阅读说明：本技术 Poct仪器及poct系统 (POCT instrument and POCT system ) 是由 D·德尔格兰德 U·波尔施 N·苏特 M·威廉斯 于 2021-03-23 设计创作，主要内容包括：本发明提出一种用于分析生物学样品的即时检验(“POCT”)仪器(1)及包括多个此类POCT仪器(1)的POCT系统(10),其中所述POCT仪器(1)包括壳体(2)；测量单元(3),其经设计用于收集指示生物学样品的至少一个生物学参数的数据；主显示屏(4)；和辅助显示屏(5)。(The present invention proposes a point of care ("POCT") instrument (1) for analyzing a biological sample and a POCT system (10) comprising a plurality of such POCT instruments (1), wherein the POCT instrument (1) comprises a housing (2); a measurement unit (3) designed for collecting data indicative of at least one biological parameter of a biological sample; a main display screen (4); and an auxiliary display screen (5).)

1. Point-of-care "POCT" instrument (1) for analyzing biological samples, comprising

A housing (2);

a measurement unit (3) designed for collecting data indicative of at least one biological parameter of a biological sample;

a main display screen (4);

it is characterized in that the preparation method is characterized in that,

the POCT instrument (1) further comprises an auxiliary display screen (5).

2. POCT apparatus (1) according to the preceding claim, wherein the main display screen (4) and the auxiliary display screen (5) are each integrated into the housing (2) such that the content displayed on each of the main display screen (4) and the auxiliary display screen (5) is visible from outside the housing (2).

3. POCT instrument (1) according to one of the preceding claims, wherein

The main display (4) is arranged on a first side (24) of the housing (2); and is

The auxiliary display (5) is arranged on a second side (25) of the housing (2).

4. POCT apparatus (1) according to one of the preceding claims, wherein the circuitry of the secondary screen (5) is independent of the circuitry of the main display screen (4).

5. POCT instrument (1) according to one of the preceding claims, wherein the POCT instrument (1) comprises a first power supply (84) and a second power supply (85), wherein the POCT instrument (1) is designed such that the main display screen (4) is powered by the first power supply (84) and the auxiliary display screen (5) is powered by the second power supply (85).

6. POCT apparatus (1) according to one of the preceding claims, wherein the average number of pixels per area unit of the main display screen (4) is at least four times larger than the average number of pixels per area unit of the auxiliary display screen (5).

7. POCT instrument (1) according to one of the preceding claims, wherein the housing (2) does not comprise an opening (31) of the measurement unit (3) or only comprises an opening (31) of the measurement unit.

8. POCT apparatus (1) according to one of the preceding claims, wherein the main display screen (4) comprises touch functionality and the auxiliary display screen (5) does not comprise touch functionality.

9. POCT apparatus (1) according to one of the preceding claims, characterized in that the main display screen (4) and the auxiliary display screen (5) are arranged below a common transparent protective layer (7).

10. POCT apparatus (1) according to one of the preceding claims, characterized in that the POCT apparatus (1) comprises a switch unit (6) which is designed to switch off the main display (4) but not the auxiliary display (5).

11. POCT apparatus (1) according to one of the preceding claims, wherein the main display screen (4) is constructed based on a first display technology and the auxiliary display screen (5) is constructed based on a second display technology.

12. POCT apparatus (1) according to the preceding claim, wherein the second display technology consumes less power than the first display technology, e.g. less than half the power per unit of time per unit area.

13. POCT apparatus (1) according to one of the preceding claims, wherein the auxiliary display screen (5) is designed for displaying content without power consumption.

14. POCT apparatus (1) according to one of the preceding claims, wherein the auxiliary display screen (5) requires power for changing the display content, and wherein the POCT apparatus (1) is designed such that commands for changing the content displayed on the auxiliary display screen (5) and the necessary energy for such a change can be sensed from an external source.

15. POCT apparatus (1) according to one of the preceding claims, wherein the auxiliary display screen (5) is designed for displaying constant content.

16. POCT apparatus (1) according to one of the preceding claims, wherein the viewable area of the display screen (4) is at least three times larger than the viewable area of the auxiliary display screen (5).

17. POCT apparatus (1) according to one of the preceding claims, wherein the POCT apparatus (1) is designed for changing the content displayed on the auxiliary display screen (5) in accordance with instructions entered via an external input device.

18. POCT instrument (1) according to one of the preceding claims, wherein

The main display (4) and/or a transparent protective layer (7, 74) arranged on top of the main display (4) is arranged flush with the first side (24) of the housing (2); and is

The auxiliary display (5) and/or a transparent protective layer (7, 75) arranged on top of the auxiliary display (5) is arranged flush with the second side (25) of the housing (2).

19. POCT apparatus (1) according to one of the preceding claims, wherein the main display screen (4) and the auxiliary display screen (5) are arranged on the same side of the housing (2) and do not overlap.

20. POCT instrument (1) according to one of the preceding claims, wherein the POCT instrument (1) comprises an authorization module for selectively authorizing a user of the POCT instrument (1) to use certain functions of the POCT instrument (1).

21. A POCT system (10) includes

A plurality of POCT instruments (1) according to one of the preceding claims;

a system control unit (90), wherein the system control unit (90) is designed for changing the content displayed on the auxiliary display screen (5) of the POCT apparatus (1).

22. POCT system (10) according to the preceding claim, wherein the POCT system (10) is designed for automatically adapting the content displayed on the auxiliary display screen (5) of a POCT instrument (1) of the plurality of POCT instruments (1) to the data stored in the system control unit (90).

23. POCT system (10) according to the preceding claim, wherein the POCT system (10) is designed such that the content displayed on the auxiliary display screen (5) of a POCT instrument (1) of the plurality of POCT instruments (1) is based on data stored in the system control unit (90), and, if the stored data is adjusted in the system control unit (90), the adjusted data is automatically transmitted to the POCT instrument (1) and displayed on the auxiliary display screen (5) based on the content of the adjusted data.

24. POCT system (10) according to one of claims 21 to 23, wherein the POCT instrument (1) is designed for transmitting information relating to a test result to the system control unit (90).

Technical Field

The present invention relates to a point of care testing (hereinafter, referred to as "POCT") instrument and a POCT system including the POCT instrument.

Background

POCT has a major impact on medical decision making, as it can provide critical information to physicians and therefore plays a crucial role in public health care. POCT is primarily performed by nurses or medical staff trained to operate POCT instruments available at patient care sites, such as hospitals, emergency departments, intensive care units, primary care facilities, medical centers, patients 'homes, doctor's offices, pharmacies, or emergency sites.

POCT systems at a site typically include a large number of POCT instruments, and in many cases, the personnel attach adhesive labels on the POCT instruments for organizational purposes, such as indicating the staff or units to which the respective POCT instruments are assigned.

However, it is believed that adhesive labels present hygiene problems, as it may be difficult in practice to avoid dirt accumulation at the adhesive label, especially on the edge and/or adhesive side of the adhesive label in case the adhesive label is partially debonded. Contamination can lead to cross-contamination that can be harmful to individuals and patients, particularly because many locations where POCT instruments are used are especially exposed to pathogens, such as multiple drug resistant pathogens. There is a need to provide POCT instruments that can be kept hygienic in practice with reasonable effort.

Disclosure of Invention

The invention aims to provide a POCT instrument and a POCT system which expand the current technical level. To this end, a POCT instrument and a POCT system according to the independent claims are proposed, and specific embodiments of the invention are set forth in the dependent claims.

A point-of-care testing ("POCT") instrument for analyzing a biological sample is presented, the POCT instrument comprising

A housing;

a measurement unit designed for collecting data indicative of at least one biological parameter of a biological sample;

a main display screen; and

an auxiliary display screen.

According to some embodiments, the primary display is configured based on a first display technology and the secondary display is configured based on a second display technology. According to some specific embodiments, the second display technology consumes less power than the first display technology, e.g., less than half of the power per unit area per unit of time.

According to some embodiments, the auxiliary display screen is designed for displaying content without power consumption.

According to some embodiments, the auxiliary display screen is designed for displaying constant content.

According to some embodiments, the primary display screen is larger than the secondary display screen, for example, wherein the display screen has a viewable area at least three times larger than the viewable area of the secondary display screen.

According to some embodiments, the primary display includes touch functionality and the secondary display does not include touch functionality.

According to some embodiments, the main display and the secondary display are each integrated into the housing such that content displayed on each of the main display and the secondary display is viewable from outside the housing.

In accordance with some embodiments of the present invention,

a main display screen, respectively, i.e. and/or a transparent protective layer arranged on top of the main display screen, arranged flush with the side of the housing; and is

The auxiliary display screen, respectively, i.e. and/or the transparent protective layer arranged on top of the auxiliary display screen, is arranged flush with the same side of the housing.

In accordance with some embodiments of the present invention,

a main display screen is arranged on the first side of the housing; and is

The auxiliary display screen is disposed on the second side of the housing,

wherein the first side and the second side are different.

In accordance with some embodiments of the present invention,

a main display screen, respectively, i.e. and/or a transparent protective layer arranged on top of the main display screen, arranged flush with the first side of the housing; and is

An auxiliary display screen, respectively, i.e. and/or a transparent protective layer arranged on top of the auxiliary display screen, arranged flush with the second side of the housing,

wherein the first side and the second side are different.

According to some embodiments, the main display and the secondary display are arranged below a common transparent protective layer.

According to some embodiments, the main display and the secondary display are arranged on the same side of the housing and do not overlap.

According to some embodiments, the POCT instrument comprises a control unit designed to control the content displayed on the auxiliary display screen.

According to some embodiments, the POCT instrument includes a switch unit designed to turn off the main display but not the auxiliary display.

According to some embodiments, the average number of pixels per area unit of the main display is at least four times larger than the average number of pixels of the auxiliary display.

According to some embodiments, the housing does not comprise an opening of the measurement unit or only an opening of said measurement unit.

According to some embodiments, the circuitry of the secondary display is independent of the circuitry of the primary display.

According to some embodiments, the POCT instrument includes a first power source and a second power source, wherein the POCT instrument is designed such that the primary display screen is powered by the first power source and the secondary display screen is powered by the second power source.

According to some embodiments, the auxiliary display screen requires power for changing the displayed content, and wherein the POCT instrument is designed such that a command for changing the content displayed on the auxiliary display screen and the necessary energy for such a change can be sensed from an external source.

According to some embodiments, the POCT instrument is designed to change the content displayed on the auxiliary display screen according to an instruction input via an external input device.

According to some embodiments, the POCT instrument includes an authorization module for selectively authorizing a user of the POCT instrument to use certain functions of the POCT instrument.

Furthermore, a POCT system is proposed, which comprises

A plurality of POCT instruments according to one of the preceding claims;

a system control unit, wherein the system control unit is designed to change what is displayed on an auxiliary display screen of the POCT instrument.

According to some embodiments, the POCT system is designed to automatically adjust the content displayed on the auxiliary display screen of a POCT instrument of the plurality of POCT instruments to data stored in the system control unit.

According to some embodiments, the POCT system is designed such that the content displayed on the auxiliary display screen of a POCT instrument of the plurality of POCT instruments is based on data stored in the system control unit, and, if the stored data is adjusted in the system control unit, the adjusted data is automatically transmitted to the POCT instrument and displayed on the auxiliary display screen based on the content of the adjusted data.

According to some embodiments, the POCT instrument is designed to transmit information related to the test results to the system control unit.

Drawings

Specific embodiments of the present invention will now be described with reference to the accompanying drawings, which are included to illustrate and not to limit the present invention. In the drawings, there is shown in the drawings,

figure 1 shows a perspective view of a POCT instrument in the form of a portable device,

figure 2 shows a perspective view of another POCT instrument in the form of a portable device,

figure 3 shows a front view of a POCT instrument in the form of a portable device,

figure 4 shows a front view of another POCT instrument in the form of a portable device,

figure 5 shows a schematic diagram of the electronic circuit of the POCT instrument,

figure 6 shows a schematic diagram of the electronic circuitry of another POCT instrument,

figure 7 shows a front view of a POCT instrument in the form of a desktop device,

figure 8 shows a POCT system in which,

FIG. 9 shows a POCT system using Wi-Fi connectivity, and

fig. 10 shows a POCT system using RFID connectivity.

Detailed Description

Fig. 1 shows an example of a proposed POCT instrument 1 in the form of a portable (or handheld) device. The POCT apparatus 1 includes a housing 2, a measurement unit 3, a main display 4, and an auxiliary display 5. The measurement unit 3, the main display 4, and the auxiliary display 5 are each arranged in the housing 2. The main display 4 and the auxiliary display 5 are each visual displays, i.e. designed for displaying visual content. The main display 4 and the auxiliary display 5 are each integrated into the casing 2 so that the content displayed on each of the main display 4 and the auxiliary display 5 can be seen from the outside of the casing 2.

The POCT apparatus 1 including the auxiliary display screen 5 for displaying information is provided, and in other cases, the information is attached using an adhesive label, and the auxiliary display screen displays information to reduce the tendency of attaching an adhesive label having a sanitary problem to the POCT apparatus 1, which in turn can support the "stain resistance" of the POCT apparatus 1, thereby reducing the workload of keeping the POCT apparatus 1 clean and sanitary.

The POCT instrument 1 is designed for analyzing biological samples, e.g. in vitro and/or in vivo. The biological sample analyzed may for example comprise a body fluid (urine, blood, salvia, etc.) and/or be a body part. The measurement unit 3 is designed for collecting data indicative of at least one biological parameter of such a biological sample. Such biological parameters may for example relate to blood coagulation, infectious diseases, blood gases and electrolytes, blood glucose, hemoglobin, cholesterol, cardiac markers, pregnancy, fecal occult blood, urine, food pathogens, drug abuse, A1C, blood pressure, creatinine, liver function, heart rate, pulse parameters and/or body temperature. The measurement unit 3 comprises one or more sensors, such as a camera, a temperature sensor, a gyroscope, an accelerometer and/or electrodes. The measurement unit 3 may, for example, be designed for collecting data of biological material provided on/in a test strip, cassette, tray and/or bud.

The POCT instrument 1 may comprise an evaluation unit (which may for example be part of the control unit 9 as shown in fig. 5) configured for evaluating a quantitative and/or qualitative result related to the at least one biological parameter. According to some embodiments, the POCT instrument 1 is configured to display the results on the main display 4. In one example, the measurement unit 3 includes a camera designed to take a picture of a urine test strip; the evaluation unit is configured for evaluating a value related to the glucose concentration based on the photograph; and the main display 4 is configured to display the value to the user. Additionally or alternatively, the measurement unit 3 may comprise electrodes for measuring the glucose concentration.

The main display 4 and the auxiliary display 5 are each arranged on the surface of the casing 2 so that the contents displayed on the main display 4 and the auxiliary display 5 can be seen from the outside of the casing 2. In the example of fig. 1, the main display 4 and the auxiliary display 5 are each arranged on a common side of the housing 2. However, they may also be arranged on different sides of the housing surface, as shown in fig. 2, wherein the main display 4 is arranged on the first side 24 of the housing 2 and the auxiliary display 5 is arranged on the second side 25 of the housing 2. Arranging the auxiliary display screen 5 on a different side than the main display screen 4 may improve the possibility of being able to directly see the information displayed on the auxiliary display screen 5 when the POCT apparatus 1 is put down and/or improve the possibility of being able to directly see at least one of the two display screens 4, 5.

According to some embodiments, the POCT instrument 1 is an at least almost rectangular parallelepiped hand-held instrument, wherein the main display screen 4 is arranged at a large side of the POCT instrument 1 and the auxiliary display screen 5 is arranged at a small side of the POCT instrument 1. In one example, the POCT instrument 1 is at least an almost flat cuboid, wherein the convex hull of the POCT instrument 1 occupies more than 90% of the volume of the smallest cuboid comprising the POCT instrument 1, wherein the smallest cuboid comprising the POCT instrument 1 is defined by edges having a length a, b and c, wherein a is shorter than b, e.g. less than half the length of b, and b is less than c, e.g. each less than half the length of c, and the large sides of the POCT instrument 1 are the sides associated with edges b and c, and the small sides are the sides associated with edges a and b or a and c. An example of this is shown in figure 2. In actual use, such instruments are usually laid down with one of their large sides so that the small side remains visible, and arranging the auxiliary display screen 5 on such a small side may improve the likelihood that the auxiliary display screen 5 will be visible when the POCT instrument 1 is laid down.

The main display screen 4 may be configured to display data required for normal operation of the POCT instrument 1, such as test results, test information, authorization information, patient trends, dosage information, utility options, and the like. The main display 4 may, for example, be designed for displaying content comprising complex graphics (e.g. icons, images, video sequences, etc.).

The auxiliary display screen 5 may be configured to display and/or assign names and/or indicators (e.g., abbreviations and/or codes) to users, units and/or locations of the respective POCT instrument 1, and/or to log into users of the respective POCT instrument 1. The auxiliary display 5 may, for example, be designed for displaying content comprising letters, numbers and/or punctuation marks; the auxiliary display screen 5 may in particular be configured for displaying ASCII characters. It is conceivable that the auxiliary display 5 is designed to display a simple icon, for example a simple battery icon indicating the charge state of the battery of the POCT instrument 1, for example a battery powering the main display 4 and/or the POCT instrument 1.

According to some embodiments, the auxiliary display screen 5 is configured for displaying system parameters (e.g. operating temperature), network status, connection status, status of consumables (e.g. inserting a test strip into a cavity of the measurement unit 3), quality control status, operating status and/or battery status.

The secondary display 5 may be configured to display information in the event that the primary display 4 is inoperative during an update, due to a software error and/or due to a hardware error; the auxiliary display screen 5 may, for example, be configured to display an indication that the POCT instrument 1 is not operating and/or why the POCT instrument is not operating.

According to some embodiments, the auxiliary display screen 5 is configured for displaying only non-medical information, in particular only information without test results. According to some embodiments, the main display 4 is configured for displaying medical information, in particular for displaying test results.

According to some embodiments, the main display 4 and the secondary display 5 are both electronic visual displays, i.e. the displayed content is changed based on electronic and/or magnetic signals.

According to some embodiments, the main display 4 is constructed based on a first display technology and the auxiliary display 5 is constructed based on a second display technology. According to some specific embodiments, the second display technology consumes less power to display the content than the first display technology, e.g., less than half of the power per unit area per unit of time. In an example, the main display 4 is based on LCD, LED, OLED, QLED and/or plasma technology. The auxiliary display screen 5 may for example be electrophoretic ink based, for example as described in US 5,961,804. For example, the auxiliary display screen 5 may be based on commercially available display technologies under the brand of E Ink JustTint, E Ink Prism, E Ink JustWrite, E Ink's Spectra, or E Ink ACeP (each purchased at 3, 15, 2020). According to some specific embodiments, the auxiliary display screen 5 is designed for displaying content without consuming power, for example, it may use electrophoretic ink technology, for example.

According to some embodiments, the main display 4 is a multi-color display, designed for example to display 255 colors or more (e.g. 32,000 colors or more). The auxiliary display screen 5 may for example be a two-color display screen and/or a display screen designed for displaying only a few colors, for example eight colors or less, and/or a grayscale display screen.

According to some embodiments, both the main display 4 and the secondary display 5 are pixel-based; and the average number of pixels per area unit of the main display 4 is larger than the average number of pixels per area unit of the auxiliary display 5, for example at least four times larger, in particular at least ten times larger.

According to some embodiments, the primary display 4 has a greater resolution than the secondary display 5. For example, the minimum number of pixels in each dimension of the main display 4 may particularly be at least four times as large, particularly at least ten times as large as the maximum number of pixels in each dimension of the main display 4. Lower resolution may reduce production costs and/or reduce power consumption.

According to some embodiments, for example, the main display 4 is larger than the secondary display 5, e.g., the main display 4 has a viewable area that is at least three times larger, e.g., at least six times larger, than the viewable area of the secondary display 5.

According to some embodiments, the main display 4 includes a light source, while the secondary display 5 does not include a light source.

According to some embodiments, the main display 4 includes a touch function that allows a user to make input by touching the main display 4. The touch functionality may be provided by a touch sensor, which may for example be included in an additional layer and/or within the display screen itself. According to some embodiments, the touch function is designed to control what is displayed on the POCT instrument 1, the measurement unit 3 and/or the main display 4 and/or the auxiliary display 5. The use of touch functionality may allow for the elimination of components that are difficult to maintain sanitary (e.g., mechanical keys).

According to some embodiments, the secondary display 5 does not include touch functionality, wherein content displayed on the secondary display 5 may be input via touch functionality of the primary display 4 and/or via external input.

A display screen with fewer color options, with lower pixel density, with a smaller viewing area, without a light source, and/or without touch functionality may have the advantage of less power consumption.

According to some embodiments, the auxiliary display screen 5 is designed for displaying constant content, i.e. displaying the same content for a long time. For example, the auxiliary display screen 5 may be designed to display the same content for weeks, months or even years without the need for a power supply.

According to some embodiments, the main display 4 is accordingly arranged with the transparent protective layer 7 arranged on top of the main display 4 (i.e. on one side on which content may be displayed) flush with the first side 24 of the housing 2; and/or the auxiliary display 5, respectively, the transparent protective layer 7 arranged on top of the auxiliary display 5 is arranged flush with the second side 25 of the housing 2. "flush" herein may refer to having a height difference of 1 mm or less (e.g., 0.3 mm). The first side 24 and the second side 25 may be the same or different. In fig. 1, the transparent protective layer 7 is arranged flush with one side of the housing 2 above the main display 4, and the auxiliary display 5 is arranged flush with the same side of the housing 2. In the example of fig. 2, the transparent protective layer 7 is arranged flush with a first side 24 of the housing 2 above the main display 4 and the auxiliary display 5 is arranged flush with a second side 25 of the housing 2 different from the first side 24. A flush configuration may, for example, have the advantage of being easy to clean. According to some embodiments, the transparent protective layer 7 is made of a stable (robust) material that can withstand detergents and/or disinfectants, such as tempered glass.

According to some embodiments, the housing 2 is made of a stable material capable of withstanding detergents and/or disinfectants, such as Polycarbonate (PC).

According to some embodiments, the POCT instrument 1 comprises a gasket made of thermoplastic elastomer (TPE).

The use of a stabilizing material as a component thereof may have the following advantages: the POCT instrument 1 can be cleaned/sterilized more frequently.

In fig. 3, a first transparent protective layer 7, 74 is arranged on top of the main display 4 and a second transparent protective layer 7, 75 is arranged on top of the auxiliary display 5. In fig. 4, the main display 4 and the auxiliary display 5 are arranged below a common transparent protective layer 7, which has the advantage that fewer transitional edges are needed which present hygiene problems.

According to some embodiments, the main display 4 and the secondary display 5 are arranged on the same side of the housing 2 and do not overlap, as can be seen in fig. 1, 3 and 4, for example. According to some embodiments, the main display 4 and the auxiliary display 5 are arranged at a distance from each other, for example a distance of 5 mm or more (e.g. 20 mm or more). The distance between the display screens may have the following advantages: the contents of the display screen can be easily and independently recognized.

According to some embodiments, the POCT instrument 1 comprises a switching unit 6 (e.g. as shown in fig. 2), wherein the switching unit 6 is designed for switching off the main display 4 and not the auxiliary display 5. "off" may here for example mean that after being turned off no more information is displayed on the main display 4, for example when the display switches to a standby or sleep mode. The switch unit 6 may for example comprise a button, a slider, a touch sensor and/or an electronic switch as shown in fig. 2. The switching unit 6 may for example be designed for starting/stopping the normal operation of the POCT instrument. The proposed switching unit 6 may have the following advantages: the user is allowed to start/stop the normal operation of the POCT apparatus 1 to display contents on the main display 4 separately without interfering with the display of contents on the auxiliary display 5.

According to some embodiments, the POCT instrument 1 is configured for, after not using the POCT instrument 1 (e.g., not receiving an input for a certain period of time (e.g., a predetermined period of time)), for example, turning off the main display 4 and not turning off the auxiliary display 5.

The measurement unit 3 may comprise an opening 31, for example for inserting a biological sample (e.g. a test strip with biological material) into the measurement unit 3. The opening 31 may be an opening to a cavity in which a sensor of the measurement unit 3 is arranged.

As shown in fig. 5, the POCT instrument 1 may comprise electronic components 94 for operating the POCT instrument 1, e.g. for performing measurements and for displaying the measurement results on the main display screen 4. The electronic components 94 may for example comprise a control unit 9 (possibly comprising a processor, volatile memory, non-volatile memory and a bus structure connecting these components) and a power supply 8. The control unit 9 may be controlled, for example, by a user via a touch function of the main display 4. According to some embodiments, the electronic component 94 is also designed to assist in the operation of the display screen 5 (e.g., changing the displayed content).

According to some embodiments, the main display 4 includes a touch sensor 42 for providing touch functionality, as shown in fig. 5. The touch sensor 42 may, for example, be included in an additional layer and/or within the display screen itself.

According to some embodiments, the POCT instrument 1 may use a wired power connection to power/charge the power supply of the POCT instrument, respectively.

According to some embodiments, the POCT instrument 1 comprises a power supply 8, which can be charged wirelessly, e.g. by induction. The wirelessly rechargeable power supply 8 may, for example, be designed to power circuitry to operate the primary display 4, the secondary display 5 and/or the POCT instrument 1. Wirelessly charging the power supply 8 may allow components that are difficult to maintain sanitary (e.g., power outlets) to be eliminated.

According to some embodiments, the POCT instrument 1 comprises a wireless communication unit 91, such as a Wi-Fi module, a digital cellular network (e.g. 2G/3G/4G/5G) module, an RFID module, a bluetooth module and/or an infrared module. The use of wireless communication may allow components that are difficult to maintain sanitary (e.g., communication jacks) to be eliminated.

According to some embodiments, the housing 2 is closed (i.e. without an opening), with the possible exception of the opening 31 of the measuring unit 3. According to some embodiments, the housing comprises exactly one opening, i.e. the opening 31 of the measuring cell 3, or no opening. The openings may become a component that is difficult to maintain sanitary and hygienic, and limiting the number of openings in the housing 2 may allow for an increase in the "cleanability" of the POCT instrument 1.

According to some embodiments, the measurement unit 3 is not detachable from the POCT instrument 1.

According to some embodiments, the measurement unit 3 is mechanically integrated into the POCT instrument 1. In an example, the measurement unit 3 is enclosed by the housing 2 and cannot be removed without disassembling the housing 2, which may include overcoming at least one fastening mechanism (e.g., removing a screw). According to some embodiments, the measurement unit 3 cannot be removed without damaging the housing 2. The mechanical integration may increase the functional safety of the POCT instrument 1, e.g. supporting a precise positioning of the inserted sample with respect to the measurement unit 3.

According to some embodiments, all openings of the housing 2 are designed for inserting a biological sample (a respective carrier carrying the biological sample, e.g. a swab, a test strip, etc.) into the POCT instrument 1. According to some embodiments, the housing 2 comprises exactly one opening and the one opening is designed for inserting the biological sample into the POCT instrument 1.

According to some embodiments, POCT instrument 1 is liquid tight. In one example, POCT instrument 1 includes a closed housing 2 made of Polycarbonate (PC) and an internal gasket made of thermoplastic elastomer (TPE). The POCT instrument 1 may be designed for wireless communication and charging.

According to some embodiments, POCT instrument 1 is liquid-tight except for the opening of measurement cell 3.

The liquid tightness may improve the hygienic properties of the POCT instrument 1, e.g. improve its "cleanability" and/or reduce the risk of cross-contamination.

According to some embodiments, the POCT instrument 1 comprises a control unit 9 designed to control the content displayed on the auxiliary display screen 5. According to some embodiments, the control unit 9 is further designed to control the content displayed on the main display 4. In an example, the control unit 9 is designed for receiving input via a touch function of the main display 4.

According to some embodiments, the measurement unit 3 is electronically integrated into the POCT instrument 1. According to some embodiments, the measurement unit 3 is electronically connected to a control unit 9, which is designed to control the content displayed on the main display 4 via an electronic connection that cannot be detached without damaging the electronic connection. In one example, the measurement unit 3 and the control unit 9 are soldered to the same circuit board. According to some embodiments, the electronic connection includes one or more plug connections, each of which cannot be opened without damaging the plug connection. The electronic integration may improve the functional safety of the POCT instrument 1.

According to some embodiments, the POCT instrument 1 comprises a first power supply 84 and a second power supply 85, as shown in fig. 6, wherein the POCT instrument 1 is designed such that the main display 4 is powered by the first power supply 84 and the auxiliary display 5 is powered by the second power supply 85. According to some specific embodiments, the first power source 84 includes a battery and a coil for inductively charging the battery. Additionally or alternatively, the second power supply 85 comprises a coil for inductively powering the auxiliary display screen 5, e.g. for changing the content displayed thereon.

In the example shown in fig. 6, the auxiliary display 5 does not require power to display content, but requires power to change the displayed content, and a command to change the displayed information and the necessary energy for the change can be induced from an external source via the coil of the second power supply 85, which thus serves as part of the wireless communication unit 91.

As shown in the example of fig. 6, the circuitry of the secondary display 5 may be independent of the circuitry of the main display 4, which may allow information to be displayed on the secondary display 5 in the event that the circuitry of the main display 4 is not operational (e.g., due to a hardware error).

According to some embodiments, the main display 4 comprises a light source 41. According to some embodiments, the secondary display screen 5 does not include a light source. A display screen without a light source may reduce power consumption and may not require power to display content.

Fig. 7 shows an example of the proposed POCT instrument 1 in the form of a table-top device.

Fig. 8 shows a POCT system 10 comprising a plurality of POCT instruments 1, each POCT instrument being for example of one of the types shown in fig. 1 to 4 and 7. Such POCT systems 10 may include tens, hundreds, or even thousands of POCT instruments 1. POCT system 10 further includes a system control unit 90 designed to change what is displayed on an auxiliary display screen 5 of at least one (e.g., any) of POCT instruments 1.

As shown in fig. 8, the POCT system 10 may include a communication network 92 via which the POCT instrument 1 may be connected to the system control unit 90. The communication network 92 may include wireless and/or wired connections. According to some embodiments, the POCT system 10 is designed such that the system control unit 90 can transmit instructions related to content to be displayed on the auxiliary display screen 5 to the POCT instrument 1 including the auxiliary display screen 5 via the communication network 92. In one example, the system control unit 90 transmits to the POCT instrument 1 information that the specific POCT instrument 1 is assigned to a new cell in the hospital, and the POCT instrument 1 (e.g., its control unit) issues an instruction to cause the auxiliary display screen 5 to thereafter display a symbol indicating the new cell.

According to some embodiments, some POCT instruments 1 are desktop devices that can be connected to the system control unit 90 via a wired connection, and some POCT instruments 1 are handheld devices that can be connected to the system control unit 90 via a wireless connection.

According to some embodiments, the system control unit 90 and the POCT instrument 1 each comprise a wireless communication unit 91, for example as part of a communication network. The wireless communication unit 91 may allow the use of wireless signals to change what is displayed on the auxiliary display screen 5 of the POCT apparatus 1. Such a wireless communication unit 91 may for example comprise a Wi-Fi module, a digital cellular network module, an RFID module, a bluetooth module and/or an infrared module. As shown in fig. 9, the system control unit 90 may comprise a centralized unit (e.g., a server and/or a data management system) that may be connected to the POCT instrument 1 from a remote location, for example, using a Wi-Fi network, according to some embodiments. As shown in fig. 10, the system control unit 90 may comprise a portable/handheld device that may be connected to a nearby POCT instrument 1, for example using an RFID connection, according to some embodiments. The portable/handheld device may be designed for inductively transferring power to circuitry connected to the auxiliary display screen 5, e.g. the power required for changing the content displayed on the auxiliary display screen 5.

As can be seen in fig. 8 to 10, the system control unit 90 may be external to the POCT instrument 1, and in particular not included in the housing 2 of the POCT instrument 1. The POCT apparatus 1 may be designed to change the contents displayed on the auxiliary display screen 5 according to an instruction input via an external input device. The instruction may be direct, e.g. including the exact string to be displayed; and/or indirect, e.g., including a numerical code instructing the patient room name to be displayed. The external input device may for example be a keyboard of the system control unit 90, e.g. as shown in fig. 9, or a touch screen of a portable/handheld device of the system control unit 90, as shown in fig. 10. According to some embodiments, the POCT system 10 is designed to wirelessly transmit instructions input via an external input device to the POCT apparatus 1, for example by a shared wireless communication unit 91 of the POCT apparatus 1 connected to the auxiliary display 5 and the main display 4 and/or by a dedicated wireless communication unit 91 of the POCT apparatus 1 connected to the auxiliary display 5 but not connected to the main display 4.

According to some embodiments, the POCT system 10 is designed to automatically adjust the content displayed on the auxiliary display screen 5 of the POCT instrument 1 to the data stored in the system control unit 90. In one example, the system control unit 90 includes a database; the database includes a field for each of the POCT instruments 1 (the field includes, for example, a name assigned to a user of the corresponding POCT instrument 1); the system control unit 90 is designed to automatically transmit, in the event that the content in such a field is changed, the new content of the field to the respective POCT instrument 1; and the POCT instrument 1 is designed to display the transmitted new content on the auxiliary display screen 5. Of course, a single field of the database may also be used for the content displayed on the auxiliary display screen 5 of a plurality of POCT apparatuses 1, for example, all POCT apparatuses 1 in the same ward. Automatically keeping the contents displayed on the auxiliary display screen 5 adjusted to the data stored in the system control unit 90 can simplify the management of the POCT system 10.

According to some embodiments, the POCT system 10 is designed to automatically adjust the content displayed on the auxiliary display screen 5 of the POCT instrument 1 to the data stored in the system control unit 90 in the sense that the content displayed on the auxiliary display screen 5 of the POCT instrument 1 is based on the data stored in the system control unit 90 (e.g., in a predetermined manner), and if the stored data is adjusted in the system control unit 90, the adjusted data is automatically transmitted to the POCT instrument 1 and new content based on the adjusted data (e.g., in the same predetermined manner) is subsequently displayed on the auxiliary display screen 5. In one example, the hospital uses a code to encode the name of its patient room in the database of the system control unit 90, and the POCT instrument 1 is designed to translate the code into the name of the patient room (e.g., by using a corresponding translation table); and, if the corresponding individual code in the system control unit 90 is automatically changed to a new code representing a new patient room, the new code is transmitted to the POCT apparatus 1, translated into the name of the new patient room by the POCT apparatus 1 using the translation table, and then displayed on the auxiliary display screen 5.

According to some embodiments, the POCT system 10 is designed to automatically adapt the content displayed on the auxiliary display screen 5 of the POCT instrument 1 to the data stored in the system control unit 90 in the sense that the content displayed on the auxiliary display screen 5 of the POCT instrument 1 depends on the data string stored in the system control unit 90, and if the data string is adapted in the system control unit 90 (e.g., the character sequence of the data string is changed), the adapted data string is automatically transmitted to the POCT instrument 1 and subsequently displayed on the auxiliary display screen 5 according to the content of the adapted data string. The content may be, for example, the (adapted) data string itself and/or content derived therefrom in a predetermined manner, for example the name of the worker (depending on the code).

According to some embodiments, the POCT system 10 may include a docking station. According to some embodiments, the docking station is designed for charging the power supply 8 of the POCT instrument 1, in particular the handheld POCT instrument 1. The docking station may be designed for wireless charging of the POCT instrument 1, for example using induction. Additionally or alternatively, the docking station may be designed for charging the POCT instrument 1 using a wireless connection, e.g. wherein the docking station and the POCT instrument 1 each comprise a respective connector for transmitting power via the connected connector. The docking station may be designed to accommodate the POCT instrument 1 in a predetermined manner such that when the POCT instrument 1 is accommodated in the docking station in the predetermined manner, the respective connectors are connected, for example wherein parts of the docking station are designed to be opposite to parts of the outer shape of the POCT instrument 1.

According to some embodiments, the docking station is designed for exchanging data with the POCT instrument 1, in particular with the communication unit 91 of the POCT instrument 1. The docking station may be part of the communication network 92 and/or connected to the system control unit 90. According to some embodiments, the docking station is designed for wireless communication with the POCT instrument 1. The docking station may comprise a communication module, for example a Wi-Fi module, a digital cellular network (e.g. 2G/3G/4G/5G) module, an RFID module, a bluetooth module and/or an infrared module, in particular a communication module corresponding to the respective module of the communication unit 91 of the POCT apparatus 1. Additionally or alternatively, the docking station may be designed for wired communication with the POCT instrument 1, e.g. wherein the docking station and the POCT instrument 1 each comprise a respective connector for transmitting data via the connected connector. The docking station may be designed to accommodate the POCT instrument 1 in a predetermined manner such that when the POCT instrument 1 is accommodated in the docking station in the predetermined manner, the respective connectors are connected, for example wherein parts of the docking station are designed to be opposite to portions of the external shape of the POCT instrument. The connector for transmitting data may further be designed for transmitting power, for example, wherein the connector conforms to the USB standard.

According to some embodiments, the POCT system 10 includes a plurality of hand-held POCT instruments 1 and a plurality of docking stations.

According to some embodiments, the POCT instrument 1 comprises an authorization module for selectively authorizing a user of the POCT instrument 1 to use certain functions of the POCT instrument 1, for example to use the measurement unit 3 and/or a specific test routine. In one example, the authorization module is designed to prevent a user from performing certain tests without the necessary credentials that can be used to prove that the user is familiar with those particular tests. The authorization unit may for example be implemented as software executable on the control unit 9. The POCT instrument 1 may include an identification module for identifying a user. The identification module may comprise hardware, such as a reading unit (e.g. a barcode and/or RFID reader) for reading the identification means or an input unit, such as a touch sensor 42 of the main display 4. The authorization module may be designed for selectively authorizing the user using the identification of the user provided by the identification unit. The authorization module may allow for control and/or management of regulatory requirements related to POCT instrument user training.

According to some embodiments, the authorization module comprises a list of users and functions of the POCT instrument 1, and the list specifies which user should be authorized to use which function. The POCT system 10 may be designed to send and/or update the list from the system control unit 90 to the POCT instrument 1.

According to some embodiments, the POCT system 10 is designed such that the authorization module communicates with the system control unit 90 and requests information from the system control unit 90 regarding which functions a particular user should be allowed to use, for example, by sending data regarding the particular user (e.g., data obtained using the identification module) to the system control unit 90. According to an example, the system control unit 90 comprises a respective authorization list and is designed to return to the POCT instrument 1 a set of functions that are allowed to be used by the specific user based on the authorization list.

According to some embodiments, the POCT instrument 1 is designed for transmitting information (e.g. information about test results, information about quality control results, information about training performed on the POCT instrument 1) to the system control unit 90. The transmitted information may allow for the determination of the training level of the user and/or the quality control status of the POCT instrument 1, may allow for the support of audits, and/or may allow for further use of the test results, for example, in a hospital information system and/or by a medical practitioner.

List of reference numerals

1 real-time inspection instrument

10 real-time inspection system

2 casing

24 first side of the housing

25 second side of the housing

3 measuring cell

31 opening

4 main display screen

41 light source

42 touch sensor

5 auxiliary display screen

6 switch unit

7 transparent protective layer

74 transparent protective layer

75 transparent protective layer

8 power supply

84 first power supply

85 second power supply

9 control unit

90 system control unit

91 wireless communication unit

92 communication network

94 electronic assembly