IT202300002124A1 - FLEXIBLE, ELASTIC AND SENSORIZED ADHESIVE DEVICE FOR REMOTE MONITORING OF A PATIENT'S PHYSIOLOGICAL PARAMETERS - Google Patents

Description

Description of the invention entitled:

?FLEXIBLE, ELASTIC AND SENSORIZED ADHESIVE DEVICE FOR REMOTE MONITORING OF A PATIENT'S PHYSIOLOGICAL PARAMETERS?

Description

Field of technique

The present invention finds application in the medical and pharmaceutical sectors. It refers in general to a digital electronic detection system of clinical body parameters for medical use. More specifically, it deals with a flexible, adhesive and conductive sensorized device for medical use, which allows to instantly measure clinical body values.

Known art

As a result of the aging of the population, with the increase in the incidence of chronic degenerative and communicable diseases, there is a growing need, in accordance with the guidelines for the management of specific diseases, for the detection and monitoring of parameters relating to the state of health. Such information can currently be acquired periodically through direct detection by both a health worker and the patient himself.

However, the possibility of acquiring such parameters, although widespread, to be useful from a medical point of view, must be reliable and remains linked to three fundamental variables: 1) it depends on the availability of the instrumentation necessary for the detection; 2) it is linked to the individual ability to acquire the measurement; 3) it is limited to the acquisition time of the measured parameter. Therefore, while some parameters relating to the state of health can be detected in the home context by the health worker or by the patient himself (blood pressure, oxygen saturation in the blood, body temperature), others must necessarily be acquired in a medical environment, outpatient or otherwise, and only by health personnel (Electrocardiogram - cardiac bio-potential, bio-impedance).

The availability of systems for the remote and reliable detection of the parameters being monitored greatly expands (would expand) the possibilities for monitoring the health status of patients who require frequent clinical and instrumental checks to maintain a state of compensation (equilibrium) for diseases subject to worsening.

In recent years, also due to the need for remote management of medical conditions, the field of telemedicine has been introduced and defined. In particular, the National Health System has recently officially included some services that can be provided remotely such as "televisit", "teleconsultation", "teleconsultation" and "teleassistance", through which it is possible to be assisted by remote healthcare personnel. However, even in these circumstances, the recording and monitoring of parameters relating to the state of health of an individual are still tied to the execution of specific additional instrumental tests or direct detection and subject to the limitations described above.

Telemonitoring consists in the remote detection of parameters relating to the health status of an individual in order to promptly correct the management of specific medical conditions or to identify new ones that are not yet clinically evident. It is a method of providing medical services provided in the context of telemedicine that would allow for significant changes in the management of even complex medical conditions. In fact, telemonitoring, when carried out using wearable devices that are not demanding for the monitored subject and therefore do not interfere with the quality of life and the detections carried out, could be used in many healthcare settings, facilitating both the patient's transition from an inpatient to an outpatient environment and signaling the need to increase the intensity of the care to be provided following the worsening of a specific condition.

The remote detection of information relating to the state of health, if carried out using technologically reliable devices that are structurally undemanding for the subject who must use them, will become an essential practice and will be made possible thanks to the technological innovations introduced by telemedicine, allowing for the revolutionization of the clinical management protocols of numerous medical conditions.

There are alternative miniaturized solutions in the known art for the acquisition of instrumental parameters such as cardiac bio-potential, single or double electrode, which however have several evident limitations: 1) they are suitable for measuring cardiac bio-potential with a precision lower than a traditional electrocardiographic recording; 2) they do not allow the acquisition of other parameters, even derived ones, referable to the state of health, leaving unchanged the need to perform traditional instrumental tests that can be performed in a healthcare environment and by healthcare personnel, with all the related inconveniences. Furthermore, given their necessarily small shape, they manage to achieve the objective of practicality of use by the subject who wears them but they are not able to maximize the electric field by measuring the bio-potential through the chest, nor to calculate a pulmonary bio-impedance, which is useful for detecting the respiratory rate and its derived parameters referable to the state of health.

The purpose of this industrial property application is therefore to propose a new and alternative solution to all these limitations of current technology, through an adhesive, flexible and sensorized device for the continuous and remote monitoring of parameters relating to the state of health of a subject, which is able to optimize the extension of the electric field through the chest, achieving a measurement precision and a quantity of detectable physiological parameters much higher than the prior art. The device in question, preferably made of polyamide, is thin, flexible and invisible, and can be comfortably worn, reducing invasiveness to a minimum, without hindering the performance of daily activities. A processing card based on a microprocessor is miniaturized on it and presents, in contact with the skin, a series of electrodes and sensors capable of detecting the physical parameters directly from the body surface of the subject wearing it without the aid of further external instruments; the electrodes and sensors can measure, and the processing card can derive, a plurality of of parameters relating to the state of health such as, by way of non-limiting example: recording of cardiac bio-potential (electrocardiogram), heart rate, blood pressure, oxygen saturation of arterial blood, fluid content of the chest, respiratory rate, body position, body temperature; the data are then sent to a remote display device for evaluation by the doctor.

Description of the invention

The present patent application for industrial invention intends to describe and claim a device equipped with at least one new and alternative solution to the solutions known to date and/or to satisfy one or more needs perceived in the art and in particular deducible from what is reported above. To achieve this purpose, the inventors have developed a flexible, elastic and sensorized adhesive device for the continuous and remote monitoring of the physiological parameters of a patient capable of detecting at least the following physical parameters:

- cardiac bio-potential;

- bio-impedance;

- pace detection;

- body temperature;

- amount of oxygen present in the arterial blood (saturation measurement);

- body position and movement.

The device is composed of electrodes and sensors connected together by a flexible rigid circuit printed preferably on polyamide, a rubbery, soft and twistable plastic polymer, or on silicon paper that has an even greater extensibility, and is characterized by a particular crescent shape that allows it to cross the surface of the human body preferably but not necessarily from the armpit to the heart. The internal layer of the device, the one in contact with the skin, is coated with a special adhesive having specific areas of high electrical conductivity in correspondence with the electrodes, so that the use of a conductive hydrogel is not necessary.

For the purposes of this description, we will refer to one end of the device as the "tail", which is the terminal part in contact with the armpit; to the other end as the "head", which is in contact with the area of the sternum near the heart and houses some sensors and the processing board; and to its median component as the "median segment".

The tail is the terminal part of the flexible circuit in contact with the armpit, it is composed of an external layer preferably in polyamide, an internal adhesive layer having a conductive area, and houses at least:

- a pulse oximeter composed of a LED for photo transmission, at least one photoreceiver LED for receiving the light variation and a lens designed to allow the correct focusing of the beams from the phototransmitter LED to the photoreceiver LED;

- a body temperature sensor;

- an electrode for the detection of cardiac bio-potential and the detection of bio-impedance.

The median segment is placed between the head and the tail, it hosts at least one median electrode suitable for detecting only the cardiac bio-potential, the bio-impedance and is connected to both the head and the tail through the connection that runs along the flexible body of the device; in correspondence with the electrode there is a conductive area of the said adhesive.

The head of the device, in contact with the sternum area near the heart, is composed of an external layer preferably in polyamide which houses at least:

- a processing sheet described below;

- an electrode for the detection of cardiac bio-potential and bio-impedance; and an internal layer, in contact with the skin, consisting of a conductive area of said adhesive. Said adhesive being non-conductive in the areas of adhesion not close to said sensors and electrodes.

The head of the device also comprises a processing board composed of a rigid flexible miniaturized circuit preferably printed on polyamide having at least one microprocessor, a Bluetooth module, a preferably flat circular battery contained inside a special trolley protected from accidental opening, an accelerometer, a GPS position detection system and an antenna; said antenna being specifically developed to be used in proximity to biological tissues without causing absorption or damage, through a particular geometry that allows the radiation lobe to be directed outwards; and said trolley for the battery being able to be pushed outwards by means of two first lateral elements capable of applying a lever when both are pressed simultaneously and having two second non-deformable rubber elements capable of returning the two first elements to their initial position after opening. Optionally, it is possible to also insert an altimeter into the processing board, capable of establishing the altimetric height at which the measurement of physiological parameters is carried out, this information being useful for the clinical evaluation of cardiac health. The functionally characterizing element of the device which is the subject of this industrial patent application is the presence of at least three electrodes capable of measuring the electrical voltage and positioned in three different points of the rib cage, which allows for precise measurement of both the cardiac bio-potential and the bioimpedance: in fact, as regards the bio-potential, the electrodes at the two ends of the device measure the voltage generated by the heart by comparing it with the reference measurement detected by the median electrode; while, in the measurement of the bio-impedance, the two electrodes placed at the two ends (under the armpit and near the sternum) can generate an electrical voltage in response to the injection of a current imposed on the two electrodes and obtain a transverse measurement that maximizes the value of the bio-potential measured in the area where it crosses the lung, so as to also be able to calculate the respiratory rate, the possible presence of liquid in the lung and any sleep apnea.

The presence of electrodes in three points also allows the electrical detection to be calibrated specifically on the artificial bio-potential emitted by a possible pacemaker, with the aim of detecting its presence and any malfunctions. Once correctly positioned on the human body, the device as a whole is therefore able to detect the direct measurement of the cardiac bio-potential, the presence and correct functioning of a pacemaker, the measurements of bioimpedance, body temperature, oxygen level in the arteries, position and movement of the patient's body.

These direct measurements can then be communicated to the processing card located on the head of the device for the determination of further derived clinical parameters. In this way, the device is able to correctly measure a large set of physiological parameters such as, by way of a non-binding example:

- heart rate;

- heart rate variability;

- pressure value;

- pulse oximetry;

- presence of fluid in the lung;

- cardiac output

- respiratory rate;

- body position and movement;

- pedometer;

- body temperature value;

- sleep apnea.

Among the derived parameters, blood pressure is calculated by relating the saturation parameter to the cardiac tracing; the presence of liquid in the lungs is derived from the known values of the electrical resistance of the liquids: the presence of a liquid in the lung in fact increases the detected impedance; the respiratory rate is derived from the variation of the impedance relative to the greater/lesser presence of air in the lung; and sleep apnea emerges from the observation of the respiratory rate, which in the event of arrest simply indicates the temporary absence of breathing.

The presence of the accelerometer provides additional information useful for evaluating the overall clinical picture by showing the patient's position and physical activity, that is, whether he is lying down or standing, whether he is still, walking or running. A particular heart tracing, together with the general clinical picture, can in fact be more or less worrying if the patient is in a state of stillness or motion.

The pulse oximeter and the thermometer, both positioned on the tail of the device, finally accompany all the evaluations by carrying out direct and programmed measurements of body temperature and arterial oxygenation.

Once all the measurements have been taken by the instruments with which the device is equipped, the Bluetooth module on the head and powered by the said battery, sends, through the antenna, all the information to a remote device, such as, for example but not limited to, a mobile phone or a remote computer, which carries out the residual processing and proceeds to the graphic display of all the results through a digital screen. Said remote device being able, in case of exceeding the set clinical parameters, to send an alarm to the user or to the connected doctor.

Said graphic displays of the detected clinical parameters can be sent to a dedicated application for cell phones, thus allowing continuous monitoring by the user or the doctor, and said alarm of exceeding the parametric thresholds can also be received on said application.

In one version of the device, the terminal portion, comprising the median electrode and the tail, can be replaced; in this case, the terminal portion can be connected to the head via a flat miniature male/female socket and replaced with a new terminal portion, for example in the event of a malfunction or for use with a new patient.

According to an embodiment of the invention, the flexible, elastic and sensorized adhesive device for remote monitoring of physiological parameters is also capable of detecting the bio-potential generated by the heartbeat of a fetus, thus allowing its monitoring without having to resort to an ultrasound or a cardiotocograph. In this way, it becomes possible to perform clinical monitoring at the end of pregnancy even from home.

Optionally, the flexible adhesive sensorized device for the detection and display of clinical body parameters is integrated with a doser, i.e. a material that releases a pre-set dose of drug if stimulated by the sensorized device or by the remote display and control system controlled by the physician.

In another version, the adhesive layer that runs along the entire device, placing a conductive area in contact with the electrodes and sensors, is replaceable for use with another patient.

In another version of the device, the head has an on-only button, with switching off only possible via remote application.

In a further version, the external layer on which the sensors and electrodes are printed is made with a silicon paper type support, i.e. silicone printed with conductive ink, capable of ensuring extensibility and adaptability to any complex surface, such as that of the human body.

In a further version, the head of the device includes an "analog front end" sensor designed to separate the wave spectrum and cancel noise due to conducted noise, proximity to other electronic devices and sources of disturbance.

Finally, it should be noted that the device can be made for professional clinical purposes and made available to doctors, but it can also be made in a commercial version specifically designed for athletes, gyms, and anyone who wants to monitor the behavior of their physiological parameters.

The advantages offered by the present invention are evident in light of the description set forth thus far and will be even clearer thanks to the attached figures and the relative detailed description.

Description of the figures

The foregoing advantages, as well as other advantages and features of the present invention, will be illustrated by reference to the attached drawings, which are to be considered purely illustrative and not limiting or binding for the purposes of the present patent application, in which:

- FIGURE 1 shows the upper surface of a possible device 100, where the head 10, the median segment 20 and the tail 30 are visible.

- FIGURE 2 illustrates the lower surface of a possible device 100, the one in contact with the patient's skin, where the electrodes 11, 21 and 31 are visible, the various sensors described, the processing board 12 with some of its components and the connections 110 between the parts.

- FIGURE 3 shows the top layer 200 on which the circuits and sensors are printed, and the bottom layer, composed of the particular adhesive 300 having conductive areas 310 at the electrodes and sensors.

- FIGURE 4 shows the head 10 of the device 100 where the ejection system of a trolley 18 containing the battery 16 and having first ejection elements 18a and second non-deformable rubber elements 18b is visible.

Detailed description of the invention

It will be immediately obvious that countless variations and modifications can be made to what has been described (for example, relating to shape, dimensions, arrangements and parts with equivalent functionality) without departing from the scope of protection of the invention as it appears in the appended claims.

With reference to Figures 1 and 2, a possible embodiment of the device 100 is shown, consisting of a lower adhesive layer 300 having high conductivity areas 310 in correspondence with the electrodes and sensors described below; and an upper layer of plastic polymer 200, preferably polyamide, having a thickness of 0.14 mm and comprising:

- a head 10, comprising a processing board 12, at least one electrode 11 and an accelerometer 13. Said processing board 12 comprising in turn at least one microprocessor 14, a Bluetooth device 15, a battery 16 preferably of the 3V flat type capable of powering the device for an indicative period of 40 days and inserted inside a trolley 18 protected from accidental opening, a GPS position detection system, a special antenna 17 optimised for outward radiation and a button 19 for switching on; said button 19 being inhibited from the switch-off function, possible only from a remote device;

- a median segment 20, comprising at least one electrode 21;

- a tail 30, comprising at least one electrode 31, a pulse oximeter 32 and a temperature sensor 33;

- said head 10, median segment 20 and tail 30 being connected to each other by at least one electrical connection 110.

The said tail 30 being intended to adhere, by means of the special adhesive 300, under the armpit of the patient; the said head 10 being intended to adhere, by means of the same adhesive 300, on the sternum near the heart; and the said median portion 20 adhering in an intermediate position on the chest of the patient wearing the device 100.

The two said electrodes 11 and 31 being suitable for measuring the cardiac bio-potential by means of a reference value provided by the said electrode 21, positioned in contact with the patient's body in a median position; the two said electrodes 11 and 31 being also suitable for measuring the pulmonary bio-impedance by being able to generate an electrical voltage and obtain a transverse measurement that maximizes the bio-impedance measured through the thorax, so as to also be able to calculate the respiratory rate, the possible presence of liquid in the lung and any sleep apnea. The said accelerometer 13 being suitable for detecting the position and movement of the patient's body; the said pulse oximeter 32 being suitable for detecting the quantity of oxygen present in the arteries; the said temperature sensor 33 being suitable for detecting the body temperature.

The said Bluetooth device 15 being capable of transmitting the physiological parameters detected directly on the patient's body to a remote device capable of processing the additional physiological parameters derived such as, by way of non-binding example:

- heart rate;

- heart rate variability;

- pressure value;

- pulse oximetry;

- presence of fluid in the lung;

- cardiac output;

- respiratory rate;

- body position and movement;

- pedometer;

- body temperature value;

- sleep apnea.

This information is aggregated and appropriately graphed and finally displayed on a remote device, such as, for example, a mobile phone and/or a computer and/or a tablet, equipped with dedicated software; said remote device can then send a visual and/or audible alarm when the detected parameters exceed certain preset thresholds or in all cases in which the doctor or the supervising user have set the need to receive an alarm based on the variation of the detected physiological data.

It is clear that modifications, additions or variations obvious to a person skilled in the art may be made to the invention described herein without thereby departing from the scope of protection provided by the attached claims.

Claims (20)

Claims 1. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters comprising a lower adhesive layer (300) having highly conductive areas (310) and an upper layer made of plastic polymer (200), characterised in that it comprises: - a functionally distinct head (10), comprising: a processing board (12), at least one electrode (11) and an accelerometer (13); said processing board (12) comprising in turn at least one microprocessor (14), a Bluetooth device (15), a GPS position detection device, a battery (16) preferably a button battery, an antenna (17) and an on/off button (19) inhibited by the off function; - a functionally distinct median segment (20), comprising at least one electrode (21); - a functionally distinct tail (30), comprising at least one electrode (31), a pulse oximeter (32) and a temperature sensor (33); said head (10), median segment (20) and tail (30) being connected to each other by at least one electrical connection (110); said tail (30) being able to adhere, by means of the special adhesive (300), under the patient's armpit; said head (10) being able to adhere, by means of the same adhesive (300), on the sternum near the heart; and said median portion (20) adhering in an intermediate position on the chest of the patient wearing the device (100). 2. Flexible, elastic and sensorized adhesive device for the remote monitoring of a patient's physiological parameters, according to the previous claim, characterized in that the two said electrodes (11 and 31), positioned respectively on the sternum near the heart and under the armpit, are suitable for measuring the cardiac bio-potential with the aid of a reference value provided by the said electrode (21), positioned in contact with the patient's body in a median position. 3. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, according to the previous claim, characterized in that said measurement regarding the cardiac biopotential is conveyed through said Bluetooth module (15) present on said processing board (12), to a remote processing device on which it is used to derive at least the value of the heart rate, the heart rate variability and the possible presence and correct functioning of a possible cardiac electro-stimulator present in the patient's body; the heart rate being a direct function of the bio-potential and its variation; the presence and functioning of a pacemaker being detectable through the listening calibration of the artificial bio-potential specifically emitted by the pacemaker. 4. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized in that the two said electrodes (11 and 31), positioned respectively on the sternum near the heart and under the armpit, are suitable for measuring bio-impedance, generating an electrical voltage and obtaining a transverse measurement that maximizes the bio-impedance parameter in the lung crossing area. 5. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, according to the previous claim, characterized in that said measurement regarding bio-impedance is conveyed through said Bluetooth module (15) present on said processing board (12), to a remote processing device on which it is used to derive at least the value of the respiratory rate, the possible presence of liquid in the lung and any sleep apneas; the respiratory rate being derived from the value of the impedance which varies as the air in the lung varies; the presence of liquid in the lung being derived from the variation of the impedance which varies as a function of the presence of a liquid; sleep apneas being a function of the temporary cessation of the respiratory rate. 6. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, at least according to claims 1, 2 and 3, characterized in that the detection of the measurement of oxygen in the arterial blood carried out by said pulse oximeter (32) is used in combination with the heart rate trace obtained according to claims 2 and 3, to derive the value of the current blood pressure; said derivation being calculated on said remote device following the reception of the direct measurements obtained by means of said Bluetooth device (15). 7. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized by measuring the patient's body position and state of motion by means of said accelerometer (13); said measurement indicating whether the patient is lying down or standing, whether he is walking and how many steps he is taking, whether he is running, whether he is under stress, in what position he is sleeping and more; said information being interfaceable with the data relating to the cardiac trace and other available direct and derived parameters. 8. Flexible, elastic and sensorized adhesive device for remote monitoring of the physiological parameters of a patient, according to any of the preceding claims, characterized by measuring the current body temperature of the patient by means of said temperature sensor (33); said information being useful when integrated into the evaluation of all available direct and derived parameters. 9. Flexible, elastic and sensorized adhesive device for the remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized in that said antenna (17) present on said processing board (12) is equipped with a geometry configured to direct the radiation lobe outwards, avoiding absorption or damage to biological tissues. 10. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized in that said battery (16) present in the head (10) of the device is inserted inside a specific trolley (18) protected from accidental opening; said trolley (18) can be pushed outwards by means of two first lateral elements (18a) capable of applying a lever when both are pressed simultaneously and having two second non-deformable rubber elements (18b) capable of returning the two first elements to their initial position after opening. 11. Flexible, elastic and sensorized adhesive device for the remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized in that it comprises an altimeter, positioned in said processing board (12) and capable of establishing the altimetric height at which the measurement of the physiological parameters is carried out, such information being useful for the clinical evaluation of cardiac health. 12. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized in that the terminal portion of said device (100), comprising the median segment (20) and the tail (30), is entirely replaceable with a new equivalent one; said portion being easily connectable/disconnectable from the head (10) through a miniaturized socket suitable for continuing said electrical connection (110); said device (100) being thus replaceable in the event of malfunctions and reusable on different patients. 13. Flexible, elastic and sensorized adhesive device for the remote monitoring of the physiological parameters of a patient, according to any of the preceding claims, characterized by the fact of detecting the biopotential generated by the heartbeat of a fetus, thus allowing the clinical monitoring of a pregnancy. 14. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized in that it comprises a material or a dispenser capable of releasing a pre-established dose of drug when stimulated by the sensorized device or by a remote display and control system controlled by the doctor. 15. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized in that the adhesive (300) having conductive areas (310) in correspondence with electrodes and sensors, is entirely removable and replaceable with a new dedicated equivalent adhesive, thus making the device (100) reusable on a new patient. 16. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized in that the external layer (200) on which the sensors and electrodes are printed is made of flexible polyamide, so as to guarantee greater adaptability to the human body. 17. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized in that the external layer (200) on which the sensors are printed is made with a silicon paper type support, i.e. silicone printed with conductive ink, capable of ensuring extensibility and adaptability to any complex surface, such as that of the human body. 18. Flexible, elastic and sensorized adhesive device for the remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized by integrating an "analog front end" type sensor on said processing board (12), said sensor being capable of separating the wave spectrum and cancelling noise due to conducted noise, proximity to other electronic devices and sources of disturbance. 19. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized in that it is suitable for monitoring sports performance. 20. Flexible, elastic and sensorized adhesive device for remote monitoring of a patient's physiological parameters, according to any of the preceding claims, characterized in that all the measurements directly detected by the electrodes and sensors on the patient's body are sent, by means of said Bluetooth device (15), to said remote processing device, such as, for example, a mobile phone, a tablet or a computer, which remote device, by means of dedicated software, displays them graphically on a digital screen; said remote processing device being capable of displaying at least the following overall physiological parameters: - heart rate; - heart rate variability; - pressure value; - pulse oximetry; - presence of fluid in the lung; - respiratory rate; - body position and movement; - pedometer; - body temperature value; - sleep apnea; said remote processing device having a switch-off command for said device (100); said remote processing device being able to be configured by the user to send visual, audible and other alarms to the attention of the user himself or of the attending physician, in the event that one or more detected physiological parameters exceed the set reference values.