housing container 19, so as not to allow to act on said defibrillator or to access inside the container, if not breaking or tampering with said seal.
Suitably, said support element 21 is fixed, mounted and/or applied to the defibrillator 2 casing in a position such as to act as a seal of guarantee and/or safety.
Conveniently, said support element 21 comprises a band 23 which is applied or is wrapped around the defibrillator 2 (i.e. its casing) and/or the container 19 in which said defibrillator 2 is housed. Conveniently, said band 23 can have an annular conformation or be of the belt type (i.e. its ends are intended to be removably joined together).
Conveniently, the barcode 16 and/or an electronic label 17 is applied and/or mounted on said band 23 Preferably, said barcode 16 and/or said electronic label 17 is removably applied on said band 23.
Conveniently, the band 23 can include at least one electronic lock 24. In particular, the electronic lock 24 and/or the band 23 are configured so that:
- when the electronic lock 24 is in the activated closed condition (see fig. 8), the band 23 can be removed from the defibrillator 2, or from the container 19, only by causing the irreversible damage to the band itself,
- when the electronic lock 24 is in the deactivated open condition (see fig. 7), the band 23 can be removed from the defibrillator 2, or from the container 19, without causing irreversible damage to the band itself, so that it can then be re-applied or is wound to defibrillator 2 and/or to container 19.
Conveniently, the passage of the electronic lock 24 from the activated closed condition to the deactivated open condition occurs following a wireless command signal sent from the outside by said device 10, and in particular by the short-range wireless transceiver means of said device 10.
Conveniently, the passage of the electronic lock 24 from the deactivated open condition to the active close condition takes place mechanically in an automatic way (for example by bringing/joining together two ends of the band in which respective components of said lock 24 are mounted) and/or following to a wireless command signal sent from the outside by said device 10, and in particular by the short-range wireless transceiver means of said device 10.
Suitably, the electronic lock 24 is configured so that, each time it passes from the activated close condition to the deactivated open condition, a corresponding electronic circuit - which is integrated and/or connected to said lock - automatically generates a corresponding signal which is transmitted to the device 10 (preferably by means of the short- range wireless transceiver means of the device 10), thus identifying a corresponding event which advantageously is then stored in the device 10 and/or which is transmitted through the communication means 22 of the device 10 to the central remote processing unit 30, to be thus stored in the latter.
In particular, the electronic lock 24 is mounted on the band 23 - for example at two opposite ends of said band 23 - so that, when the lock is in the activated closed condition, it prevents the use of the defibrillator 2, for example preventing access to the defibrillator's graphic interface (display and/or input), or preventing the opening of the defibrillator casing, or even preventing the opening of the container in which the defibrillator 2 is housed. Advantageously, the electronic lock 24 can be provided with an electronic control unit which is associated with short-range wireless reception means, so that the opening/unlocking of the lock 24 is associated with a signal from the short range wireless transceiver means of the device 10. In particular, in this way, the opening of the electronic lock 24 can be caused only by the approach of the device 10. Then, a subject with said portable device 10, who has gone near the defibrillator 2, can unlock the lock 24 (i.e. causing its passage from the activated close condition to the deactivated open condition), and can therefore remove the band 23 without damaging it, in order to check/control the status and operation of the defibrillator 2 or of the other components/accessories housed in the container 19. Suitably, once this check has been completed, it can then reapply the band 23 around the defibrillator and/or the container 19; then, the lock 24 - automatically or following to a further command sent from the outside through/by means of the device 10 - is brought back to the activated close condition.
Advantageously, said band 23 is provided with quick coupling/uncoupling means. Preferably, said quick coupling/uncoupling means are associated with electronic activation means which are controlled by a signal received from the outside (and transmitted by the wireless transceiver means of said device) or by a command that is received from the outside by said electronic label 17. Conveniently, the band 23 can comprise means configured to allow its rapid removal from the defibrillator 2, or from the container 19, however causing irreversible damage to the band itself. In particular, these means allow the band 23 to be quickly removed, making it then no longer reusable. Suitably, these means comprise for example one or more tear points 26 for quickly opening and removing the band 23 that wraps around the defibrillator 2 or the container 19. Suitably, this allows quick access to the defibrillator 2 if its use is required in emergency conditions and, at the same time, constitutes a clear evidence of the fact that it has been used, and that therefore it must then be checked (or recharged) before any subsequent use.
Advantageously, on the band 23 can also be printed (for example by means of a traditional printed tag), or associated by means of an electronic label 17 or a barcode 16, the information which allows the univocal identification of the defibrillator 2 to which the belt 23 is associated. Suitably, the electronic label 17 and/or the barcode 16 can be removable and reusable.
Advantageously, the data contained in the electronic label 17 and/or which are encoded in the barcode 16 can include the serial number, the type and other characteristics or information relating to the defibrillator 2. More in detail, preferably, the data relating to the defibrillator 2 can concern for example the date of construction, the firmware versions, the versions of the software application, the serial number, the purchase date, the product warranty, the expiry date of the batteries and/or electrodes, and/or other data related to the defibrillator and useful for the purpose.
Advantageously, as shown in fig. 3, the defibrillator 2 is associated with, or is incorporated in, a short-range wireless transceiver unit 18 (i.e. in the order of tens of centimeters up to one meter), such as that which uses NFC technology (from the English “Near Field Communication ") or the Bluetooth standard, or a transponder such as RFID (from the English" Radio-Frequency I Dentification "). This short-range transceiver unit is traditional in itself, but it has never been used and/or integrated into a defibrillator for the purposes that are achieved in this specific application.
Correspondingly, therefore, the short range wireless transceiver means of the device 10 are also configured to transmit, receive and/or exchange data with the short range transceiver unit 18 of the defibrillator 2. Therefore, bringing the device 10 closer to the defibrillator 2, the former is capable of acquiring a data packet 20 relating to and/or representative of the defibrillator 2 and sent by the short-range transceiver unit 18 of the latter.
Advantageously, therefore, the short-range wireless transceiver means of the device 10 are configured to query and/or receive both the data contained in the electronic label 17 and the data packet 20 sent by the short-range wireless transceiver unit 18 of the defibrillator 2. Conveniently, the short range wireless transceiver means of the device 10 comprise the same data transceiver module which interfaces both with the electronic label 17 and with the wireless transceiver unit 18 of the defibrillator.
Alternatively, the short-range wireless transceiver means of the device 10 comprise two different data transceiver modules and, in particular, a first module which interfaces with the electronic label 17 (for example by means of the NFC standard) and a different/second module that interfaces with the defibrillator's wireless transceiver unit 18 (for example via the Bluetooth standard). Advantageously, said two transceiver modules are configured for data transmission and/or reception on frequencies or frequency bands which are different between the two modules. Advantageously, said two transceiver modules are configured for data transmission and/or reception with different communication protocols and/or standards. Advantageously, said two transceiver modules are configured for data transmission and/or reception with different communication technologies
The acquisition device 10 is also provided with a processor which is configured to represent on the display 15 of the device itself the data, relating to and/or representative of the defibrillator 2, which have been acquired by means of the acquisition means 12.
In particular, a program is loaded and executed in the processor of the acquisition device 10 to represent on the display 15 the image (photograph) 11 acquired by means of the optical detection means 14.
Conveniently, a suitable program for the reading/decoding of barcode 16 which has been acquired by the device itself through said optical detection means 14 can be loaded and executed inside the processor of the device 10. This reading/decoding program can be also configured to represent the barcode 16 on the display 15 of the device itself (see fig. 2) or, preferably, to represent the data contained in the barcode in an orderly and suitably formatted manner (see fig. 4).
Conveniently, a suitable program can be loaded and executed inside the processor of the device 10 to represent on the display 15 of the device, in a formatted and tidy way, the data contained in the electronic label 17 and acquired by means of the transceiver means of said device 10.
Conveniently, a suitable program can be loaded and executed inside the processor of the device 10 to represent on the display 15 of the device itself, in a formatted and tidy way, the data packet 20 transmitted by the transceiver unit 18 of the defibrillator 2 to the transceiver means of the device 10. For example, the program for processing and representing data, which was acquired by means 12, is a suitable mobile software application (APP) loaded and executed on a smartphone or tablet, even without requiring a connection to the internet (i.e. offline).
Advantageously, the data relating to and/or representative of the defibrillator 2 and acquired by means of the acquisition means 12 of the device 10 are automatically stored locally within a memory unit provided in the device itself.
The device 10 is provided with communication means 22 for sending the image 1 1 and/or the barcode 16 and/or the data contained in the electronic label 17 and/or the data packet 20 (which is sent by the unit 18 of the defibrillator 2) acquired through the transceiver means, to a remote processing unit 30, for example a remote server computer or a cloud data system. In particular, these communication means 22 can use the technology of cellular mobile telephony (with standards such as, for example, according to the GSM, GPRS, LTE, NB-loT standards, etc. or Wmbus, LoRa technologies, etc.) and/or Internet network.
Advantageously, the program for reading/decoding the matrix two-dimensional barcode 16 and/or the data contained in the electronic label 17 and/or the data packet 20 is also loaded and executed inside the remote processing unit 30 sent by the unit 18 of the defibrillator 2. Conveniently, within the remote processing unit 30 a program is loaded and executed to represent on the display 32, associated with the remote processing unit 30, the image 11 and/or the two-dimensional barcode 16 and/or to display, in an orderly and a suitably formatted way, the data contained in the two-dimensional barcode 16 and/or in the electronic label 17 and/or in the data packet 20.
The data relating to and/or representative of defibrillator 2, which were acquired through the means 12 of the device 10 and which were transmitted to the remote unit 30, are automatically stored within the same remote unit. Suitably, this storing is carried out in an organized way in order to facilitate the subsequent interrogation and consultation of the data. Appropriately, the data storage within the remote unit 30 is carried out so that the same data cannot be changed or overwritten, thus guaranteeing their immutability over time. Preferably, this can be done using a shared and immutable data structure of the blockchain type.
Advantageously, the barcode 16 or the data contained in the electronic label 17 or the data packet 20 transmitted by the unit 18 of the defibrillator 2 can also contain an Internet address and, appropriately, the reading program can be configured to automatically send back to the operator, through the internet and suitably with an http or preferably https protocol (i.e. using an encrypted connection for example according to the TLS or SSL cryptographic protocols), to the page of the website corresponding to the above mentioned internet address. Preferably, in this internet page, which is shown on the display of the acquisition device 10 or of the remote processing unit 30, the information contained in the two-dimensional barcode 16 or in the data packet 20 is represented in an orderly and suitably formatted manner.
Advantageously, a software module can be loaded and executed in the processor of the acquisition device 10 or in the remote processing unit 30 which receives the data of the defibrillator 2 acquired by said means 12 and, on the basis of a series of historical data stored and contained, for example, in a database and/or on the basis of any further processing, provides a series of information useful for the operator who, for example, is carrying out check or maintenance operations, such as the type of maintenance operation to be performed on the basis of the history of previous interventions carried out, etc.
Advantageously, the device 10 is provided with a GNSS receiver, preferably GPS but could also be based on other systems (GLONASS, Galileo, IRNSS, BEIDOU, QZSS, etc.). Conveniently, the GNSS receiver is connected to the processor of the device 10 and comprises an antenna for receiving satellite signals and provides, at the output, the current position (i.e. the geographic coordinates in terms of latitude and longitude) of the device 10 on the earth's surface. In particular, when the device 10 is near to the defibrillator 2 in order to acquire the image (photograph) 1 1 and/or the barcode 16 and/or the data contained in the electronic label 17 and/or the data packet 20 that is short-range transmitted by the defibrillator unit 18, the GNSS receiver of the device 10 is suitably activated - preferably automatically - to provide the position (i.e. the geographic coordinates) of the device itself, which therefore substantially corresponds to the one of the defibrillator 2 to which the device 10 necessarily had to approach in order to acquire said data.
Preferably, the GNSS receiver of the device 10 also outputs a representative value of the instant of acquisition (i.e. date and time) of the satellite signals.
The position values (i.e. the geographical coordinates) detected by the device 10 are sent by the latter to a central remote unit where they are conveniently stored and collected in a database provided with means for its consultation and, advantageously, this allows to automatically create a computerized geolocation portal for all defibrillators 2 present in a certain area. Appropriately, the fact that the position values are integrated with the moment of acquisition of the same, allows to provide also information relating to the temporal update of the computerized geolocation portal.
Advantageously, the acquisition device 10 can interface with the geolocation computer portal so that a map 40 of the defibrillators 2 present in a certain area is shown on the display 15 of the device itself.
Advantageously, on the display 15 of the acquisition device 10, they can also be represented in a clear and formatted way information for managing an emergency situation, information on the use of the defibrillator 2, information relating to the methods of carrying out the verification and maintenance operations to be carried out on defibrillator 2. More specifically, in the case of defibrillator 2, the check and maintenance procedures are carried out on the electrodes and on the battery of the same, on the test procedure, on the status of the indicator lights, etc.
Advantageously, a device is also loaded and executed in the device 10 which, based on the history of the data acquired by the means 12 and suitably stored, sends notifications/warnings on the display 15 of the same in order to remind the operator when and what check and maintenance operations are necessary.
Conveniently, a unique identification code is also sent to the remote unit 30 (for example, its IMEI, SDNI or MS ISDN code) relating to the device 10 which performed the acquisition of the data relating to and/or representative of the defibrillator.
Conveniently, the access by the operator to the main screen of the acquisition device 10 is subject to a correct authentication by the operator himself, for example through an introductory screen in which the operator is asked to enter, for example by means of the input means of the user interface with which the device is equipped, a suitable authentication password. Preferably, the authentication and identification of the operator can be carried out by digital electronic signature, by biometric recognition through the means 12 of the device 10 and/or by inserting a pin or by inserting a code sent, for example by text message or a messaging application based on the internet connection, on the device 10. Advantageously, by storing in the device 10 or the remote unit 30, the identification of the operator who acquired the image and/or data, it is built a historical archive of the operators who carried out the check and/or maintenance interventions.
Conveniently, the present invention also relates to the mobile software application (APP) which is configured to implement the above described method and which is loaded and executed in the processor of said portable device 10.
Conveniently, moreover, the present invention also relates to a software application which is configured to implement the above described method and which is loaded and executed in the processor of said central remote processing unit 30.
Conveniently, the present invention also relates to a hardware infrastructure which is configured to implement the above described method.
From what has been said, it appears that the method according to the invention is more advantageous than the traditional ones, since it:
- uses acquisition devices that are already widely available on the market and of affordable cost, - uses acquisition devices that are easily transportable and therefore can reach any area where the equipment is located,
- supports the operator in real time during the verification and maintenance of the equipment,
- allows you to easily acquire information relating to the equipment, as well as any history of the checks and maintenance operations carried out on it,
- reduces the risk of equipment malfunction in an emergency,
- is simple and intuitive to use as most of the steps are carried out automatically,
- regularly reminds the operator to carry out the mandatory procedures to maintain and guarantee the correct operation of the equipment,
- guarantees that the verification and maintenance operations have been carried out correctly since it does not use paper or electronic sheets that could be counterfeited,
- requires the operator to go near the equipment to make one or more acquisitions of an image and/or data, thus certifying that the operator actually went physically near the equipment and that he carried out the check and maintenance operations,
- is focused on the acquisition device, which could potentially be used by different operators at different times;
- is independent of the operator and, advantageously, this allows you to facilitate and speed up the delivery and control steps when an operator is replaced or during shift changes,
- allows to automatically store deadlines, reports, checks, control activities and maintenance on a centralized common portal,
- allows to control and manage the operators responsible for the equipment,
- allows to automatically create and maintain a portal with the position data of all the devices in a certain geographical area.
Furthermore, unlike US2015/1 12704, US2016/058996, US2013/087609,
FR2977961 and WO02/095675, in the solution according to the present invention, it is provided the use of a support element 21 - on which are mounted the barcode 16 and/or the electronic label 17 containing the data relating to and/or representative of the equipment - which is removably applied to the equipment 2 and/or to the container 19, in which said equipment 2 is housed and any other components and/or accessories, and which is configured so as to act as a guarantee and/or security seal of the integrity of the equipment 2 and/or said container 19, so as to certify that said equipment 2 and/or said container 19 are not been tampered with and/or already used and/or opened. This is an advantageous and optimal solution in terms of simplicity of implementation to provide both data relating to and/or representative of the equipment - and in particular relating to its state and operating operation - and a clear evidence relating to the fact that the equipment or its housing container have not been tampered with and/or already used and/or opened.
Furthermore, unlike WO02/095675, the present solution provides for sending the acquired data, and contained in the barcode 16 and/or in the electronic label 17, to a central remote processing unit 30 to be stored inside said unit, thus certifying that a person equipped with a portable device went near said equipment to be checked/verified.
Furthermore, unlike US2015/1 12704, US2016/058996, US2013/087609 and FR2977961 , in the solution according to the present invention it is preferably provided the acquisition of a digital image (photograph) of the equipment to be controlled, thus providing further information relating to the mechanical and structural integrity (and not only operational/functional) of the equipment itself.

Claims

C L A I M S
1. Method for ensuring the correct functionality of an equipment (2), particularly of a medical and/or safety equipment and preferably of a semi-automatic defibrillator, comprising the steps of:
- going physically near said equipment (2) with a portable device (10) which is equipped with its own processor and means (12) for acquiring, near said equipment (2), data relating to and/or representative of the equipment itself,
- activating said means (12) to acquire, near said equipment (2), said data relating to and/or representative of the equipment itself,
- sending the data so acquired, by means of communication means (22) with which said portable device (10) is provided, to a central remote processing unit (30) to be stored inside said unit, thus certifying that a subject with said portable device (10) went near said equipment (2),
and characterized in that said acquisition means (12) of said portable device (10) comprise: - optical detection means (14) for scanning and/or acquiring at least one barcode (16) which contains said data relating to and/or representative of said equipment (2), and/or
- short-range wireless transceiver means for reading the content of at least one electronic label (16) which contains relating to and/or representative data of said equipment (2), and also characterized in that said barcode (16) and/or said electronic label (17) are installed/mounted on a support element (21 ) which is removably applied/associated to the equipment (2) and/or to the container (19), in which said equipment (2) and any other components and/or accessories are housed, said support element (21) being configured so as to act as a seal of guarantee and/or security of the integrity of the equipment (2) and/or of said container (19), so as to certify that said equipment (2) and/or said container (19) have not been tampered with and/or already used and/or opened.
2. Method according to claim 1 , characterized in that said support element (21) for said barcode (16) and/or said electronic label is removably associated/applied:
- to the equipment casing (2) so as not to allow the use or maintenance check of said equipment, and/or
- to said container (19), in which said equipment (2) and any other components and/or accessories are housed, so as not to allow access or maintenance check of what is present inside said container (19).
3. Method according to one or more of the preceding claims, characterized in that the support element (21) is configured so that it can have and pass between two configurations: - a first configuration in which said support element (21 ) can be dissociated/removed from the equipment (2) and/or from said container (19), only by causing irreversible damage to said barcode (16) and/or to said electronic label (17) and/or to the support element itself.
- a second configuration in which it can be dissociated/removed from the equipment (2) and/or from said container (19), without causing the irreversible damage to said barcode
(16) and/or to said electronic label (17) and/or of the support element itself, so that it can then be re-applied/associated to the equipment (2) and/or to the container (19).
4. Method according to the preceding claim, characterized in that said support element (21) is configured so that its passage between said two configurations can be carried out and/or caused only following the correct reception of a wireless command signal sent externally from said device (10), preferably from said short-range wireless transceiver means of said device (10).
5. Method according to one or more of the preceding claims, characterized in that the support element (21) is configured and applied/associated with the equipment (2) and/or its container (19) so that:
- in said first configuration it prevents the use of said equipment (2) and/or the access inside the container (19),
- in said second configuration it allows the use of said equipment (2) and/or the access inside the container (19).
6. Method according to one or more of the preceding claims, characterized in that said support element (21) is configured so as to wrap, at least partially, said equipment (2) and/or said container (19).
7. Method according to one or more of the preceding claims, characterized in that the support element (21) is configured so as to always allow its rapid removal from the equipment (2) or from the container (19), by inevitably and always causing the irreversible damage to the support element itself and/or to the barcode (16) and/or to the electronic label (17) installed on said element.
8. Method according to one or more of the preceding claims, characterized in that the barcode (16) and/or the electronic label (17) are installed on the support element (21) so that to dissociate them from said element support (21) it is caused an irreversible damage to said barcode (16) and/or to said electronic label (17) and/or to the support element itself.
9. Method according to one or more of the preceding claims, characterized in that said support element (21) comprises a band (23) on which said barcode (16) and/or said electronic label (17) are mounted and that it is applied or wrapped around the equipment (2) and/or the container (19) in which said equipment (2) and any other components and/or accessories are housed.
10. Method according to one or more of the preceding claims, characterized in that said band (22) comprises at least one electronic lock (24) and in that said electronic lock (24) and/or said band (23) are configured in such a way that:
- when the electronic lock (24) is in the activated closed condition, the band (22) can be removed from the equipment (2) and/or from its housing (19), only by causing the irreversible damage to the band itself,
- when the electronic lock (24) is in the deactivated open condition, the band (23) can be removed from the equipment (2) and/or or from its housing (19), without causing the irreversible damage to the band itself, so that it can then be re-applied or wound to the equipment (2) and/or to the container (19).
11. Method according to one or more of the preceding claims, characterized in that the passage of the electronic lock (24) from the activated closed condition to the deactivated open condition occurs following a wireless command signal sent from the outside by said device (10), preferably by the short-range wireless transceiver means of said device (10).
12. Method according to one or more of the preceding claims, characterized in that the passage of the electronic lock (24) from the deactivated open condition to the active closed condition occurs mechanically, preferably automatically, and/or following to a command signal wireless sent from the outside by said device (10), preferably by the short-range wireless transceiver means of said device (10).
13. Method according to one or more of the preceding claims, characterized in that the electronic lock (24) is configured so that, each time it passes from the activated closed condition to the deactivated open condition, a corresponding electronic circuit associated with said lock (24) automatically generates a corresponding signal which is transmitted to said device (10), thus identifying a corresponding event to be stored then in the device (10) and/or to be transmitted by means of the communication means (22) of the device (10) to the central remote processing unit (30), to be thus stored in the latter.
14. Method according to one or more of the preceding claims, characterized in that said band (23) comprises means configured to allow rapid removal of the band from the equipment (2) and/or from the container (19) by causing always and inevitably the irreversible damage of the band itself.
15. Method according to one or more of the preceding claims, characterized in that said acquisition means (12) of said portable device (10) comprise optical detection means (14) for acquiring said data relating to and/or representative of said equipment (2) in the form of at least one digital image or photograph (11) of the equipment itself (2).
16. Method according to one or more of the preceding claims, characterized in that said acquisition means (12) of said portable device (10) comprise optical detection means (14) for scanning the barcode (16), thus being able to acquiring said data, coded in said barcode (16), relating to and/or representative of said equipment (2).
17. Method according to one or more of the preceding claims, characterized in that the acquisition means (12) of said portable device (10) comprise short-range wireless transceiver means for interrogating and/or reading the content of said at least one electronic label (17) which contains data relating to and/or representative of the equipment itself.
18. Method according to one or more of the preceding claims, characterized in that said equipment (2) comprises a short-range transceiver unit (18) for sending a data packet (20) relating to and/or representative of the equipment (2) to corresponding short-range reception means of said portable device (10), so as to allow said device (10) to acquire said data relating to and/or representative of the equipment (2).
19. Method according to one or more of the preceding claims, characterized in that the short-range wireless transceiver means of the device (10) is configured to query and/or receive both the data contained in the electronic label (17) installed on the support element (21) and the data packet (20) sent by the short-range wireless transceiver unit (18) of the equipment (2).
20. Method according to one or more of the preceding claims, characterized in that the device (10) is provided with a GNSS receiver and in that, when the device (10) is in the proximity of the equipment (2), the receiver GNSS of the device (10) is activated to provide the current position of the device itself, which substantially corresponds to those of the equipment (2) to which the device (10) necessarily had to approach to acquire the data contained in the barcode (16) and/or in the electronic label (17), installed in the support element (21) associated with the equipment (2) and/or with the container (19), and/or to acquire the data transmitted by the transceiver unit (18) of the equipment itself.
21. Method according to one or more of the preceding claims, characterized in that the position data detected by the GNSS receiver of the device (10) are sent by the latter to the central remote unit where they are suitably stored and collected in a database provided of means for its consultation, in order to define a computerized geolocation portal of the equipments (2) present on a certain territory.
22. Method according to one or more of the preceding claims, characterized in that said barcode (16) and/or said electronic label (17) acts as a marker for activating an augmented reality application on said portable device (10) which is configured to superimpose in real time on the screen (15) of the portable device (10) multimedia contents related to the management of an emergency situation and/or to the use of the equipment (2) and/or to the procedures for carrying out the check and maintenance operations to be performed on the equipment (2).
23. Method according to one or more of the preceding claims, characterized in that it comprises the step of automatically and orderly storing in said portable device (10) the data acquired by said acquisition means (12) of said device (10) and relating to and/or representative of the equipment (2).
24. Method according to the previous claim, characterized in that the data storage within the remote unit (30) is carried out so that the same data cannot be changed or overwritten.
25. Method according to one or more of the preceding claims, characterized in that said portable device (10) is a smartphone and a unique identification code relating to the portable device (10) is also sent to said central remote processing unit (30) which has performed the acquisition of the data relating to and/or representative of said equipment (2), said univocal identification code is the IMEI code of said portable device (10) which carries out the acquisition and/or is the MSISDN code of the phone user associated with said portable device (10).
26. Method according to the preceding claim, characterized in that it is stored in the remote unit (30) the identifier of the portable device (10) which carried out the acquisition of said data relating to and/or representative of the equipment (2) to be checked, thus building a historical archive of the devices that carried out each check and/or maintenance operation on said equipment.
27. Support element (21) to be removably applied to an equipment (2) to be checked and/or to a container (19) in which said equipment (2) and any other components and/or accessories are housed, said support element (21) being of the type suitable for being used in a method according to one or more of the preceding claims.
28. Support element (21 ) according to the preceding claim, characterized in that it comprises a barcode (16) and/or an electronic label (17) containing data relating to and/or representative of the equipment (2) to be checked, said support element (21 ) being configured and associated with said equipment (2) and/or with said container (19) so as to act as a seal of guarantee and/or security of the integrity of the equipment (2) and/or of said container (19), so as to certify that said equipment (2) and/or said container (19) have not been tampered with and/or already used and/or opened.
29. Infrastructure to guarantee the correct functionality of an equipment (2), particularly of a medical and/or safety equipment and preferably of a semi-automatic defibrillator, which is characterized in that it is configured to implement a method according to one or more of the claims from 1 to 26.
30. Infrastructure according to the preceding claim, characterized in that it comprises: - at least a portable device (10) which is equipped with its own processor, means (12) for acquiring, in the proximity of said equipment (2) to be checked/verified, data relating to and/or representative of the equipment itself, and which it is also provided with communication means (22),
- a central remote processing unit (30) in which at least part of the data sent by each portable device (10) by means of said communication means (22) are stored in an organized way, - at least one support element (21), in which said barcode (16) and/or said electronic label
(17) is installed, and which is removably applied to the equipment (2) and/or to the container (19), in which said equipment (2) and any other components and/or accessories are housed, so as to act as a seal of guarantee and/or security of the integrity of the equipment (2) and/or of said container (19), thus certifying that said equipment (2) and/or said container (19) have not been tampered with and/or already used and/or opened.
31. Mobile software application (APP) which is configured to implement a method according to one or more of claims 1 to 26 and which is loaded and executed in the processor of said portable device (10).
PCT/IB2020/053498 2019-04-12 2020-04-14 An improved method for ensuring the correct functionality of an apparatus WO2020208614A1 (en)

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