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The smaller form factor allows the device of the present invention to be portable and readily carried in a pocket, wallet, handbag or other personal article.
Additionally, the wireless connection to a smart-phone enables direct reporting of data to a physician, hospital or data repository without the requirement docking with a computer, although it will be appreciated that in some embodiments the ECG device of the present invention will also be enabled to transmit data both wirelessly and via a wired connection, at the user's option. It should be understood that the detailed description and specific examples, while indicating the preferred embodiment of the invention, are intended for purposes of illustration only and are not intended to limit the scope of the invention.
In the description of embodiments of the invention disclosed herein, any reference to direction or orientation is merely intended for convenience of description and is not intended in any way to limit the scope of the present invention.
Relative terms such as "lower," "upper," "horizontal," "vertical," "above," "below," "up," "down," "top" and "bottom" as well as derivative thereof e. These relative terms are for convenience of description only and do not require that the apparatus be constructed or operated in a particular orientation unless explicitly indicated as such.
Terms such as "attached," "affixed," "connected," "coupled," "interconnected," and similar refer to a relationship wherein structures are secured or attached to one another either directly or indirectly through intervening structures, as well as both movable or rigid attachments or relationships, unless expressly described otherwise.
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Moreover, the features and benefits of the invention are illustrated by reference to the exemplified embodiments. Accordingly, the invention expressly should not be limited to such exemplary embodiments illustrating some possible non-limiting combination of features that may exist alone or in other combinations of features; the scope of the invention being defined by the claims appended hereto.
The monitoring device is a personal single lead electrocardiographic monitor for recording and storing real time ECG data for home health use and when transmitted can be processed and viewed by a remote data receiving device and or recipient.
The device of the present disclosure is intended for both home based ECG monitoring; when home based ECG monitoring is deemed beneficial by medical professionals or in a clinical setting. The present disclosure is also device intended for self-testing by adult users suitable for healthy people, who wish to develop a self-testing long term routine and for users, who already experience transient symptoms suggesting cardiac conduction abnormality,  The present disclosure also enables voluntary monitoring and also makes it possible for the results to be made available as reference for healthcare professionals, such as general practitioners.
The present disclosure enables both monitoring and self-monitoring as well as recording and is suitable for drug evaluation purposes; cardiac screening and ambulatory home based ECG monitoring. Significantly, the associated display device and software performs the processing of the raw data transmitted by the sensor card. In this regard, data processing overhead is handled primarily, if not exclusively, by the smart-phone or other display device.
The data is transferred wireless to a mobile phone via the NFC -protocol, Bluetooth or other short range wireless data transmission protocols.
The raw ECG samples are processed and analysed by the mobile software. It will be understood that the electronics are embedded on or integrally formed on a printed circuit board including all of the key electronic components all of which will typically be encased in a plastic housing having approximately same peripheral dimensions of a conventional credit card or larger depending on the internal electronics.
The electrodes may be fabricated with layers of electro-conductive materials including but not limited to conductive adhesives, conductive rubber or foam with an optional metal coating. For lowest cost implemented as etched conductive metal e. In order to reduce the electrical contact impedance to the skin, an electrolytic solution e.
The flexibility of the rubber increase contact area as because of the adaption to the skin structure.
WO2013155196A2 - Ecard ecg monitor - Google Patents
The flexibility also stabilizes the impedance during movements or tremors of the users fingers as the contact area between finger and electrode is more constant compared to the rigid metal plates. The flexible patches can be realized by conductive rubber or foam only. Alternatively, a layer of conductive rubber or foam coated with a very thin layer micro-meters of metal can be used.
The connection to the PCB is made via conductive adhesives and etched metal plates,  In one embodiment the system of the present disclosure comprises an ECG recording device in generally flat, planar credit card sized format and separate application, typically via a smart phone mobile for data processing, analysis, display and reporting.
That is, the electrical changes which are caused by heart muscle activity are measured via the skin. Instead of using electrodes connected to chest and extremities, a user connects to the electrode by placing the thumbs on two electrode patch areas integrated on the card.
Referring to standard ECG terminology, a single lead measurement setup is achieved. Typically, the signal is sampled at Hz for 30 sees. The memory is read out from the device via the wireless interface. In other words, the sensor device is a basic ECG electrodes sampling device with wireless data reporting means. The processing device processes the data, stores and displays the results.
One such method would be to place each thumb pad on the two electrode patch areas integrated on the upper surface of the card while simultaneously placing the one pair i. This arrangement ensures that there is a greater likelihood of contact sufficient to sample and measure ECG voltages.
A green LED embedded on the card surface indicates sampling is in progress. A red LED embedded on the card will light if a reading error occurred. Optionally, the visual LED indicators can be accompanied by an audible signalling device to alert the user of the operational status of the ECG card during the reading phase of operation. The ECG voltage signal is sampled for 30 seconds and stored to the cards memory.
When the measurement is completed, the sample data is transferred via wireless transmission such as Bluetooth or NFC to a smart- phone having software for processing and displaying the ECG data. Alternate ways to activate the device can also be employed.
It may be possible for the user to activate the device through a push-button or properly from gripping the electrodes for a sustained period of time.
At the time of activation the red LED will light up. During the data acquisition the green LED will light up indicating that sampling is in progress. An instrumentation amplifier is used to receive the small amplitude voltage signals generated by the heart muscle.
The amplifier provides a built-in amplification of from 5 to 10 times and has a large degree of common mode suppression. This noise is mostly common-mode noise which is suppressed by the instrumentation amplifier. The data is then validated and preliminarily analysed to confirm that the measured signals are sufficiently clean to make further analysis.
If the data read is un-usable, the user will be sent either a visual or audible signal to warn the user that second reading is necessary. The data qualification by the device may simply be a range check to make sure that the collected data was mostly within the measurement range of the ADC. The measured data is then transmitted for remote processing. An easy way to suppress this is to set the ADC data conversion frequency to a multiple of the power line frequency.
For example, by using a Hz data acquisition frequency, which is a multiple of both 50Hz and 60Hz, by averaging 6 data points when a 50Hz line frequency is present and 5 data points when a 60Hz line frequency is present, the power line interference is filtered out. This type of filtering may be done on the device or later after transfer to the mobile device or PC. The data is transferred wirelessly to a mobile phone, for example, via the NFC-protocol, Bluetooth or other similar wireless protocol.
It will be appreciated that the person being measured is holding electrodes PI and P2 with one hand and electrodes P3 and P4 with the other.
The signal is then fed into the amplifier. The analysis and calculation data generally proceeds using the following parameters.
WOA2 - Ecard ecg monitor - Google Patents
In the absence of the resistors the inputs would float and the output values would saturate. Final amplification and filtering  In an embodiment, the amplitude of the signal fed to the CPU ADC is preferably as close to the middle of the dynamic range of the ADC as possible to make the best use of the full dynamic range of the ADC. It therefore needs to be further amplified after the instrumentation amplifier and this is done using the circuit shown in Table 1 below.
Table 1 - Final amplification and filtering  Generally, the amplifier is a standard inverting amplifier with 43dB gain times with a first degree low pass filter. The -3dB cutoff frequency of the filter is Hz and helps to avoid unwanted signals being measured.
With the large amplification of the IC2: The principle is best demonstrated the simulation. Table 4 - Simulation schematic  A useful signal is simulated with a sine wave 6mV, 30Hz which is fed into the instrumentation amplifier. This signal appears on the output amplified 5 times centered around 1. A DC-offset of 3mV is then applied using the V2 after 50 ms.
The output then jumps up this offset amplified 5 times.
The output of the inverting integrator is then shown in the bottom graph. It started of at The output V mid first jumps down but is adjusted back after a while as the feedback output is increased. Table 5 - Feedback simulation  The output shall be maximum 1. The offset is therefore set to approximately 0.
Table 6 - Alternate implementation  Table 6 shows an alternate implementation of the ECG detection electronics. TP1 and TP2 are the electrodes that a user touches. This allows signals from the human heart beat to pass while providing a first filter stage to remove the higher frequency signals due to power line pickup.
Some of the higher frequency components of the heartbeat, such as the QRS complex, may be slightly attenuated, but this device main purpose is to measure statistics of the beat to beat interval, which occurs at a much lower frequency of 7Hz. It will be appreciated that it is also possible to change these values if desired.
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