本发明涉及医用器械的技术领域，特别是涉及一种可行多导联心电图检查的手持式心电图仪；使用配套的心电图仪手环腕带可将该心电图仪当智能手环使用；使用配套的心电图仪套后该心电图仪可实现心电图检查、心电监测、实时远程心电监护等功能。The present invention relates to the technical field of medical devices, in particular to a handheld electrocardiograph capable of multi-lead electrocardiogram inspection; using a matching electrocardiograph wristband can use the electrocardiograph as a smart bracelet; using a matching electrocardiograph After the instrument is set, the electrocardiograph can realize functions such as electrocardiogram inspection, electrocardiogram monitoring, and real-time remote electrocardio monitoring.
心血管疾病严重危害人类健康, 其发病时具有突发性、短暂性和危险性的特点，如心绞痛发作、阵发性心律失常、心源性晕厥发作等，其通常诊断金标准是发作当时的心电图，必要时需要和平时心电图对比。心源性晕厥虽然只占到晕厥病因的15%，然而却是晕厥导致猝死的首要原因，其直接原因主要是恶性室性心律失常，这就要求尽快明确诊断。但是由于心绞痛、阵发性心律失常、晕厥发作的偶发性和不可预测性等特点, 往往很难获得发作当时的心电图，当患者赶往医院排队、检查时，极有可能心脏不适症状已经过去。目前临床上多采用24h 动态心电图（holter）捕捉短暂性的心电图心肌缺血改变、心律失常等，但对几天、几周、几个月甚至几年才发生一次的心绞痛、阵发性心律失常、晕厥还是存在局限，24h 动态心电图很难刚好捕捉到发作时的心电图。急性心肌梗死绝大部分可以通过心电图诊断出来，而且要求尽快行心电图检查以明确诊断，但是很多患者由于离医院、诊所等可以查心电图地方太远或者患者不重视而没有及时行心电图检查，因此耽误疾病的及时治疗甚至导致患者死亡。如果患者能够像糖尿病病人随身携带血糖仪进行自我血糖监测一样随身携带心电图仪以随时随地做心电图和心电监测，那么就能够解决这个问题。为了解决这个问题，那么就要求检查心电图的仪器应该足够小，并且电极应尽可能少，使用简单，容易操作。Cardiovascular disease seriously endangers human health. It has the characteristics of sudden, transient and dangerous when it occurs, such as angina pectoris, paroxysmal arrhythmia, cardiogenic syncope, etc. The gold standard for diagnosis is usually at the time of the onset Electrocardiogram, when necessary, need to compare with normal ECG. Although cardiogenic syncope accounts for only 15% of the causes of syncope, it is the primary cause of sudden death caused by syncope. The direct cause is mainly malignant ventricular arrhythmia, which requires a clear diagnosis as soon as possible. However, due to the sporadic and unpredictable characteristics of angina, paroxysmal arrhythmia, and syncope, it is often difficult to obtain the ECG at the time of the attack. When the patient rushes to the hospital to queue for examination, it is very likely that the symptoms of cardiac discomfort have passed. At present, 24h dynamic electrocardiogram (holter) is often used clinically to capture transient ECG myocardial ischemic changes, arrhythmia, etc., but for angina pectoris and paroxysmal arrhythmias that occur only once in a few days, weeks, months, or even years There are still limitations to syncope, and it is difficult for 24h Holter to capture the ECG at the time of the attack. Most of the acute myocardial infarction can be diagnosed by electrocardiogram, and it is required to perform an electrocardiogram as soon as possible to confirm the diagnosis, but many patients are too far away from the hospital, clinic, etc. where the electrocardiogram can be checked or the patient does not pay attention to it and does not take the electrocardiogram in time, so it is delayed The timely treatment of the disease may even lead to the death of the patient. If patients can carry an electrocardiograph with them to do ECG and ECG monitoring anytime and anywhere, just like diabetic patients with a blood glucose meter for self-blood glucose monitoring, then this problem can be solved. In order to solve this problem, it is required that the instrument for checking the electrocardiogram should be small enough, and the electrodes should be as few as possible, simple to use and easy to operate.
目前市场流行的可穿戴/移动心电设备可分为：光学心率式（PPG）、单导接触式、单导贴片式和标准导联式（多导）。除光学心率式外其他三种都是通过测量心电信号来判断使用者的心率情况，原理和心电图机类似。1.光学心率式（PPG）：光学心率式采用光电透射测量法，手环与皮肤接触的传感器会发出一束光打在皮肤上，测量反射/透射的光。因为血液对特定波长的光有吸收作用，每次心脏泵血时，该波长都会被大量吸收，以此就可以确定心跳。市场上大部分的可测心率的手环、手表均属这一类别。此类产品无论是原理还是精准度都不能满足医疗级别的要求，只能作为日常数据的追踪，不具医学参考价值。2.单导接触式：即不使用粘贴电极片，常用的是模拟胸导联和双手导联（Ⅰ导联），满足用户进行快速心电检测的需求；此类心电设备只能监测一个导联，大部分是Ⅰ导联，部分是胸导联或者二选一，可以检出较少部分（10-12种）的心律失常。由于此类设备需要用户手持或接触方能测量，仅能满足短时测量的场景，无法进行长时间监测，而短时的单导联的监测从医学角度来说是没有太多临床意义的，但是如果捕捉到心律失常发作时心电图还是有一定临床意义的。市场上高端的智能手环和智能手表多采用的是ECG+ PPG相结合的方式进行心率健康实时监测。3.单导贴片式：与手持/接触式不同，单导贴片式在有存储功能的前提下可适用于连续长时间检测。从临床的角度，单导设备当且仅当在连续长时间（>24h）佩戴测试场景下才有真正的临床意义，对心律失常的诊出率可以媲美动态心电（Holter）甚至优于Holter。然而很多厂商即便是单导贴片式，也并没有专门针对性的设计长时佩戴的场景，要么设备只能通过蓝牙连接实时显示，要么通过网络实时传输，没有涉及长时记录存储的领域，白白浪费了单导贴片式最适宜的长时动态监测性能；而且单导贴片只能监测心律失常，仅有一个导联，2个电极间距太短，波形常不稳定，从而限制临床应用。4.标准导联式（多导）：如果能够达到医疗级，那其实就是临床所使用的心电图和/或动态心电图。综上所述，目前光电心率式不具备医学参考价值；单导接触式只能短时间的单导联的监测，从医学角度来说是没有太多临床意义的；单导贴片只能监测一个导联，仅能用于心律失常监测，而且单导贴片式2个电极间距太短，波形常不稳定，从而限制临床应用；标准导联式、动态心电图、遥测心电监护导联多、结构复杂、体积大，患者一般无法自行行心电监测，无法长期随身携带，无法做到随时需要随时做心电图；所以目前市场上的可穿戴/移动心电设备均无法达到随时随地行心电图检查和自我心电监测的目标，也无法做出可真正用于临床使用分析的心电图。At present, the popular wearable/mobile ECG devices in the market can be divided into: optical heart rate (PPG), single-lead contact type, single-lead patch type and standard lead type (multi-lead). Except for the optical heart rate type, the other three are to determine the user's heart rate by measuring the ECG signal, and the principle is similar to that of an electrocardiograph. 1. Optical heart rate type (PPG): Optical heart rate type uses photoelectric transmission measurement method. The sensor of the wristband in contact with the skin emits a beam of light hitting the skin to measure the reflected/transmitted light. Because blood absorbs light of a specific wavelength, every time the heart pumps blood, this wavelength will be absorbed in a large amount, so that the heartbeat can be determined. Most of the bracelets and watches that can measure heart rate on the market belong to this category. Such products cannot meet the requirements of medical level in terms of principle and accuracy, and can only be used as daily data tracking, and have no medical reference value. 2. Single-lead contact type: that is, no sticky electrode pads are used, and the commonly used analog chest leads and two-hand leads (Lead Ⅰ) are commonly used to meet the needs of users for rapid ECG detection; this type of ECG equipment can only monitor one Most of the leads are Ⅰ lead, some are thoracic leads or choose one of the two leads, a small part (10-12 types) of arrhythmia can be detected. Because this type of device requires the user to hold or touch it to measure, it can only meet the short-term measurement scenario and cannot perform long-term monitoring. However, short-term single-lead monitoring does not have much clinical significance from a medical point of view. However, if the electrocardiogram is captured at the onset of arrhythmia, it still has certain clinical significance. Most high-end smart bracelets and smart watches on the market use ECG+Real-time monitoring of heart rate health by combining PPG. 3. Single-guide patch type: Different from the handheld/contact type, the single-guide patch type can be used for continuous long-term detection under the premise of storage function. From a clinical point of view, a single-lead device has real clinical significance if and only if it is worn for a continuous long time (>24h) in the test scenario, and the diagnosis rate for arrhythmia can be comparable to Holter or even better than Holter . However, many manufacturers do not specifically design long-term wearing scenarios even if they are single-lead patch type. Either the device can only be displayed in real time via Bluetooth connection, or it can be transmitted in real time through the network, and it does not involve the field of long-term record storage. The most suitable long-term dynamic monitoring performance of the single-lead patch is wasted in vain; and the single-lead patch can only monitor arrhythmia, there is only one lead, the distance between the two electrodes is too short, and the waveform is often unstable, which limits the clinical application . 4. Standard lead (multi-lead): If it can reach medical grade, it is actually the ECG and/or Holter used in clinic. In summary, the current photoelectric heart rate method does not have medical reference value; the single-lead contact type can only be used for short-term single-lead monitoring, which does not have much clinical significance from the medical point of view; the single-lead patch can only monitor One lead can only be used for arrhythmia monitoring, and the distance between the two electrodes of the single-lead patch type is too short, and the waveform is often unstable, which limits the clinical application; standard lead, Holter, telemetry ECG monitoring leads are many , Complex structure, large volume, patients generally cannot perform ECG monitoring on their own, cannot carry it with them for a long time, and cannot do ECG at any time; therefore, the current wearable/mobile ECG devices on the market cannot achieve ECG inspection anytime and anywhere. And the goal of self-electrocardiogram monitoring, it is impossible to make an electrocardiogram that can be used for clinical analysis.
事实上根据电子学测试原理，任何心电导联系统本质上讲都是双极导联。将双极导联的两极（正极和负极）置于人体表面上任意两点都能记录出心电波波形来。标准导联系统的Wilson胸导联系统我们常常描述为单极胸导联，其实也是双极导联，只不过把左上肢、右上肢、左下肢所连接成的中心电站当成负极（也就是所谓的无关电极或者参考电极）。In fact, according to the principle of electronic testing, any ECG lead system is essentially a bipolar lead. Placing the two poles (positive and negative) of the bipolar lead on any two points on the surface of the human body can record the ECG waveform. The Wilson chest lead system of the standard lead system is often described as a unipolar chest lead, but it is also a bipolar lead, except that the central power station connected by the left upper limb, right upper limb, and left lower limb is regarded as the negative electrode (the so-called Irrelevant electrode or reference electrode).
尽管右上肢-胸部双极导联（CR导联）心电图和标准导联心电图存在着差异，但是国内外多项研究证实CR导联心电图在临床成功应用。CR导联曾经成功应用于心脏疾病诊断大约20年，所以相关研究比较多。目前国内外有不少双极胸导联（包括CR导联、CL导联、CF导联，主要研究是CR导联）和常规胸导联对比研究，研究表明CR导联比起CL、CF导联具有相当多的优势，而且CR导联和常规胸导联心电图十分相似。De Gasperi, R. N、McCulloh初步研究表明仅仅使用2个电极的双极导联就可以对心脏电位进行充分分析，该研究的双极导联包括CR导联、腹部-上肢导联（该研究为脐上分别和右上肢、左上肢相连接的2个双极导联）；De Gasperi, R. N、Duncan, R. CLowery, M. H、Chakko, C. S、Sequeira, R. F.研究表明尽管CR导联和标准导联P、Q、R、S和T低波幅有较小差异，但二者心电图诊断一致率接近90％；D. HMeneses-Hoyos J, Gonzalez-Tamayo A的研究表明CR导联和标准胸导联对比没有显著意义的差别，可以用于临床对心律失常、心肌缺血、心肌梗死等的诊断。CR导联更容易使用，而且仅仅要求2个导联就可以，可以将心电图仪做的更小，满足自我心电监测的硬件、软件要求。Although there are differences between the right upper limb-chest bipolar lead (CR lead) ECG and the standard lead ECG, many domestic and foreign studies have confirmed the successful clinical application of CR lead ECG. The CR lead has been successfully used in the diagnosis of heart diseases for about 20 years, so there are more related studies. At present, there are many bipolar chest leads at home and abroad (including CR, CL, CF, and the main research is CR) and conventional chest leads. The research shows that CR leads are better than CL and CF. Leads have quite a few advantages, and the CR lead is very similar to the conventional chest lead ECG. A preliminary study by De Gasperi, R. N, and McCulloh showed that the bipolar lead with only two electrodes can be used to fully analyze the cardiac potential. The bipolar leads in this study include CR leads and abdominal-upper limb leads (the study Two bipolar leads on the umbilicus connected to the upper right limb and the upper left limb respectively); De Gasperi, R. N, Duncan,R. Lowery, M. H, Chakko, C. S, Sequeira, RF research shows that although CR leads and standard leads P, Q, R, S, and T have small differences in low amplitude, their ECG diagnostic agreement rate Close to 90%; D. HMeneses-Hoyos J, Gonzalez-Tamayo A research shows that there is no significant difference between CR lead and standard chest lead, which can be used for clinical diagnosis of arrhythmia, myocardial ischemia, myocardial infarction, etc. . The CR lead is easier to use, and only 2 leads are required. The electrocardiograph can be made smaller to meet the hardware and software requirements of self-electrocardiogram monitoring.
右上肢-胸部双极导联（CR导联）仅仅需要2个导联就可以满足临床心电图需要，为满足机身足够小、并且电极应尽可能少、使用简单、容易操作的要求，所以采用双极导联心电图仪设计来达到体积小、导联少、操作简单目的，以达到随时随地行心电图检查和自我心电监测的目标。The right upper limb-chest bipolar lead (CR lead) only needs 2 leads to meet the needs of clinical ECG. In order to meet the requirements of small enough body, as few electrodes as possible, simple use and easy operation, it is adopted The bipolar lead electrocardiograph is designed to achieve the purpose of small size, fewer leads, and simple operation, so as to achieve the goals of ECG examination and self-electrocardiogram monitoring anytime and anywhere.
目前市场流行的可穿戴/移动心电设备：1.光电心率式不具医学参考价值；2.单导接触式只能短时间的单导联的监测，从医学角度来说是没有太多临床意义的；3. 单导贴片只能监测一个导联，仅能用于心律失常监测，而且单导贴片式2个电极间距太短，波形常不稳定，从而限制临床应用；4.标准导联式、动态心电图、遥测心电监护存在导联多、结构复杂、体积大，患者无法长期随身携带，一般无法自行行心电监测，无法做到随时需要随时做心电图和心电监测。所以目前市场上的可穿戴/移动心电设备均无法达到随时随地行心电图检查和自我心电监测的目标，也无法做出可真正用于临床使用分析的心电图。The currently popular wearable/mobile ECG devices in the market: 1. The photoelectric heart rate type is not of medical reference value; 2. The single-lead contact type can only be used for short-term single-lead monitoring, which is not of much clinical significance from a medical point of view. 3. The single-lead patch can only monitor one lead, which can only be used for arrhythmia monitoring, and the distance between the two electrodes of the single-lead patch is too short, and the waveform is often unstable, which limits clinical applications; 4. Standard lead Connected, Holter ECG, and telemetry ECG monitoring have many leads, complex structure, and large size. Patients cannot carry them with them for a long time. Generally, they cannot perform ECG monitoring on their own, and cannot do ECG and ECG monitoring at any time. Therefore, none of the wearable/mobile ECG devices currently on the market can achieve the goal of performing ECG examination and self ECG monitoring anytime and anywhere, and cannot produce ECG that can be truly used for clinical analysis.
本发明采用手持式多点检测来解决上述技术问题，用仅仅2个电极的心电图仪做出可用于临床分析使用的多导联心电图（右手导联心电图）；该心电图（右手导联心电图）可以经计算推导出标准导联心电图；使用配套的心电图仪手环腕带可将该心电图仪当智能手环使用；使用配套的心电图仪套后该心电图仪可实现心电图检查、心电监测；持续心电监测时也可以通过蓝牙连接手机或者心电图仪内置的手机模块、WiFi等方式和远程监护仪配合使用进行实时远程心电监护。解决临床患者无法随时随地做心电图和心电监测的临床空白，适合临床上的广泛应用。The present invention uses handheld multi-point detection to solve the above technical problems, and uses an electrocardiograph with only 2 electrodes to make a multi-lead electrocardiogram (right-hand lead electrocardiogram) that can be used for clinical analysis; this electrocardiogram (right-hand lead electrocardiogram) can The standard lead electrocardiogram is derived by calculation; the electrocardiograph can be used as a smart bracelet by using the matching electrocardiograph wristband; the electrocardiograph can be used for ECG inspection and ECG monitoring after using the matching electrocardiograph sleeve; During electrical monitoring, it can also be connected to a mobile phone or the built-in cell phone module of the electrocardiograph via Bluetooth, WiFi, etc., and used with a remote monitor for real-time remote ECG monitoring. It solves the clinical gap that clinical patients cannot do ECG and ECG monitoring anytime and anywhere, and is suitable for a wide range of clinical applications.
心电图仪内置心电图模块（13），心电图模块正极（1）位于心电图仪的一端并向主机部分机身底面延伸，为金属或者导电硅胶等导电材料形成电极；心电图模块负极（2）位于心电图仪的另外一端并向主机机身部分侧面延伸，以利于用右手握住心电图仪负极行心电图检查，为金属或者导电硅胶等导电材料形成电极。需要行心电图检查时，右手和检测点皮肤清洁后涂上导电膏或者生理盐水，右手握住心电图仪负极，然后让正极和标准导联的V1 ~V6、左上肢（或者左侧锁骨外1/3的下方）、左下肢（或者左腋前线于肋下缘和髂骨上缘中点）等检测点相接触（必要时可以加做V7 ~V9、V3R~V6R、剑突处等导联），记录并形成了多个导联心电图。做完心电图在心电图仪显示屏回放，也可以通过USB、蓝牙、WiFi、内置手机模块等（依据不同型号、功能设定）发送到手机或者电脑或者监测中心，然后通过相应软件进行心电图分析。在实际临床使用时如果紧急情况下而没有导电膏或者生理盐水时，可以直接行心电图检查，必要时可使用唾液、自来水等湿化电极做出心电图，实际试用效果还不错。The electrocardiograph has a built-in electrocardiograph module (13). The positive electrode of the electrocardiograph module (1) is located at one end of the electrocardiograph and extends to the bottom of the main body of the main body, forming electrodes for conductive materials such as metal or conductive silica gel; the negative pole of the electrocardiograph module (2) is located on the electrocardiograph The other end extends to the side of the main body of the main body to facilitate the electrocardiogram inspection by holding the negative electrode of the electrocardiograph with the right hand, forming electrodes for conductive materials such as metal or conductive silica gel. When an electrocardiogram is required, clean the skin of the right hand and the detection point and apply conductive paste or saline. Hold the negative electrode of the electrocardiograph with the right hand, and then connect the positive electrode to the standard lead V1~V6, the left upper limb (or below the 1/3 of the left clavicle), the left lower limb (or the left anterior axillary line at the midpoint of the lower edge of the rib and the upper edge of the iliac bone) and other detection points contact (V7 can be added if necessary~V9, V3R~V6R, xiphoid process and other leads), multiple lead electrocardiograms were recorded and formed. After the electrocardiogram is completed, it will be played back on the electrocardiograph display, or it can be sent to a mobile phone or computer or monitoring center via USB, Bluetooth, WiFi, built-in mobile phone module, etc. (depending on different models and function settings), and then the electrocardiogram can be analyzed through the corresponding software. In the actual clinical use, if there is no conductive paste or saline in an emergency, the ECG can be directly checked. If necessary, saliva, tap water and other humidified electrodes can be used to make the ECG. The actual trial effect is not bad.
心电图仪有心电图导联线连接端口（3），用于通过心电图仪套连接心电图导联线（12），示意图为3个导联线接口，实际上依据心电图仪不同型号、功能设定，导联线连接端口可以为2个或者2个以上多个接口。The electrocardiograph has an electrocardiograph lead wire connection port (3), which is used to connect the electrocardiogram lead wire (12) through the electrocardiograph sleeve. The in-line connection ports can be two or more than two ports.
心电图仪有多功能按键（8）：轻按一下则开始行心电图检查，启动后按照显示屏操作提示进行心电图检查，在做心电图时同时可查看波形，心电图检查完毕后再确定是否发送以及发送到哪儿；在进行持续心电监测是轻按可点亮显示屏查看心电图波形；长按则启动紧急情况，这时则边做心电图边发送图像以免耽误病情，并且可以按事先设定仅作几个重要导联，情况允许再做其他导联；在行持续心电监测时长按可以发送按下按钮前后10秒（具体时间可以设定）的心电图并在心电监测记录中做标志，以方便回放查看；在实时远程监护时长按可以在心电监测记录中做标志并同时提醒监护医务人员。The electrocardiograph has a multi-function button (8): lightly press it to start the ECG check. After starting, follow the instructions on the display to check the ECG. You can check the waveform while doing the ECG. After the ECG check is completed, confirm whether to send and send to Where: During continuous ECG monitoring, tap lightly to turn on the display to view the ECG waveform; long press to start an emergency situation, at this time, while doing the ECG and sending images to avoid delaying the condition, and you can only do a few according to the pre-set For important leads, other leads can be used in the situation; long press during continuous ECG monitoring can send the ECG 10 seconds before and after pressing the button (the specific time can be set) and mark it in the ECG monitoring record to facilitate playback and review ; Long press during real-time remote monitoring can mark the ECG monitoring record and remind the monitoring medical staff at the same time.
心电图仪内置的心电图模块（13）主要由心电信号采集、放大、滤波电路、A/D 转换器、控制与数据处理器等构成。心电图模块控制与数据处理器采用心电图仪内置处理器，因此心电图仪可用于控制心电信号检测的启动、停止、存储和传送等操作，或者手机通过蓝牙、WiFi等控制心电图仪心电信号检测的启动、停止、存储和传送等操作。The ECG module (13) built into the electrocardiograph is mainly composed of ECG signal acquisition, amplification, filter circuit, A/D converter, control and data processor, etc. The ECG module control and data processor uses the built-in processor of the ECG, so the ECG can be used to control the start, stop, storage and transmission of the ECG signal detection, or the mobile phone can control the ECG signal detection of the ECG through Bluetooth, WiFi, etc. Start, stop, store and transfer operations.
心电图仪还具备心电信号处理和传输模块（14）、主机屏幕（5）、用于充电和数据传输用的USB接口（4）、电源模块、存储模块等，手机通信模块、蓝牙模块、WiFi模块、卫星定位模块等依据心电图仪的不同型号、功能按需要设定。The electrocardiograph is also equipped with ECG signal processing and transmission module (14), host screen (5), USB interface (4) for charging and data transmission, power supply module, storage module, etc., mobile phone communication module, Bluetooth module, WiFi Modules, satellite positioning modules, etc. are set according to different models and functions of the electrocardiograph.
心电图仪有配套的手环腕带。手环腕带正极（6）为手环腕带和心电图仪正极的接触面并向腕带延伸的部分腕带，由金属或者导电硅胶等导电材料所形成电极；手环腕带负极（7）为手环腕带和心电图仪负极的接触面并向腕带延伸的部分腕带，由金属或者导电硅胶等导电材料所形成电极。手环腕带正极为通透性，手环腕带正极内外面均可用于采集心电信号，当佩戴手环腕带时可以通过手环腕带正极采集心电图正极信号到心电图仪；手环腕带负极为非通透性，腕带负极内侧面和手腕接触面为非导电性，当佩戴手环腕带时另外一只手和手环腕带负极接触可以采集心电图负极信号到心电图仪。当心电图仪装入手环腕带后佩戴手环时，心电正极信号可以同时通过手环腕带正极、心电图仪正极和手腕接触面采集心电信号，通过另外一只手接触手环腕带负极采集心电负极信号。由于心电信号采集是在主要是手环腕带上，可以设计较大的接触面积，这样即可以大大的提高心电图模块信号采集面积，提高心电信号采集的可靠性，而且不占用心电图仪正面，可以大大提高心电图仪的屏占比；临床在采集心电信号时往往在电极涂导电膏或者生理盐水以降低电阻，提高心电信号采集的可靠性；本发明设计采用手环腕带采集心电信号，涂导电膏或者生理盐水在腕带上可以避免导电膏或者生理盐水对心电图仪的潜在伤害。The electrocardiograph has a matching wristband. The positive electrode of the wristband (6) is the part of the wristband that is the contact surface between the wristband of the wristband and the positive electrode of the electrocardiograph and extends to the wristband. The electrode is formed of conductive materials such as metal or conductive silica gel; the negative electrode of the wristband (7) The part of the wristband that is the contact surface between the wristband of the wristband and the negative electrode of the electrocardiograph and extends to the wristband. The electrodes are formed of conductive materials such as metal or conductive silica gel. The positive electrode of the wristband of the wristband is transparent. Both the inside and outside of the positive electrode of the wristband can be used to collect ECG signals. When the wristband is worn, the positive electrode signal of the ECG can be collected to the electrocardiograph through the positive electrode of the wristband. The negative pole of the strap is impermeable, and the inner side of the negative pole of the wrist strap and the contact surface of the wrist are non-conductive. When the wrist strap is worn, the other hand is in contact with the negative pole of the wrist strap to collect the negative signal of the ECG to the electrocardiograph. When the electrocardiograph is installed in the wristband and the wristband is worn, the positive signal of the ECG can be collected through the positive electrode of the wristband, the positive electrode of the electrocardiograph and the wrist contact surface at the same time, and the negative electrode of the wristband can be contacted with the other hand. Collect the negative signal of the ECG. Since the ECG signal collection is mainly on the wristband of the wristband, a larger contact area can be designed, which can greatly increase the signal collection area of the ECG module, improve the reliability of the ECG signal collection, and does not occupy the front of the electrocardiograph , It can greatly increase the screen-to-body ratio of the electrocardiograph; when collecting ECG signals in clinical practice, conductive paste or saline is often applied to the electrodes to reduce resistance and improve the reliability of ECG signal collection; the present invention uses a wristband to collect heart signals. For electrical signals, apply conductive paste or saline on the wristband to avoid potential damage to the electrocardiograph.
当心电图仪装入手环腕带时，需要行心电图检查时，左手佩戴手环腕带，右手和手环腕带负极接触，采集I导联心电信号，主要是用于心律失常的即时监测。当心电图仪装入手环腕带时，也可以采用手持式多点检测法：右手和检测点皮肤清洁后涂上导电膏或者生理盐水，右手握住手环腕带负极，然后分别让手环腕带正极和标准导联的V1 ~V6、左上肢（或者左侧锁骨外1/3的下方）、左下肢（或者左腋前线于肋下缘和髂骨上缘中点）等检测点相接触（必要时可以加做V7 ~V9、V3R~V6R、剑突处等导联），采集多个导联心电图数据。做完心电图可在心电图仪显示屏回放，也可以通过USB、蓝牙、WiFi、内置手机模块等（依据不同型号、功能设定）发送到手机或者电脑或者监测中心等，通过相应软件进行心电图分析。在实际临床使用时如果紧急情况下而没有导电膏或者生理盐水时，可以直接行心电图检查，必要时可使用唾液、自来水等湿化电极做出心电图，实际试用效果还不错。When the electrocardiograph is installed in the wristband and the ECG examination is required, wear the wristband on the left hand and contact the negative electrode of the wristband on the right hand to collect the I-lead ECG signal, which is mainly used for real-time monitoring of arrhythmia. When the electrocardiograph is installed in the wristband of the wristband, the handheld multi-point detection method can also be used: clean the skin of the right hand and the detection point, apply conductive paste or saline, hold the negative electrode of the wristband with the right hand, and then use the wristband separately V1 with positive and standard leads~V6, the left upper limb (or below the 1/3 of the left clavicle), the left lower limb (or the left anterior axillary line at the midpoint of the lower edge of the rib and the upper edge of the iliac bone) and other detection points contact (V7 can be added if necessary ~ V9, V3R~V6R, xiphoid process and other leads), collect multiple leads of ECG data. After the ECG is completed, it can be played back on the electrocardiograph display, or sent to a mobile phone or computer or monitoring center via USB, Bluetooth, WiFi, built-in mobile phone module, etc. (depending on different models and function settings), and the ECG analysis can be performed through the corresponding software. In the actual clinical use, if there is no conductive paste or saline in an emergency, the ECG can be directly checked. If necessary, saliva, tap water and other humidified electrodes can be used to make the ECG. The actual trial effect is not bad.
心电图仪有配套的心电图仪套。心电图仪套和心电图仪正极接触部分为金属或者导电硅胶等导电材料形成心电图仪套正极（9）；心电图仪套心电图导联连接端口（10）和心电图仪心电图导联连接端口（3）相对应，可将导联线（12）接收的心电信号传递到心电图仪；导联线为2个或多个导联线（依据心电图仪不同型号、功能设定），用于持续心电监测和心电图检查以检测出阵发性心律失常、阵发性心肌缺血以及早期发现心肌梗死等。当心电图仪装入心电图仪套时，可将各个导联线用一次性电极吸附于相应位置行心电监测，持续心电监测时也可以通过手机或者USB、蓝牙、WiFi、内置手机模块等和远程监护仪配合使用进行实时远程心电监护。当心电图仪装入心电图仪套时，也可以将各个导联线接上肢体夹或者心电吸球或者一次性电极，然后行心电图检查，详见下述。The electrocardiograph has a matching set of electrocardiograph. The contact part between the electrocardiograph sleeve and the electrocardiograph positive electrode is made of conductive materials such as metal or conductive silica gel to form the electrocardiograph sleeve positive electrode (9); the electrocardiograph lead connection port (10) of the electrocardiograph sleeve corresponds to the electrocardiograph lead connection port (3) , Can transmit the ECG signal received by the lead wire (12) to the electrocardiograph; the lead wire is 2 or more lead wires (depending on the different models and function settings of the electrocardiograph) for continuous ECG monitoring and The electrocardiogram is used to detect paroxysmal arrhythmia, paroxysmal myocardial ischemia, and early detection of myocardial infarction. When the electrocardiograph is installed in the electrocardiograph case, each lead wire can be attached to the corresponding position with disposable electrodes for ECG monitoring. During continuous ECG monitoring, it can also be monitored by mobile phones or USB, Bluetooth, WiFi, built-in mobile phone modules, etc. The remote monitor is used in conjunction to perform real-time remote ECG monitoring. When the electrocardiograph is installed in the electrocardiograph sleeve, you can also connect each lead wire to a limb clip or an ECG ball or disposable electrode, and then perform an ECG examination. See the following for details.
当心电图仪装入心电图仪套时，使用导联线行心电图检查具体方法依据导联线的不同分述如下：一、双导联线：心电图导联连接端口可接2条导联线，这2条导联线分别对应心电图仪负极和正极。将负极导联线分别连接于右上肢或者右侧锁骨外1/3的下方，然后右手握住正极分别在各个导联检测点采集心电信号，记录右手导联心电图。二、三导联线：心电图导联连接端口可接3条导联线，这3条导联线分别为右上肢导联（对应心电图仪机身负极）、左上肢导联、左下肢导联。心电图仪底部正极没有对应的导联线。将3条导联线分别连接于右上肢、左上肢、左下肢或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，然后右手握住心电图仪套，用底部正极分别在胸导联检测点采集心电信号，记录标准导联心电图，而不是经过计算、推导的标准导联心电图。用这种方法仅仅需要3条导联线就可以采集标准导联心电图，强烈推荐应用。三、多导联线：心电图导联连接端口可接多条导联线，这些导联线分别为相应肢导联和胸导联（图示为9个导联线，实际应用依据不同型号、功能设定不同导联线数量）。将肢导导联线分别连接于相应肢体或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，胸导连接在相应胸导联检测点；也可以将3条肢体导联线分别连接于相应肢体或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，然后用心电图仪套正极分别在胸导联检测点采集心电信号，这时相当于三导联线方式。多导联线记录心电图其实就是相当于普通心电图机采集心电图，但可能会存在成本高、机身庞大、耗电量大、导联线多、操作复杂等一系列问题，患者要随身携带心电图仪和行自我心电图检查、心电监测可能会比较困难。综上所述，心电图仪根据不同采集心电图的方法其心电图图像有右手导联心电图系统和常规标准导联心电图系统2种。When the electrocardiograph is installed in the electrocardiograph sleeve, the specific methods of using the lead wire for the electrocardiogram inspection are described as follows according to the different lead wires: 1. Double lead wire: The connection port of the electrocardiogram lead can be connected to 2 lead wires. The two lead wires correspond to the negative and positive electrodes of the electrocardiograph. Connect the negative lead wires to the right upper limb or under the outer 1/3 of the right clavicle, and then hold the positive electrode in your right hand to collect ECG signals at each lead detection point, and record the right hand lead ECG. Two and three-lead wires: The ECG lead connection port can be connected to 3 lead wires, which are the right upper limb lead (corresponding to the negative electrode of the electrocardiograph body), the left upper limb lead, and the left lower limb lead. . There is no corresponding lead wire at the bottom of the electrocardiograph. Connect the 3 lead wires to the right upper limb, left upper limb, left lower limb, or under the outer 1/3 of both sides of the clavicle, and the left anterior axillary line to the midpoint of the lower edge of the rib and the upper edge of the ilium, and then hold the electrocardiograph cover with your right hand , Use the bottom positive electrode to collect the ECG signal at the chest lead detection point, and record the standard lead ECG instead of the calculated and deduced standard lead ECG. With this method, only 3 leads are needed to collect standard lead ECG, which is highly recommended. 3. Multi-lead wire: The ECG lead connection port can be connected to multiple lead wires. These lead wires are the corresponding limb leads and chest leads (the figure shows 9 lead wires. The actual application depends on different models, Function to set the number of different lead wires). Connect the limb lead wires to the corresponding limbs or below the outer 1/3 of the clavicle on both sides, the left anterior axillary line to the midpoint of the lower edge of the rib and the upper edge of the iliac bone, and the chest lead to the corresponding chest lead detection point; Connect the three limb lead wires to the corresponding limbs or under the outer 1/3 of the clavicle on both sides, and the left anterior axillary line to the midpoint of the lower edge of the rib and the upper edge of the ilium, and then use the positive electrode of the electrocardiograph to detect the chest leads. Point to collect the ECG signal, which is equivalent to the three-lead wire mode at this time. Multi-lead wire recording ECG is actually equivalent to the normal ECG machine collecting ECG, but there may be a series of problems such as high cost, large body, high power consumption, multiple leads, and complicated operation. Patients should carry the ECG with them. It may be more difficult to conduct self-ECG examination and ECG monitoring. To sum up, according to the different methods of collecting ECG, the ECG image of the electrocardiograph has two types: the right-hand lead ECG system and the conventional standard lead ECG system.
心电图仪套多功能按键（11）和心电图仪多功能按键相对应（8），当心电图仪放入心电图仪套时按压心电图仪套多功能按键（11）可触发心电图仪的多功能按键（8）的功能。The multi-function button (11) of the electrocardiograph cover corresponds to the multi-function button of the electrocardiograph (8). When the electrocardiograph is put into the electrocardiograph cover, pressing the multi-function button (11) of the electrocardiograph can trigger the multi-function button (8) of the electrocardiograph. ) Function.
心电图仪导联设计包括：1. 右上肢-胸部双极导联（CR导联），可以模拟胸导联，其负极为右上肢，正极部位和Wilson导联系统的V导联一致；2.Ⅰ导联，其负极为右上肢（或者右侧锁骨外1/3的下方），正极位于左上肢（或者左侧锁骨外1/3的下方）；3.Ⅱ导联，其负极为右上肢（或者右侧锁骨外1/3的下方），正极为左下肢（或者左腋前线于肋下缘和髂骨上缘中点）。双极胸导联包括CR导联、CL导联、CF导联，Fontaine导联也称作双极胸导联，还有运动实验也有运动试验也有用双极胸导联，容易引起命名紊乱；而且本发明不仅包括右上肢-胸部双极导联（CR导联）还包括Ⅰ导联、Ⅱ导联，所有导联均采用负极为右上肢，所以为了方便直观，重新命名为右手导联（Right Hand Leads RH导联）。将各导联分别命名为：RHC1 ~RHC6、RHⅠ、RHⅡ，分别对应标准导联的V1 ~V6、Ⅰ、Ⅱ。统一将RHC1 ~RHC6 等胸导联统称为RHC导联，等同于以前的CR导联。其实RHC1 ~RHC6 就是CR1 ~CR6 的重新命名；RHⅠ、RHⅡ分别为标准导联的Ⅰ导联、Ⅱ导联。The lead design of the electrocardiograph includes: 1. Right upper limb-chest bipolar lead (CR lead), which can simulate the chest lead, the negative pole is the right upper limb, and the positive pole part is the same as the V lead of the Wilson lead system; 2. In lead Ⅰ, the negative pole is the right upper limb (or below the outer 1/3 of the right clavicle), and the positive pole is located in the left upper limb (or below the 1/3 of the left clavicle); in lead 3.Ⅱ, the negative pole is the right upper limb (Or below the outer 1/3 of the right clavicle), the positive pole is the left lower limb (or the left anterior axillary line is at the midpoint of the lower edge of the rib and the upper edge of the ilium). Bipolar chest leads include CR, CL, and CF leads. Fontaine lead is also called bipolar chest lead. There are also exercise experiments and exercise tests, as well as bipolar chest leads, which can easily cause naming confusion; Moreover, the present invention includes not only the right upper limb-chest bipolar lead (CR lead) but also leads I and II. All the leads adopt the negative pole as the right upper limb, so for convenience and intuitiveness, it is renamed the right hand lead ( RightHand Leads RH lead). Name the leads respectively: RHC1 ~RHC6, RHⅠ, RHⅡ, corresponding to the standard leads V1 ~V6, Ⅰ, Ⅱ. Unified RHC1~RHC6 and other chest leads are collectively referred to as RHC leads, which are equivalent to the previous CR leads. Actually RHC1 ~ RHC6 are CR1~CR6 is renamed; RHⅠ and RHⅡ are standard leads I and II respectively.
由右手导联推导出常规标准导联心电图：常规心电图导联连接图如图10所示，其中R、L、F分别代表右上肢、左上肢、左下肢；－代表负极，＋代表正极；WCT为Wilson中心电站；V代表标准导联胸导联位置，V1 ~V6，共6个，取一个点做示意，其中标准胸导联用Vn表示，右手导联用RHCn表示。用E代表电势。Ⅰ导联：心电图机正极连于左上肢，负极连于右上肢。故Ⅰ=EL－ER。Ⅱ导联：心电图机正极连于左下肢，负极连于右上肢。故Ⅱ=EF－ER。Ⅲ导联：心电图机正极连于左下肢，负极连于左上肢。故Ⅲ=EF－EL。根据上述3个公式，可推导出Ⅲ= EF－EL= (EF－ER)－( EL－ER)=Ⅱ－Ⅰ。同理，可推算出RHⅢ=RHⅡ－RHⅠ。中心电站（WCT）为R、L、F连接中心点，经数学计算EWCT=(EF＋EL＋ER)/3。 VR=ER－EWCT=ER－(EF＋EL＋ER)/3=－[( EF－ER)＋( EL－ER)]/3=－(Ⅰ＋Ⅱ)/3 VL= EL－EWCT=EL－(EF＋EL＋ER)/3=[( EL－ER) －(EF－EL)]/3=(Ⅰ－Ⅲ)/3=[Ⅰ－(Ⅱ－Ⅰ)]/3=(2Ⅰ－Ⅱ)/3 VF= EF－EWCT=EF－(EF＋EL＋ER)/3=[ (EF－EL )＋( EF－ER)]/3=(Ⅲ＋Ⅱ)/3=(Ⅱ－Ⅰ－Ⅱ)/3=(2Ⅱ－Ⅰ)/3 为了提高单极肢体导联电压，1942年Glodberger修改Wilson的中心电端，把中心电端与探查的那一个肢体脱离，将得到的电位增加到一半，计算公式如下。aVR= ER－(EF＋EL)/2= 3/2ER－(EF＋EL＋ER)/2=2/3 [ER－(EF＋EL＋ER)/3]=3/2VR=－(Ⅰ＋Ⅱ)/2 同理，aVL= 3/2VL= (2Ⅰ－Ⅱ)/2=Ⅰ－1/2Ⅱ；aVF= 3/2VF==(2Ⅱ－Ⅰ)/2=Ⅱ－1/2Ⅰ。导联Vn为正极连于在Vn，负极（无干电极）连于WCT。故Vn=EVn－EWCT。导联RHCn为正极连于在Vn，负极连于右上肢。故RHCn= EVn－ER。由此可推断出：Vn= EVn－EWCT= EVn－(EF＋EL＋ER)/3= EVn－ER＋[( EL－ER)＋( EF－ER)]/3=RHCn－(Ⅰ＋Ⅱ)/3。通过以上公式，本研究证实仅仅依靠2个电极的右手导联心电图系统在采集数据后经过计算机处理可以推断出常规标准导联心电图。常规标准的Ⅰ导联、Ⅱ导联、Ⅲ导联、aVR导联、aVL导联、aVF导联、胸导联的各个Vn导联分别用RHⅠ、RHⅡ、RHⅡ－ RHⅠ、－( RHⅠ＋ RHⅡ)/2、RHⅠ－1/2 RHⅡ、RHⅡ－1/2 RHⅠ、RHCn－( RHⅠ＋ RHⅡ)/3替代，从而导出标准导联心电图。因为右手导联心电图是新提出来的，而且大部分人对CR导联也不甚了解，所以经计算机转换出标准导联心电图有利于临床工作的开展，也有利于对心电图进行分析。注意RH导联系统RHⅠ和RHⅡ定位和标准导联系统区别，还有心电图不是多导联同步采集，所以计算后期合成心电图时心率不同时要先矫正后再合成，就算经校正，其本身可能存在偏差，不过心电图仪采集心电图虽然不是同步的，但因间隔时间很短，心率变异小，矫正后其影响很小。The conventional standard lead electrocardiogram is derived from the right-hand lead: the conventional electrocardiogram lead connection diagram is shown in Figure 10, where R, L, and F represent the right upper limb, left upper limb, and left lower limb respectively;-represents negative electrode, + represents positive electrode; WCT It is the Wilson Central Power Station; V represents the position of the standard lead chest lead, V1 ~ V6, there are 6 in total. Take one point as an indication. The standard chest lead is represented by Vn and the right-hand lead is represented by RHCn. Let E stand for electric potential. Lead I: The positive electrode of the electrocardiograph is connected to the upper left limb, and the negative electrode is connected to the upper right limb. Therefore Ⅰ=EL-ER. Lead II: The positive electrode of the electrocardiograph is connected to the left lower limb, and the negative electrode is connected to the right upper limb. Therefore Ⅱ=EF-ER. Lead III: The positive electrode of the electrocardiograph is connected to the left lower limb, and the negative electrode is connected to the left upper limb. Therefore Ⅲ=EF-EL. According to the above three formulas, it can be deduced that Ⅲ=EF-EL= (EF-ER)-(EL-ER)=Ⅱ-I. In the same way, RHⅢ=RHⅡ－RHⅠ can be calculated. The central power station (WCT) is the central point of the connection of R, L, and F. After mathematical calculation, EWCT=(EF＋EL＋ER)/3. VR=ER－EWCT=ER－(EF＋EL＋ER)/3=－[( EF－ER)＋( EL－ER)]/3=－(Ⅰ＋Ⅱ)/3 VL= EL－EWCT=EL－(EF＋EL＋ER)/3 =[( EL－ER) －(EF－EL)]/3=(Ⅰ－Ⅲ)/3=[Ⅰ－(Ⅱ－Ⅰ)]/3=(2Ⅰ－Ⅱ)/3 VF= EF－EWCT= EF－(EF＋EL＋ER)/3=[ (EF－EL )＋( EF－ER)]/3=(Ⅲ＋Ⅱ)/3=(Ⅱ－Ⅰ－Ⅱ)/3=(2Ⅱ－Ⅰ)/3 To increase the order Polar limb lead voltage. In 1942, Glodberger modified Wilson's central electrical terminal, separated the central electrical terminal from the limb being probed, and increased the obtained potential to half. The calculation formula is as follows. aVR= ER－(EF＋EL)/2= 3/2ER－(EF＋EL＋ER)/2=2/3 [ER－(EF＋EL＋ER)/3]=3/2VR=－(Ⅰ＋Ⅱ)/2 Similarly, aVL=3/2VL= (2Ⅰ－Ⅱ)/2=Ⅰ－1/2Ⅱ; aVF= 3/2VF==(2Ⅱ－Ⅰ)/2=Ⅱ－1/2Ⅰ. Lead Vn is the positive pole connected to Vn, and the negative pole (without dry electrode) is connected to WCT. So Vn=EVn-EWCT. Lead RHCn is connected to Vn with the positive pole and the negative pole to the upper right limb. So RHCn = EVn-ER. It can be inferred from this: Vn= EVn-EWCT= EVn-(EF+EL+ER)/3= EVn-ER+[( EL-ER)+(EF-ER)]/3=RHCn-(Ⅰ+Ⅱ)/3. Through the above formula, this study confirmed that the right-hand lead ECG system, which only relies on two electrodes, can infer the conventional standard lead ECG after the data is collected and processed by the computer. Conventional standard lead I, II, III, aVR, aVL, aVF, chest lead Vn leads respectively use RHⅠ, RHⅡ, RHⅡ-RHⅠ, -(RHⅠ＋RHⅡ) /2, RHⅠ－1/2 RHⅡ, RHⅡ－1/2 RHⅠ, RHCn－(RHⅠ＋RHⅡ)/3 replacement, so as to derive the standard lead electrocardiogram. Because the right-hand lead ECG is newly proposed, and most people don’t know much about the CR lead, the computer-converted standard lead ECG is beneficial to the development of clinical work and the analysis of the ECG. Pay attention to the difference between the RH I and RH II positioning of the RH lead system and the standard lead system, and the electrocardiogram is not collected simultaneously with multiple leads. Therefore, when the heart rate is different during the calculation of the later synthetic electrocardiogram, it must be corrected before synthesis. Even after correction, it may exist. Deviation, but although the ECG collected by the electrocardiograph is not synchronized, because the interval is very short, the heart rate variability is small, and its effect after correction is small.
心电图仪采用手持式多点检测的设计。行心电图检查时，右手握住心电图仪负极，正极和各个导联检测点相接触，记录并形成了可真正用于临床分析的多个导联心电图（右手导联心电图）。因为心电图仪可以仅仅2个电极，所以心电图仪可以做的非常小，方便随身携带；因为采用手持式多点检测的设计，患者可以随时拿出心电图仪并马上行心电图检查，不需要各种导联线的连接，简单方便，解决临床患者无法随时随地做心电图检查的临床空白。The electrocardiograph adopts a handheld multi-point detection design. When performing an ECG examination, hold the negative electrode of the electrocardiograph with the right hand, and the positive electrode is in contact with the detection points of each lead, and a multi-lead ECG (right-hand lead ECG) that can be used for clinical analysis is recorded and formed. Because the electrocardiograph can only have 2 electrodes, the electrocardiograph can be made very small and convenient to carry around; because of the handheld multi-point detection design, the patient can take out the electrocardiograph at any time and perform the electrocardiogram inspection immediately, without all kinds of guides. The online connection is simple and convenient, and solves the clinical gap that clinical patients cannot do ECG examination anytime and anywhere.
对既往的右上肢-胸部双极导联（CR导联）进行扩展研究。除了CR导联外，本发明还包括了Ⅰ导联、Ⅱ导联，构成了一个完整的导联体系，重新命名为右手导联（Right Hand Leads RH导联）。利用仅仅2个电极的心电图仪完成了可真正用于临床分析的多个导联心电图（右手导联心电图）的心电图数据采集。An extended study of the previous right upper limb-chest bipolar lead (lead CR). In addition to the CR lead, the present invention also includes lead I and lead II, forming a complete lead system, renamed the right-hand lead (RightHand Leads RH lead). The electrocardiograph with only 2 electrodes is used to complete the electrocardiogram data collection of multiple-lead electrocardiogram (right-hand lead electrocardiogram) that can be really used for clinical analysis.
创造性的利用完整的右手导联心电图体系，经计算推导出完整的常规标准导联心电图，以利于该心电图仪的临床推广应用。仅采用2个电极的心电图仪就完成了多个导联心电图数据采集，并用这些数据推导出完整的常规标准导联的心电图。Creative use of the complete right-hand lead electrocardiogram system, calculated to derive a complete conventional standard lead electrocardiogram, in order to facilitate the clinical application of the electrocardiograph. The electrocardiograph using only 2 electrodes can complete the multi-lead electrocardiogram data collection, and use these data to derive a complete conventional standard lead electrocardiogram.
心电图仪配套有手环腕带，手环腕带电极为手环腕带和心电图仪电极的接触面并向腕带延伸的部分腕带，由金属或者导电硅胶等导电材料所形成电极。由于心电信号采集是在主要是手环腕带上，可以设计较大的接触面积，这样即可以大大的提高心电图模块信号采集面积，提高心电信号采集的可靠性；手环腕带电极不占用心电图仪正面，可以大大提高心电图仪的屏占比；临床在采集心电信号时往往在电极涂导电膏或者生理盐水以降低电阻，提高心电信号采集的可靠性，采用手环腕带采集心电信号，涂导电膏或者生理盐水在腕带上可以避免导电膏或者生理盐水对心电图仪的潜在伤害。The electrocardiograph is equipped with a wristband and a wristband. The electrodes of the wristband are the part of the wristband that is the contact surface between the wristband of the wristband and the electrodes of the electrocardiograph and extends to the wristband. The electrodes are made of conductive materials such as metal or conductive silica gel. Since the ECG signal collection is mainly on the wristband of the wristband, a larger contact area can be designed, which can greatly increase the signal collection area of the ECG module and improve the reliability of the ECG signal collection; the wristband electrode is not Occupying the front of the electrocardiograph can greatly increase the screen-to-body ratio of the electrocardiograph; when collecting ECG signals in clinical practice, conductive paste or saline is often applied to the electrodes to reduce resistance and improve the reliability of ECG signal collection. Wristbands are used for collection For ECG signals, apply conductive paste or saline on the wristband to avoid potential damage to the electrocardiograph.
把心电图仪放入配套的手环腕带，当左手佩戴手环腕带，右手和手环腕带负极接触，就可以马上采集心电信号（I导联），主要是用于心律失常的即时监测。手环腕带也可以用于手持式多点检测法，右手握住手环腕带负极，环腕带正极和各个导联检测点相接触，采集多个导联心电图数据。把心电图仪放入配套的手环腕带，方便随身携带和随时随地行心电监测和心电图检查。Put the electrocardiograph into the matching wristband, when the left hand wears the wristband, and the right hand contacts the negative electrode of the wristband, the ECG signal (lead I) can be collected immediately, which is mainly used for the instant arrhythmia monitor. The wristband of the wristband can also be used for the handheld multi-point detection method. Hold the negative electrode of the wristband with the right hand, and the positive electrode of the wristband is in contact with the detection points of each lead to collect multiple lead ECG data. Put the electrocardiograph into the matching wristband, which is convenient to carry and perform ECG monitoring and ECG inspection anytime and anywhere.
心电图仪配套有心电图仪套，心电图仪套的心电图导联线可将导联线接收的信号传递到心电图仪；根据机器不同型号设定，可有2个或多个导联线用于多导联心电图检查和持续心电监测，持续心电监测时也可以和远程监护仪配合使用进行实时远程心电监护。根据不同采集心电图的方法其心电图图像有右手导联心电图系统和常规标准导联心电图系统2种。The electrocardiograph is equipped with an electrocardiograph cover, the ECG lead wire of the electrocardiograph cover can transmit the signal received by the lead wire to the electrocardiograph; according to the different model settings of the machine, there can be 2 or more lead wires for multi-lead Combined with ECG inspection and continuous ECG monitoring, it can also be used in conjunction with a remote monitor for real-time remote ECG monitoring during continuous ECG monitoring. According to different methods of collecting ECG, there are two types of ECG images: the right-hand lead ECG system and the conventional standard lead ECG system.
仅采用三条导联线就可以采集标准导联心电图。将3条导联线分别连接于右上肢、左上肢、左下肢或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，然后握住心电图仪套用心电图仪套正极分别接触各个胸导联检测点，用这种方法就可以采集标准导联心电图，而不是经过计算、推导的标准导联心电图。Standard lead ECG can be collected with only three lead wires. Connect the three lead wires to the right upper limb, left upper limb, left lower limb, or under the outer 1/3 of the clavicle on both sides, and the left anterior axillary line to the midpoint of the lower edge of the rib and the upper edge of the ilium, then hold the electrocardiograph and apply the electrocardiogram The positive pole of the instrument cover contacts the detection points of each chest lead separately. In this way, standard lead electrocardiograms can be collected instead of standard lead electrocardiograms that have been calculated and deduced.
该装置可用在个人自我心电图检查和心电监测、远程实时心电监护，也可以用在院前急救、院内救治、突发紧急医疗救援事件时心电图检查和心电监测、远程实时心电监护。该心电图仪可以让患者、医生平时随身携带并满足随时随地行心电监测和心电图检查的临床需求。The device can be used for personal self-ECG examination and ECG monitoring, remote real-time ECG monitoring, as well as pre-hospital first aid, in-hospital treatment, ECG examination and ECG monitoring during emergency medical rescue events, and remote real-time ECG monitoring. The electrocardiograph can be carried by patients and doctors and meet the clinical needs of ECG monitoring and ECG inspection anytime and anywhere.
图1 为该心电图仪和配套的手环腕带、心电图仪套的整体示意图，上面为心电图仪套，中间心电图仪，下面为手环腕带；Figure 1 is the overall schematic diagram of the electrocardiograph and the matching wristband and electrocardiograph cover. The upper is the electrocardiograph cover, the middle is the electrocardiograph, and the lower is the bracelet and wristband;
图2 为该心电图仪上面、正面、侧面视图；Figure 2 is the top, front and side views of the electrocardiograph;
图3 为该心电图仪侧面、背面、底面视图；Figure 3 is the side, back and bottom view of the electrocardiograph;
图4 为该手环腕带内侧面视图；Figure 4 is the inner side view of the wristband of the wristband;
图5为该心电图仪和心电图仪套示意图，上面为心电图仪，下面为带心电图导联线的心电图仪套；Figure 5 is a schematic diagram of the electrocardiograph and the electrocardiograph cover, the upper part is the electrocardiograph, and the lower part is the electrocardiograph cover with the ECG lead wire;
图6为带心电图导联线的心电图仪套示意图；Figure 6 is a schematic diagram of an electrocardiograph cover with an electrocardiogram lead wire;
图7心电图仪心电图导联连接端口为双导联线示意图；Figure 7 The electrocardiograph lead connection port of the electrocardiograph is a schematic diagram of a two-lead wire;
图8心电图仪心电图导联连接端口为三导联线示意图；Figure 8 The electrocardiogram lead connection port of the electrocardiograph is a schematic diagram of a three-lead wire;
图9心电图仪心电图导联连接端口为多导联线示意图；Figure 9 The electrocardiogram lead connection port of the electrocardiograph is a schematic diagram of a multi-lead wire;
图10常规心电图导联连接示意图；Figure 10 Schematic diagram of conventional ECG lead connection;
图中1.心电图仪的心电图模块正极、2.心电图仪的心电图模块负极、3. 心电图仪的心电图导联线连接端口、4. 心电图仪的USB端口、5.心电图仪的屏幕、6.手环腕带的心电图正极、7. 手环腕带的心电图负极、8. 多功能按键、9.心电图仪套的心电图正极、10.心电图仪套的心电图导联线连接端口、11.心电图仪套的多功能按键、12.导联线、13.心电图仪的心电图模块、14.心电信号处理和传输模块；P1~P9代表心电图导联连接端口的连接导联线触点、R代表电阻、-代表心电图负极、+代表心电图正极。In the figure 1. The positive electrode of the electrocardiograph module of the electrocardiograph, 2. The negative electrode of the electrocardiograph module of the electrocardiograph, 3. The connection port of the electrocardiogram lead wire of the electrocardiograph, 4. The USB port of the electrocardiograph, 5. The screen of the electrocardiograph, 6. The hand The positive electrode of the ECG of the wrist strap, 7. The negative electrode of the ECG of the wrist strap, 8. The multi-function button, 9. The positive electrode of the ECG of the electrocardiograph, 10. The connection port of the ECG lead of the electrocardiograph, 11. The electrocardiograph of the electrocardiograph The multi-function button, 12. Lead wire, 13. ECG module of the electrocardiograph, 14. ECG signal processing and transmission module; P1~P9 represent the contact of the lead wire of the ECG lead connection port, R represents the resistance, -Represents the negative electrode of the ECG, and + represents the positive electrode of the ECG.
当需要行心电图检查时，右手和检测点皮肤清洁后涂上导电膏或者生理盐水，右手握住心电图仪负极或者手环腕带负极，然后让心电图仪正极或者手环腕带正极和各个导联检测点相接触，记录可用于临床分析的右手导联心电图。When an electrocardiogram is required, clean the skin of the right hand and the detection point and apply conductive paste or saline. Hold the negative electrode of the electrocardiograph or the negative electrode of the wristband with the right hand, and then let the positive electrode of the electrocardiograph or the positive electrode of the wristband and each lead The detection points are in contact, and the right-hand lead electrocardiogram can be recorded for clinical analysis.
当需要行标准导联心电图检查时或者不紧急时，心电图仪套上心电图仪套，采用三导联线方案。将3条导联线分别连接于右上肢、左上肢、左下肢或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，然后由本人或者他人用心电图仪套底部正极分别和标准导联的V1 ~V6检测点相接触，用这种方法就可以采集标准导联心电图。When a standard-lead electrocardiogram is required or when it is not urgent, the electrocardiograph is put on the electrocardiograph cover, and the three-lead wire scheme is adopted. Connect the three lead wires to the right upper limb, left upper limb, left lower limb, or under the outer 1/3 of the bilateral clavicle, and the left anterior axillary line to the midpoint of the lower rib and upper edge of the ilium, and then use the electrocardiogram by yourself or others The positive pole at the bottom of the instrument case and the standard lead V1~V6 detection points are in contact, and standard lead ECG can be collected in this way.
当佩戴手环腕带需要即时监测心律失常的时候，左手佩戴手环腕带，右手和手环腕带负极接触，采集I导联心电信号。When you need to monitor arrhythmia in real time while wearing the wristband, wear the wristband with your left hand, and contact the negative electrode of the wristband with your right hand to collect the I-lead ECG signal.
当需要行持续心电监测的时候，把心电图仪装入心电图仪套，将各个导联线用一次性电极吸附予相应位置行心电监测，持续心电监测时也可以通过手机或者USB、蓝牙、WiFi、内置手机模块等和远程监护仪配合使用进行实时远程心电监护。When continuous ECG monitoring is needed, put the ECG into the ECG case, and attach each lead wire to the corresponding position with disposable electrodes for ECG monitoring. For continuous ECG monitoring, it can also be monitored via mobile phone, USB, Bluetooth , WiFi, built-in mobile phone module, etc., cooperate with the remote monitor for real-time remote ECG monitoring.
方式一：采用手持式多点检测法，右手和检测点皮肤清洁后涂上导电膏或者生理盐水，右手握住心电图仪负极，然后让心电图仪正极和各个导联检测点相接触，记录可用于临床分析的右手导联心电图。Method 1: Use the handheld multi-point detection method. Clean the skin of the right hand and the detection point and apply conductive paste or saline. Hold the negative electrode of the electrocardiograph with your right hand, and then contact the positive electrode of the electrocardiograph with the detection points of each lead. Recording can be used Clinically analyzed right-hand lead electrocardiogram.
方式二：当心电图仪装入手环腕带时，也可以采用手持式多点检测法：右手和检测点皮肤清洁后涂上导电膏或者生理盐水，右手握住手环腕带负极，然后分别让手环腕带正极和各个导联检测点相接触，记录可用于临床分析的右手导联心电图。Method 2: When the electrocardiograph is installed in the wristband of the wristband, the handheld multi-point detection method can also be used: clean the skin of the right hand and the detection point, apply conductive paste or saline, and hold the negative electrode of the wristband with your right hand, and then let them separately The positive electrode of the wristband of the wristband is in contact with the detection points of each lead, and the electrocardiogram of the right hand lead that can be used for clinical analysis is recorded.
方式三：当佩戴手环腕带需要即时监测心律失常的时候，左手佩戴手环腕带，右手和手环腕带负极接触，采集I导联心电信号。Method 3: When wearing the wristband and need to monitor the arrhythmia in real time, wear the wristband with the left hand and contact the negative electrode of the wristband with the right hand to collect the lead I ECG signal.
方式四：当心电图仪装入心电图仪套时，也可以将各个导联线接上肢体夹或者心电吸球或者一次性电极，然后行心电图检查。使用导联线行心电图检查具体方法依据导联线的不同分述如下：一、双导联线： 2条导联线分别对应心电图仪负极和正极。将负极导联线连接于右上肢或者右侧锁骨外1/3的下方，正极在各个导联检测点采集心电信号，记录右手导联心电图。二、三导联线：将3条导联线分别连接于右上肢、左上肢、左下肢或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，然后用心电图仪套正极分别在胸导联检测点采集心电信号，用这种方法就可以采集标准导联心电图，而不是经过计算、推导的标准导联心电图。用这种方法仅仅需要3条导联线就可以采集标准导联心电图，强烈推荐应用。三、多导联线：心电图导联连接端口可接多条导联线，这些导联线分别为相应肢导联和胸导联（图示为9个导联线，实际应用依据不同型号、功能设定不同导联线数量）。将肢导导联线分别连接于相应肢体或者双侧锁骨外1/3的下方、左腋前线于肋下缘和髂骨上缘中点，胸导连接在相应胸导联检测点。这个其实就是相当于普通心电图机采集心电图，但可能会存在成本高、机身比较庞大、耗电量大、导联线多、操作复杂等一系列问题，患者要随身携带心电图仪和行自我心电图检查、心电监测可能会比较困难。Method 4: When the electrocardiograph is installed in the electrocardiograph sleeve, you can also connect each lead wire to a limb clip or an ECG suction ball or a disposable electrode, and then perform an ECG examination. The specific methods of using the lead wire for ECG inspection are described as follows according to the different lead wires: 1. Double lead wire: The two lead wires correspond to the negative electrode and the positive electrode of the electrocardiograph respectively. Connect the negative lead to the right upper extremity or under the outer 1/3 of the right clavicle. The positive electrode collects the ECG signal at each lead detection point, and records the right hand lead ECG. Two- and three-lead wires: connect the three lead wires to the right upper limb, left upper limb, left lower limb, or below the outer 1/3 of the clavicle on both sides, and the left anterior axillary line at the midpoint of the lower rib and upper edge of the ilium, Then use the positive electrode of the electrocardiograph to collect the ECG signals at the chest lead detection points. In this way, the standard lead ECG can be collected instead of the calculated and deduced standard lead ECG. With this method, only 3 leads are needed to collect standard lead ECG, which is highly recommended. 3. Multi-lead wire: The ECG lead connection port can be connected to multiple lead wires. These lead wires are the corresponding limb leads and chest leads (the figure shows 9 lead wires. The actual application depends on different models, Function to set the number of different lead wires). Connect the limb leads to the corresponding limbs or below the outer 1/3 of the clavicle on both sides, the left anterior axillary line at the midpoint of the lower edge of the ribs and the upper edge of the iliac bone, and connect the chest leads to the detection points of the corresponding chest leads. This is actually equivalent to an ordinary electrocardiograph to collect an electrocardiogram, but there may be a series of problems such as high cost, relatively large body, large power consumption, multiple leads, and complicated operation. Patients should carry an electrocardiograph and take a self-electrocardiogram. Examination and ECG monitoring may be more difficult.
方式五-当心电图仪装入心电图仪套时，将各个导联线用一次性电极吸附予相应位置行心电监测，持续心电监测时也可以通过手机或者USB、蓝牙、WiFi、内置手机模块等和远程监护仪配合使用进行实时远程心电监护。用于持续心电监测时，如果患者出现明显胸痛、胸闷等症状，立即拿起心电图仪，切换到记录心电图模式，保持右上肢导联电极仍旧在右侧锁骨外1/3的下方，移动心电图仪到各个位点做出心电图。也可以干脆采用方式一或者方式二或者方式四进行多导联心电图采集（具体方案可心电图仪设定）。Method 5-When the electrocardiograph is installed in the electrocardiograph case, attach each lead wire to the corresponding position with disposable electrodes for ECG monitoring. During continuous ECG monitoring, it can also be monitored by mobile phone or USB, Bluetooth, WiFi, built-in mobile phone module It can be used in conjunction with a remote monitor for real-time remote ECG monitoring. When used for continuous ECG monitoring, if the patient has obvious chest pain, chest tightness and other symptoms, immediately pick up the electrocardiograph and switch to the ECG recording mode. Keep the right upper limb lead electrode still below the 1/3 of the right clavicle and move the ECG The electrocardiogram is made by the instrument to each site. You can also simply use method one or method two or method four for multi-lead ECG acquisition (the specific plan can be set by the electrocardiograph).
本发明不限定于上述特定的实施方案，而是扩展至所附的权利要求书的范围内的多种改型。本领域的技术人员应当理解，可以对本发明的技术方案进行修改或者等同替换，而不脱离本发明技术方案的精神和范围，其均应涵盖在本发明的权利要求范围当中。 The present invention is not limited to the specific embodiments described above, but extends to various modifications within the scope of the appended claims. Those skilled in the art should understand that modifications or equivalent replacements can be made to the technical solutions of the present invention without departing from the spirit and scope of the technical solutions of the present invention, which should all be covered by the scope of the claims of the present invention. To
目前市场上可穿戴/移动心电设备产品众多，比如带心电图功能的智能手表类、带心电图功能的智能手环、单导式心电仪等等众多类似产品，这些产品均具有心电图功能，并且均具有体积很小巧的特点，所以目前可穿戴/移动心电设备产品技术成熟，制作工艺没有问题。以目前的工艺将心电图模块集成到小型心电图仪是一件非常容易的事。目前可穿戴/移动心电设备绝大部分为单导联，可真正用于临床的产品仍处于空白，本发明采用手持式多点检测来解决上述技术问题，用仅仅2个电极的心电图仪做出可用于临床分析使用的多导联心电图（右手导联心电图）；该心电图（右手导联心电图）可以经计算推导出标准导联心电图；使用配套的心电图仪手环腕带可将该心电图仪当智能手环使用；使用配套的心电图仪套后该心电图仪可实现心电图检查、心电监测；持续心电监测时也可以通过蓝牙连接手机或者心电图仪内置的手机模块、WiFi等方式和远程监护仪配合使用进行实时远程心电监护。满足了临床上对随时随地行多导联心电图检查和心电监测、远程心电监护的需求，所以具有很好的应用前景。At present, there are many wearable/mobile ECG products on the market, such as smart watches with ECG function, smart bracelets with ECG function, single-lead electrocardiograph and many other similar products. These products all have ECG function, and Both have the characteristics of small size, so the current wearable/mobile ECG product technology is mature, and there is no problem with the production process. It is very easy to integrate the ECG module into a small electrocardiograph with the current technology. At present, most of the wearable/mobile ECG devices are single-lead, and the products that can be used in clinical practice are still blank. The present invention uses handheld multi-point detection to solve the above technical problems, and uses an electrocardiograph with only 2 electrodes. Produce a multi-lead electrocardiogram (right-hand lead electrocardiogram) that can be used for clinical analysis; this electrocardiogram (right-hand lead electrocardiogram) can be calculated to derive a standard lead electrocardiogram; use the matching electrocardiograph wristband to make the electrocardiograph When used as a smart bracelet; after using the supporting electrocardiograph cover, the electrocardiograph can realize electrocardiogram inspection and electrocardiogram monitoring; during continuous electrocardio monitoring, it can also be connected to the mobile phone or the built-in electrocardiograph via Bluetooth, WiFi and other methods and remote monitoring The instrument is used in conjunction with real-time remote ECG monitoring. It meets the clinical needs for multi-lead ECG examination, ECG monitoring, and remote ECG monitoring anytime and anywhere, so it has a good application prospect.
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/CN2019/104820WO2021046664A1 (en) | 2019-09-09 | 2019-09-09 | Handheld electrocardiograph for feasible multi-lead electrocardiogram examination |
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| PCT/CN2019/104820WO2021046664A1 (en) | 2019-09-09 | 2019-09-09 | Handheld electrocardiograph for feasible multi-lead electrocardiogram examination |
| Publication Number | Publication Date |
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| WO2021046664A1true WO2021046664A1 (en) | 2021-03-18 |
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/CN2019/104820CeasedWO2021046664A1 (en) | 2019-09-09 | 2019-09-09 | Handheld electrocardiograph for feasible multi-lead electrocardiogram examination |
| Country | Link |
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| WO (1) | WO2021046664A1 (en) |
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