TW202229851A - Modified test strip structure - Google Patents

Modified test strip structure Download PDF

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TW202229851A
TW202229851A TW110101823A TW110101823A TW202229851A TW 202229851 A TW202229851 A TW 202229851A TW 110101823 A TW110101823 A TW 110101823A TW 110101823 A TW110101823 A TW 110101823A TW 202229851 A TW202229851 A TW 202229851A
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test piece
unit
power supply
processing unit
power
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TW110101823A
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Chinese (zh)
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TWI792156B (en
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鍾協訓
謝秉羲
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超極生技股份有限公司
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Abstract

The present invention provides a modified test strip structure, which includes a strip main body and a bumper. The strip main body has a detection area for contact with a sample to be tested and a circuit area that is not for contact with the sample to be tested. The detection area has a detection circuit electrically connected to the circuit area. The detection circuit is adapted for electrochemical reaction with the sample to be tested. The strip main body has a first end, a second end opposite to the first end, an upper surface and a lower surface. The detection circuit is disposed on the upper surface of the first end. The bumper is disposed on the lower surface of the strip main body so as to make the first end of the strip main body higher than the second end thereof when the modified test strip structure is placed on a desktop, thereby reducing the problem of sample contamination on the desktop during sampling.

Description

試片改良結構Test piece improved structure

本發明是關於一種電化學感測技術,特別是關於一種試片改良結構。The present invention relates to an electrochemical sensing technology, in particular to an improved structure of a test piece.

電化學感測器(Electrochemical Sensor)已被成熟應用於各種流體的檢測上,許多電化學感測器搭配檢測試片一起使用,這些試片用以接觸待檢測樣本。出於小型化、方便使用的目的,大部分試片的結構是扁平薄片狀的,其厚度很小,因此電化學檢測區與桌面之間的垂直距離短。在部分使用場合中,現有的試片結構容易造成試樣污染桌面,例如,在血糖檢測的使用場合中,使用者利用採血針對指頭採血後,在指腹接觸試片的過程中,血液容易不慎塗抹到桌面上而造成污染。Electrochemical sensors have been maturely used in the detection of various fluids. Many electrochemical sensors are used together with test strips, which are used to contact the samples to be detected. For the purpose of miniaturization and convenient use, most of the test pieces are in the form of flat sheets with very small thickness, so the vertical distance between the electrochemical detection area and the table top is short. In some applications, the existing test strip structure is likely to cause the sample to contaminate the desktop. For example, in the application of blood sugar testing, after the user uses the blood collection needle to collect blood from the finger, the blood is easily in the process of contacting the test strip with the finger pulp. Be careful to smear on the table and cause pollution.

本發明之主要目的在於提供一種提供一種能減少試樣污染桌面問題發生的試片。The main purpose of the present invention is to provide a test piece that can reduce the problem of sample contamination on the table.

為了達成上述及其他目的,本發明提供一種試片改良結構,其包括一試片本體及一墊高件,試片本體具有一供與待檢測試樣接觸的檢測區及一不供與待檢測試樣接觸的電路區,檢測區具有檢測電路,檢測電路與電路區電性連接,且檢測電路是供與待檢測試樣進行電化學反應;其中,試片本體具有一第一端、一相反於第一端的第二端、一上表面及一下表面,檢測電路位於第一端的上表面;墊高件設於試片本體的下表面,用以在試片改良結構平放於一桌面時讓試片本體的第一端高於第二端。In order to achieve the above and other objects, the present invention provides an improved structure of a test piece, which includes a test piece body and a spacer. The circuit area in contact with the sample, the detection area has a detection circuit, the detection circuit is electrically connected with the circuit area, and the detection circuit is used for electrochemical reaction with the sample to be detected; wherein, the test piece body has a first end, an opposite On the second end, an upper surface and a lower surface of the first end, the detection circuit is located on the upper surface of the first end; the booster is arranged on the lower surface of the test piece body, and is used to lay the test piece on a table in the improved structure Make the first end of the test piece body higher than the second end.

本發明通過額外設置一墊高件讓試片本體的第一、二端形成高低差,並讓試片本體第一端翹起,從而避免或至少大幅減少試樣施加至位於第一端的檢測電路時不慎污染桌面的情形。In the present invention, a height difference is formed between the first and second ends of the test piece body, and the first end of the test piece body is tilted, thereby avoiding or at least greatly reducing the detection of the sample applied to the first end. Accidental contamination of the desktop during the circuit.

請參考第1至5圖,所繪示者為本發明試片改良結構的第一實施例,其中,試片改良結構可用於各種流體的檢測,用以檢測待檢測試樣中是否含有目標分析物、目標分析物的濃度及/或其他所需檢測的數值,所述待檢測試樣可為但不限於血液、尿液、水體樣本或其他非水的流體樣本,所述目標分析物可為但不限於糖化血紅素、血糖、重金屬、硝酸鹽、亞硝酸鹽、過敏原、甲醛、溶氧等化合物,所述需檢測的數值可為但不限於酸鹼值、導電度等物理參數。在可能的實施方式中,試片改良結構可與一檢測儀搭配使用,進行檢測時,試片改良結構可插入檢測儀或以其他方式形成機械性連接,由檢測儀發出檢測信號進行檢測。在其他可能的實施方式中,試片改良結構可與一未與該試片改良結構機械性連接的接收元搭配使用,所述機械性連接係指兩元件實體上的直接接觸,所述接收元可為但不限於手機、平板電腦、電腦或其他可與試片改良結構形成無線連接並可顯示、處理及/或中繼傳輸檢測參數訊號的設備。Please refer to Figures 1 to 5, which are the first embodiment of the improved structure of the test strip of the present invention, wherein the improved structure of the test strip can be used for the detection of various fluids to detect whether the sample to be tested contains the target analysis The concentration of analyte, target analyte and/or other values required to be detected, the sample to be detected can be but not limited to blood, urine, water samples or other non-aqueous fluid samples, the target analyte can be But not limited to compounds such as glycosylated hemoglobin, blood sugar, heavy metals, nitrates, nitrites, allergens, formaldehyde, dissolved oxygen, etc. The values to be detected may be, but are not limited to, physical parameters such as pH, conductivity, etc. In a possible implementation, the improved test piece structure can be used in conjunction with a detector. During detection, the improved test piece structure can be inserted into the detector or mechanically connected in other ways, and the detector can send a detection signal for detection. In other possible embodiments, the test strip modification structure can be used with a receiving element that is not mechanically connected to the test strip modification structure. It can be, but not limited to, a mobile phone, a tablet computer, a computer or other devices that can form a wireless connection with the improved structure of the test piece and can display, process and/or relay and transmit detection parameter signals.

試片改良結構包括一試片本體10、一電源激活手段及一墊高件50,試片本體10具有一供與待檢測試樣接觸的檢測區11、一不供與待檢測試樣接觸的電路區12、一電化學處理單元13、一無線傳輸單元14、一電源單元15、一基板16、一組裝電路板17、一收縮膜20及一保護殼30;除此之外,試片本體10還具有一第一端101、一相反於第一端101的第二端102、一上表面103及一下表面104。The improved structure of the test piece includes a test piece body 10, a power activation means and a booster 50. The test piece body 10 has a detection area 11 for contact with the sample to be tested, and a detection area 11 not for contact with the sample to be tested. Circuit area 12, an electrochemical processing unit 13, a wireless transmission unit 14, a power supply unit 15, a substrate 16, an assembled circuit board 17, a shrink film 20 and a protective shell 30; in addition, the test piece body 10 also has a first end 101 , a second end 102 opposite to the first end 101 , an upper surface 103 and a lower surface 104 .

檢測區11具有一位於第一端101上表面103的檢測電路111,檢測電路111與電路區12電性連接而供與所述待檢測試樣進行電化學反應;視目標分析物或需檢測的數值,檢測電路111可能包括但不限於工作電極、參考電極、輔助電極及/或檢測電極;並且,視目標分析物或需檢測的數值,至少一部分檢測電路111還可能包括但不限於附著在導電體上、有助於檢測目標分析物或需檢測的數值的化學試劑、酶、觸媒及/或酵素。The detection area 11 has a detection circuit 111 located on the upper surface 103 of the first end 101. The detection circuit 111 is electrically connected to the circuit area 12 for electrochemical reaction with the sample to be detected; The detection circuit 111 may include, but is not limited to, a working electrode, a reference electrode, an auxiliary electrode and/or a detection electrode; and, depending on the target analyte or the value to be detected, at least a part of the detection circuit 111 may also include, but is not limited to, a conductive On-body chemical reagents, enzymes, catalysts and/or enzymes that aid in the detection of a target analyte or value to be detected.

電化學處理單元13、無線傳輸單元14及電源單元15設於電路區12且被收縮膜20包覆,保護殼30則包覆收縮膜20,但保護殼30不直接接觸電化學處理單元13、無線傳輸單元14及電源單元15而避免形成沾黏。電化學處理單元13例如可為但不限於微型處理器,無線傳輸單元14可為但不限於藍芽傳輸晶片,電源單元15可為電容器、燃料電池或其他可充電或不可充電的微型電池,用以供給電力給電化學處理單元13及無線傳輸單元14。The electrochemical processing unit 13 , the wireless transmission unit 14 and the power supply unit 15 are arranged in the circuit area 12 and covered by the shrink film 20 , and the protective case 30 covers the shrink film 20 , but the protective case 30 does not directly contact the electrochemical processing units 13 , The wireless transmission unit 14 and the power supply unit 15 avoid sticking. The electrochemical processing unit 13 may be, for example, but not limited to, a microprocessor, the wireless transmission unit 14 may be, but not limited to, a bluetooth transmission chip, and the power supply unit 15 may be a capacitor, a fuel cell, or other rechargeable or non-rechargeable miniature batteries. To supply power to the electrochemical processing unit 13 and the wireless transmission unit 14 .

其中,檢測區11及檢測電路111設於基板16,電化學處理單元13、無線傳輸單元14、電源單元15及電路區12則設於組裝電路板17(PCB Assembly),亦即,本發明的組裝電路板17在與基板16疊合之前,其上即已完成電路區12的設置及電化學處理單元13、無線傳輸單元14與電源單元15的組裝,且當組裝電路板17與基板16疊合後,檢測電路111可與電路區12形成電性連接,例如,組裝電路板17與基板16之間可設有相對應的接腳/焊墊,或可通過導電膏輔助形成電性連接。為了縮小試片本體10的體積,可在基板16上預先開設至少一個可容置電化學處理單元13、無線傳輸單元14及電源單元15的鏤空區161,從而當組裝電路板17與基板16疊合後,電化學處理單元13、無線傳輸單元14及電源單元15可埋入基板16。Among them, the detection area 11 and the detection circuit 111 are arranged on the substrate 16, and the electrochemical processing unit 13, the wireless transmission unit 14, the power supply unit 15 and the circuit area 12 are arranged on the assembly circuit board 17 (PCB Assembly). Before the assembled circuit board 17 is stacked with the substrate 16 , the setting of the circuit area 12 and the assembly of the electrochemical processing unit 13 , the wireless transmission unit 14 and the power supply unit 15 have been completed, and when the assembled circuit board 17 is stacked with the substrate 16 After being assembled, the detection circuit 111 can be electrically connected to the circuit area 12. For example, corresponding pins/pads can be provided between the assembled circuit board 17 and the substrate 16, or the electrical connection can be assisted by conductive paste. In order to reduce the volume of the test piece body 10 , at least one hollow area 161 for accommodating the electrochemical processing unit 13 , the wireless transmission unit 14 and the power supply unit 15 can be pre-established on the substrate 16 , so that when the circuit board 17 and the substrate 16 are stacked on the assembled circuit board 16 After being combined, the electrochemical processing unit 13 , the wireless transmission unit 14 and the power supply unit 15 can be embedded in the substrate 16 .

電源激活手段用以供使用者選擇性激活電源單元15向電化學處理單元13及無線傳輸單元14供給電力的能力,亦即,電源單元15的供電能力被激活時,電源單元15才能供給電力給電化學處理單元13及無線傳輸單元14;反之,電源單元15的供電能力未被激活時,電源單元15無法供給電力給電化學處理單元13及無線傳輸單元14,藉以保留電力。電源激活手段例如為可遮斷電源單元15與其他電路的電源遮斷膜40,此時試片本體10更包括一與電路區12電性連接的簧片18,電源遮斷膜40可移動地設於基板16及組裝電路板17之間且可自一遮斷位置被抽離;當電源遮斷膜40位於遮斷位置時,電源遮斷膜40間隔於簧片18與電源單元15之間而使電源單元15無法向電化學處理單元13及無線傳輸單元14供給電力;當電源遮斷膜40自遮斷位置被抽離時,簧片18與電源單元15即不再被遮斷而可形成電性連接,從而使電源單元15向電化學處理單元13及無線傳輸單元14供給電力的能力被激活,在此同時,電化學處理單元13也被喚醒,而可開始執行試樣的檢測。需說明的是,在其他可能的實施方式中,電源激活手段也可改為但不限於開關、旋鈕;在其他可能的實施方式中,電源激活手段為將電源單元置入試片本體的動作。The power activation means is used for the user to selectively activate the power supply capability of the power supply unit 15 to supply power to the electrochemical processing unit 13 and the wireless transmission unit 14 , that is, the power supply unit 15 can only supply power when the power supply capability of the power supply unit 15 is activated. The chemical processing unit 13 and the wireless transmission unit 14; on the contrary, when the power supply capability of the power supply unit 15 is not activated, the power supply unit 15 cannot supply power to the electrochemical processing unit 13 and the wireless transmission unit 14, so as to retain the power. The power activation means is, for example, a power blocking film 40 that can block the power supply unit 15 and other circuits. At this time, the test strip body 10 further includes a reed 18 that is electrically connected to the circuit area 12. The power blocking film 40 is movably It is disposed between the substrate 16 and the assembled circuit board 17 and can be pulled away from a blocking position; when the power blocking film 40 is located at the blocking position, the power blocking film 40 is spaced between the spring 18 and the power supply unit 15 Therefore, the power supply unit 15 cannot supply power to the electrochemical processing unit 13 and the wireless transmission unit 14; when the power blocking film 40 is pulled away from the blocking position, the reed 18 and the power supply unit 15 are no longer blocked and can be An electrical connection is formed so that the power supply unit 15 can activate the ability to supply power to the electrochemical processing unit 13 and the wireless transmission unit 14, and at the same time, the electrochemical processing unit 13 is also awakened, and the detection of the sample can be started. It should be noted that, in other possible implementations, the power activation means can also be changed to but not limited to switches and knobs; in other possible implementations, the power activation means is an action of placing the power supply unit into the test strip body.

墊高件50設於試片本體10的下表面104,用以在試片改良結構平放於桌面時,讓試片本體10的第一端101高於第二端102,例如,當平放於桌面時,第一端可較該第二端高至少1 mm,例如3-5 mm,從而避免或至少大幅減少採樣時試樣污染桌面的情形;在本實施例中,墊高件50僅設置於試片本體10的局部下表面並鄰近第一端101,並且可與保護殼30一體成形,但墊高件50的設置位置及方式並不以此為限,例如在第6圖所示的第二實施例中,墊高件50設置於保護殼30的完整下表面,且兩者可以貼合或其他方式加以連接。The booster 50 is disposed on the lower surface 104 of the test piece body 10 to make the first end 101 of the test piece body 10 higher than the second end 102 when the improved structure of the test piece is laid flat on the desktop. When used on a desktop, the first end can be at least 1 mm higher than the second end, such as 3-5 mm, so as to avoid or at least greatly reduce the situation that the sample contaminates the desktop during sampling; It is arranged on a partial lower surface of the test piece body 10 and is adjacent to the first end 101, and can be integrally formed with the protective shell 30, but the arrangement position and method of the booster 50 are not limited to this, for example, as shown in FIG. 6 In the second embodiment of the present invention, the booster 50 is disposed on the entire lower surface of the protective shell 30, and the two can be attached or connected in other ways.

在一種僅作為例示、非限定的實施方式中,前述試片改良結構可應用於一電化學感測方法,該方法依序包括下列步驟: 利用電源激活手段激活電源單元15向電化學處理單元13及無線傳輸單元14供給電力的能力,藉此喚醒電化學處理單元13及無線傳輸單元14; 利用電化學處理單元13對檢測電路111發出用於執行檢測的控制訊號; 在檢測電路111收到控制訊號後,利用檢測電路111與待檢測試樣進行電化學反應並向電化學處理單元13回授一反餽訊號; 利用電化學處理單元13將反餽訊號轉換成一檢測參數訊號; 利用電化學處理單元13將檢測參數訊號精油無線傳輸單元14發送至為與試片改良結構機械性連接的接收元;以及 將所述檢測參數訊號顯示於接收元的一顯示器。 In an exemplary, non-limiting embodiment, the aforementioned improved structure of the test strip can be applied to an electrochemical sensing method, and the method includes the following steps in sequence: Use the power activation means to activate the power supply unit 15 to supply power to the electrochemical processing unit 13 and the wireless transmission unit 14, thereby awakening the electrochemical processing unit 13 and the wireless transmission unit 14; Utilize the electrochemical processing unit 13 to issue a control signal to the detection circuit 111 for performing detection; After the detection circuit 111 receives the control signal, the detection circuit 111 is used to carry out an electrochemical reaction with the sample to be detected, and a feedback signal is returned to the electrochemical processing unit 13; Using the electrochemical processing unit 13 to convert the feedback signal into a detection parameter signal; Utilize the electrochemical processing unit 13 to send the detection parameter signal to the essential oil wireless transmission unit 14 to the receiving unit that is mechanically connected to the improved structure of the test piece; and The detection parameter signal is displayed on a display of the receiving unit.

10:試片本體 101:第一端 102:第二端 103:上表面 104:下表面 11:檢測區 111:檢測電路 12:電路區 13:電化學處理單元 14:無線傳輸單元 15:電源單元 16:基板 161:鏤空區 17:組裝電路板 18:簧片 20:收縮膜 30:保護殼 40:電源遮斷膜 50:墊高件 10: Test piece body 101: First End 102: Second End 103: Upper surface 104: Lower surface 11: Detection area 111: Detection circuit 12: Circuit area 13: Electrochemical processing unit 14: Wireless transmission unit 15: Power supply unit 16: Substrate 161: Hollow area 17: Assemble the circuit board 18: Reed 20: Shrink film 30: protective case 40: Power interruption film 50: Elevator piece

第1圖為本發明第一實施例的試片改良結構的立體圖。FIG. 1 is a perspective view of the improved structure of the test piece according to the first embodiment of the present invention.

第2圖為本發明第一實施例的試片改良結構的另一立體圖。FIG. 2 is another perspective view of the improved structure of the test piece according to the first embodiment of the present invention.

第3圖為本發明第一實施例的試片改良結構的分解圖。FIG. 3 is an exploded view of the improved structure of the test piece according to the first embodiment of the present invention.

第4圖為本發明第一實施例的試片改良結構中的試片本體的分解圖。FIG. 4 is an exploded view of the test piece body in the improved structure of the test piece according to the first embodiment of the present invention.

第5圖為本發明第一實施例的試片改良結構的側視圖。Fig. 5 is a side view of the improved structure of the test piece according to the first embodiment of the present invention.

第6圖為本發明第二實施例的試片改良結構的側視圖。Fig. 6 is a side view of the improved structure of the test piece according to the second embodiment of the present invention.

10:試片本體 10: Test piece body

101:第一端 101: First End

102:第二端 102: Second End

104:下表面 104: Lower surface

50:墊高件 50: Elevator piece

Claims (6)

一種試片改良結構,包括: 一試片本體,具有一供與待檢測試樣接觸的檢測區及一不供與所述待檢測試樣接觸的電路區,該檢測區具有檢測電路,該檢測電路與該電路區電性連接,且該檢測電路是供與所述待檢測試樣進行電化學反應;其中,該試片本體具有一第一端、一相反於該第一端的第二端、一上表面及一下表面,該檢測電路位於該第一端的所述上表面;以及 一墊高件,設於該試片本體的所述下表面,用以在該試片改良結構平放於一桌面時讓該試片本體的所述第一端高於該第二端。 An improved structure of a test piece, comprising: A test piece body, which has a detection area for contact with the sample to be detected and a circuit area for contact with the sample to be detected, the detection area has a detection circuit, and the detection circuit is electrically connected to the circuit area , and the detection circuit is used for electrochemical reaction with the sample to be detected; wherein, the test piece body has a first end, a second end opposite to the first end, an upper surface and a lower surface, the detection circuit is located on the upper surface of the first end; and A booster is arranged on the lower surface of the test piece body, and is used to make the first end of the test piece body higher than the second end when the test piece improved structure is laid flat on a desktop. 如請求項1所述的試片改良結構,其中該試片本體更具有設於該電路區的一電化學處理單元、一無線傳輸單元及一電源單元,該保護層不直接接觸該電化學處理單元、該無線傳輸單元及該電源單元,該檢測電路與該電化學處理單元電性連接,該電化學處理單元用以對該檢測電路發出用於執行檢測的控制訊號,該檢測電路用以在收到該控制訊號後與所述待檢測試樣進行電化學反應並向該電化學處理單元回授一反餽訊號,該電化學處理單元更用以將該反餽訊號轉換成一檢測參數訊號,並用以將該檢測參數訊號經由該無線傳輸單元發送至一未與該拋棄式自感測訊號試片機械性連接的接收元,該電源單元用以供給電力給該電化學處理單元及該無線傳輸單元。The improved structure of the test strip as claimed in claim 1, wherein the test strip body further has an electrochemical processing unit, a wireless transmission unit and a power supply unit disposed in the circuit area, and the protective layer does not directly contact the electrochemical processing unit, the wireless transmission unit and the power supply unit, the detection circuit is electrically connected with the electrochemical processing unit, the electrochemical processing unit is used for sending a control signal for performing detection to the detection circuit, and the detection circuit is used for After receiving the control signal, electrochemical reaction is carried out with the sample to be detected and a feedback signal is fed back to the electrochemical processing unit. The electrochemical processing unit is further used to convert the feedback signal into a detection parameter signal and use it to The detection parameter signal is sent to a receiving unit not mechanically connected with the disposable self-sensing signal test piece through the wireless transmission unit, and the power supply unit is used for supplying power to the electrochemical processing unit and the wireless transmission unit. 如請求項2所述的試片改良結構,更包括一電源激活手段,用以供使用者選擇性激活該電源單元向該電化學處理單元及該無線傳輸單元供給電力的能力。The improved structure of the test strip as claimed in claim 2 further includes a power activation means for a user to selectively activate the capability of the power supply unit to supply power to the electrochemical processing unit and the wireless transmission unit. 如請求項2或3所述試片改良結構,其中該試片本體包括一基板及一組裝電路板,該檢測電路設於該基板,該電化學處理單元、該無線傳輸單元及該電源單元設於該組裝電路板。The improved structure of the test piece according to claim 2 or 3, wherein the test piece body comprises a substrate and an assembled circuit board, the detection circuit is arranged on the substrate, the electrochemical processing unit, the wireless transmission unit and the power supply unit are arranged on the assembled circuit board. 如請求項4所述試片改良結構,其中該基板具有至少一鏤空區,該電化學處理單元、該無線傳輸單元及該電源單元容置於該至少一鏤空區。The improved structure of the test piece according to claim 4, wherein the substrate has at least one hollow area, and the electrochemical processing unit, the wireless transmission unit and the power supply unit are accommodated in the at least one hollow area. 如請求項4所述試片改良結構,更包括一電源遮斷膜,該試片本體更包括一與該電路層電性連接的簧片,該電源遮斷膜可移動地設於該基板及該組裝電路板之間且可自一遮斷位置被抽離,當該電源遮斷膜位於該遮斷位置時,該電源遮斷膜間隔於該簧片與該電源單元之間而使該電源單元無法向該電化學處理單元及該無線傳輸單元供給電力,當該電源遮斷膜自該遮斷位置被抽離時,該簧片與該電源單元形成電性連接而使該電源單元向該電化學處理單元及該無線傳輸單元供給電力的能力被激活。The improved structure of the test piece according to claim 4, further comprises a power interruption film, the test piece body further comprises a reed electrically connected to the circuit layer, and the power interruption film is movably arranged on the substrate and the circuit layer. Between the assembled circuit boards and can be pulled away from a blocking position, when the power blocking film is located at the blocking position, the power blocking film is spaced between the reed and the power supply unit so that the power The unit cannot supply power to the electrochemical processing unit and the wireless transmission unit. When the power supply blocking film is pulled away from the blocking position, the reed is electrically connected to the power supply unit so that the power supply unit is connected to the power supply unit. The electrochemical processing unit and the ability of the wireless transmission unit to supply power are activated.
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