Patent Publication Number: US-2022218256-A1

Title: Systems and methods for a personal medical monitoring device

Description:
CROSS REFERENCE TO RELATED APPLICATION 
     The non-provisional application claims priority to U.S. Provisional Application No. 63/135,565 filed Jan. 9, 2021, entitled “HEALTHYU, AN INTELLIGENT ALL-IN-ONE REMOTE PATIENT MONITOR WITH INTEGRATED ECG, STETHOSCOPE AND VITAL CLINICAL PARAMETERS”, which application is incorporated herein in its entirety by this reference. 
    
    
     BACKGROUND 
     The present invention relates in general to the field of medical devices and more specifically, to a personal device for cardiac and pulmonary monitoring and diagnosis. Such systems and methods are useful for assisting an individual to keep track of their health, and identify potentially dangerous pathologies before they become life threatening conditions. 
     Cardiac and pulmonary health is a major contributor to the overall health of a population. For example, according to the American Lung Association, just over six percent of the population suffers from Chronic Obstructive Pulmonary Disease (COPD), which is just a single lung pathology. Additionally, cardiac disease (particularly heart attacks and failures) is the leading cause of death in the United States, and costs society over $360 billion per year. 
     The ability to track cardiac and pulmonary disease (or per-disease states) can assist in reducing the rates of negative outcomes, and overall cost. Unfortunately, tracking cardiac functioning and lung activity typically takes specialized equipment not typically found outside a doctor&#39;s office. Further, interpretation of the results of these diagnostic tools usually requires a clinician. As such, an individual attempting to track their cardiac and/or pulmonary health needs to regularly see the doctor, which is costly, time consuming, and usually not feasible to do on as regular a basis as would be ideal. 
     Recently, more portable devices, aimed at in-home usage, have become available to consumers. These systems however generally suffer from sub-optimal resolution/sensitivity, poor analysis, and difficulty to use properly. 
     As such, the existing systems used for cardiac and/or pulmonary health classification are woefully inadequate for everyday usage, in-home, and without the need of a clinician present. It is therefore apparent that an urgent need exists for systems and methods for improved cardiac and/or pulmonary activity diagnosis in an easy-to-use device designed for personal use. Such systems and methods are designed to provide the user with improved visualization and diagnosis of potentially life-threatening conditions. 
     SUMMARY 
     The present systems and methods relate to improving classification of cardiac and/or pulmonary activity with a personal, easy-to-use device. Such systems and methods enable improvements in the diagnosis of possible pathologies, as well as providing insights into the health and wellbeing of the user. 
     In some embodiments, the handheld medical device  160  includes a housing including a front and rear side. A diaphragm is located in the center of the rear side of the housing. Three rear electrodes, configured to collect electromagnetic signals from the chest region of a patient, are located in a semi-circular in shape that encircles the diaphragm on the rear side of the housing. Two front electrodes located on the front side of the housing collect signals from the left and right index fingers of the patient. A screen is located between the two front electrodes. 
     In some embodiments, the electrodes are brass plated in nickel, which are then gold plated to increase conductivity. The device may include a transmitter, in some cases a Bluetooth module, for coupling the medical device  160  to a user device. The user device includes an application that receives the signals, and performs analysis on them. In some embodiments, the chest electrodes may be labeled as electrode 1 (E1) electrode 2 (E2) and electrode 3 (E3). The front finger electrode are the left finger electrode (LA) and the right finger electrode (RA). These five inputs are used to calculate seven ECG channels. These are calculated as the first channel (CH1) is the generated by the LA minus RA (LA−RA). The second channel (CH2) consists of Electrode 2 minus RA (E2−RA). Channel 3 (CH3) is channel 2 minus channel 1 (CH2−CH1). Channel 4 (CH4) is the negative of channel 1 plus channel 2 divided by 2 (−(CH1+CH2)/2). Channel 5 (CH5) is channel 1 minus channel 2 divided by 2 (CH1−CH2/2). Channel 6 (CH6) is channel 2 minus channel 1 divided by 2 (CH2−CH1/2). Channel 7 (CH7) is Electrode 1 minus WTC (E1−WTC), where the WTC is the RA, LA and Electrode 2 signals added together and then divided by three ((RA+LA+E2)/3). 
     In addition to collecting the ECG signals, the device collects phonocardiogram (PCG) data from the diaphragm. Another microphone may pick up ambient noises to allow for noise cancellation. In some embodiments, the system may include an optical sensor and temperature sensor on the front side of the housing below the left and right electrodes. These sensors come in contact with the user&#39;s left and right middle fingers as the device is held to the chest, and collect data related to body temperature, blood oxygenation, pulse rate, blood pressure and glucose levels. Additionally, in some cases, there may be other sensors present, such as conductivity sensors and chemical sensors for collecting other physiological data (hormone levels for example). 
     The application on the user device may be coupled, in some embodiments, to a backend system via a network (generally the internet). This backend system may perform analysis on the collected data and may flag when there are identified issues or pathologies. When identified, the system may send an urgent alert to a clinician for review of the data, and if needed arrangement for the patient to come into a clinician&#39;s office, or in more urgent situations, directly to the hospital. 
     The backend system may rely upon basic rule-based analysis of signals to generate alerts or may leverage advanced machine learning algorithms in order to identify possible pathologies. In some embodiments, the application on the user device may perform some, or all, of this analysis when sufficient computing resources are available. In which case, the user device may directly engage with the clinician&#39;s system. 
     Note that the various features of the present invention described above may be practiced alone or in combination. These and other features of the present invention will be described in more detail below in the detailed description of the invention and in conjunction with the following figures. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In order that the present invention may be more clearly ascertained, some embodiments will now be described, by way of example, with reference to the accompanying drawings, in which: 
         FIG. 1  is an example block diagram of a system for cardiac and/or pulmonary monitoring, in accordance with some embodiment; 
         FIG. 2  is an example block diagram for the HealthyU medical device, in accordance with some embodiment; 
         FIGS. 3A-3E  are example illustrations of the HealthyU medical device exterior, in accordance with some embodiment; 
         FIG. 4A  is an illustration of an example process for the operation of the medical device within the cardiac and/or pulmonary monitoring system, in accordance with some embodiments; 
         FIG. 4B  is an illustration of an example process device initialization, in accordance with some embodiments; 
         FIG. 5  is an illustration of example ECG and PCG waveforms, in accordance with some embodiments; 
         FIG. 6  is an illustration of an example screenshot of the HealthyU device 7-channel recorded ECG waveforms, in accordance with some embodiments; 
         FIG. 7  is an illustration of an example screenshot of the HealthyU device recorded ECG and PCG waveforms, in accordance with some embodiments; 
         FIG. 8  is an illustration of an example screenshot of the HealthyU device first three channel recorded ECG waveforms, in accordance with some embodiments; 
         FIG. 9  is an illustration of an example screenshot of the HealthyU preview screen, in accordance with some embodiments; 
         FIG. 10  is an illustration of an example screenshot of the HealthyU device positioning and body posture, in accordance with some embodiments; 
         FIGS. 11-13  are illustrations of example screenshots of the HealthyU device settings screen, in accordance with some embodiments; 
         FIG. 14  is an illustration of an ECG waveform, in accordance with some embodiments; 
         FIG. 15  is an illustration of example HealthyU device positioning, in accordance with some embodiments; 
         FIGS. 16A and 16B  are illustrations of computer systems capable of the backend diagnostic and analysis activity of the medical device system, in accordance with some embodiments; 
         FIGS. 17A and 17B  provide renderings of the medical device screen, in accordance with some embodiments; 
         FIG. 18  provides a rendering of the battery level icons, in accordance with some embodiments; 
         FIG. 19  provides a rendering of the pairing screen of the application on the user device, in accordance with some embodiments; 
         FIG. 20  provides an example process of timer  2  operation, in accordance with some embodiments; 
         FIG. 21  provides an example process of timer  3  operation, in accordance with some embodiments; 
         FIG. 22  provides an example process of timer  4  operation, in accordance with some embodiments; 
         FIG. 23  provides an example process of timer updating, in accordance with some embodiments; 
         FIG. 24  provides an example process of battery management, in accordance with some embodiments; 
         FIG. 25  provides an example process of battery indication, in accordance with some embodiments; 
         FIG. 26  provides an example process of timer, firmware and battery updates, in accordance with some embodiments; 
         FIG. 27  provides an example process of signal acquisition, in accordance with some embodiments; 
         FIG. 28  provides an example process of initialization of the medical device  160 , in accordance with some embodiments; 
         FIG. 29  provides an example process of ECG and PCG sampling, in accordance with some embodiments; 
         FIG. 30  provides an example process of medical device and user device pairing, in accordance with some embodiments; 
         FIG. 31  provides a rendering of a first version of a paired screen of the medical device, in accordance with some embodiments; 
         FIG. 32  provides a rendering of a second version of a paired screen of the medical device, in accordance with some embodiments; 
         FIG. 33  provides a rendering of a patient file management screen of the application on the user device, in accordance with some embodiments; 
         FIG. 34  provides a rendering of a patient file screen of the application on the user device, in accordance with some embodiments; 
         FIG. 35  provides a rendering of the top portion of a patient record screen of the application on the user device, in accordance with some embodiments; 
         FIG. 36  provides a rendering of the bottom portion of a patient record screen of the application on the user device, in accordance with some embodiments; and 
         FIG. 37  provides an illustration of the circuit diagram for the medical device  160 , in accordance with some embodiments. 
     
    
    
     DETAILED DESCRIPTION 
     The present invention will now be described in detail with reference to several embodiments thereof as illustrated in the accompanying drawings. In the following description, numerous specific details are set forth in order to provide a thorough understanding of embodiments of the present invention. It will be apparent, however, to one skilled in the art, that embodiments may be practiced without some or all of these specific details. In other instances, well known process steps and/or structures have not been described in detail in order to not unnecessarily obscure the present invention. The features and advantages of embodiments may be better understood with reference to the drawings and discussions that follow. 
     Aspects, features and advantages of exemplary embodiments of the present invention will become better understood with regard to the following description in connection with the accompanying drawing(s). It should be apparent to those skilled in the art that the described embodiments of the present invention provided herein are illustrative only and not limiting, having been presented by way of example only. All features disclosed in this description may be replaced by alternative features serving the same or similar purpose, unless expressly stated otherwise. Therefore, numerous other embodiments of the modifications thereof are contemplated as falling within the scope of the present invention as defined herein and equivalents thereto. Hence, use of absolute and/or sequential terms, such as, for example, “always,” “only,” “will,” “will not,” “shall,” “shall not,” “must,” “must not,” “first,” “initially,” “next,” “subsequently,” “before,” “after,” “lastly,” and “finally,” are not meant to limit the scope of the present invention as the embodiments disclosed herein are merely exemplary. 
     The present invention relates to systems and methods for the monitoring of pulmonary and/or cardiac health. In particular, cardiac health is focused upon. It should be noted however that the medical device  160  may include many additional sensory capabilities that allow for complex and varied medical diagnoses that expand well beyond mere cardiac functioning. Thus, while this disclosure may center upon cardiac (and to a lesser degree pulmonary) activity, it is not intended to limit the scope of this disclosure or the functioning of the instant device to only monitor and analyze these particular fields of medicine. 
     General Description 
     To facilitate discussions,  FIG. 1  is an example medical monitoring system, shown generally at  100 . In this example system a medical device  160  (also referred to as the HealthyU device) is coupled to a larger system via a network. The medical device  160  collects physiological data from a user (not illustrated). In some embodiments, the medical device  160  is a home healthcare electronic multiparameter system for patients&#39; ≥10 Kg to capture, record and replay heart sounds (PCG) and electrocardiogram (ECG) rhythm. It is to be used by one patient at a time. Heart sounds (PCG) and 7-channel ECG rhythm are acquired and displayed simultaneously on an accompanying application software on a hand-held smart device  170 . The waveforms can be recorded and sent to their clinician. The medical device  160  is a homecare device for use by lay operator, or clinician for tracking health parameters. 
     A user device  170  may connect to the medical device  160  either directly via a Bluetooth (or similar) connection, or via the network  130 . The user device  170  may comprise a tablet, smartphone, computer, or virtually any device with a screen interface and some computational capacity. 
     Similarly, the medical device  160  may couple to one or more peripheral sensors  120   a - x . This connectivity (when the peripheral device is present) may likewise be through the network  130  or direct through a Bluetooth or similar connection (not illustrated). The medical device  160  may also couple to a backend server  140  via the network  130 . Since the medical device  160  is generally a relatively ‘light weight’ device, the backend server  140  allows for much deeper AI analysis of the collected physiological data, as well as providing connectivity for clinicians for review of the collected data (not illustrated). The backend server  140  includes data stores  150  for saving the collected medical data. 
     In most cases the network is comprised of a cellular network and/or the internet. However, it is envisioned that the network includes any wide area network (WAN) architecture, including private WAN&#39;s, or private local area networks (LANs) in conjunction with private or public WANs. 
     Turning to  FIG. 2 , a more detailed view of the medical device  160 . The heart of the medical device  160  includes a microcontroller unit  230  which couples the other elements of the medical device  160  together, and provides the local processing of collected data. The microcontroller  230  may include or couple to a local memory (not illustrated) for maintaining user settings and caching of the collected data. 
     In some particular embodiments, the microcontroller is a flash microcontroller based on the high performance 32-bit ARM Cortex-M3 RISC processor. It operates at a maximum speed of 84 MHz and features up to 512 Kbytes of Flash and up to 100 Kbytes of SRAM. The peripheral set includes a Highspeed USB Host and Device port with embedded transceiver, an Ethernet MAC, 2 CANs, a Highspeed MCI for SDIO/SD/MMC, an External Bus Interface with NAND Flash Controller (NFC), 5 UARTs, 2 TWIs, 4 SPIs, as well as a PWM timer, 3-channel general-purpose 32-bit timers, a low-power RTC, a low power RTT, 256-bit General Purpose Backup Registers, a 12-bit ADC. Features of one embodiment of the microcontroller are found in Table 1: 
     
       
         
           
               
             
               
                 TABLE 1 
               
             
            
               
                   
               
               
                 Microcontroller Features 
               
            
           
           
               
               
            
               
                 FEATURES 
                 MICROCONTROLLER 
               
               
                   
               
               
                 Flash 
                 2 × 256 Kbytes 
               
               
                 SRAM 
                 64 + 32 Kbytes 
               
               
                 Package 
                 LQFP144, LFBGA144 
               
               
                 Number of PIOs 
                 103 
               
               
                 EMAC 
                 MII/RMII 
               
               
                 External Bus Interface 
                 16-bit data, 8 chip selects, 23-bit address 
               
               
                 12-bit ADC 
                 16 ch  
               
               
                 12-bit DAC 
                 2 ch 
               
               
                 USART/UART 
                 3/2 
               
               
                 SPI (Serial Peripheral 
                 1 SPI controller, 4 chip selects + 
               
               
                 Interface) 
                 3 USART with SPI mode 
               
               
                 32-bit Timer 
                 9 ch 
               
               
                   
               
            
           
         
       
     
     The microcontroller architecture is specifically designed to sustain high-speed data transfers. It includes a multi-layer bus matrix as well as multiple SRAM banks, PDC and DMA channels that enable it to run tasks in parallel and maximize data throughput. The device operates at 3.3V and is available in 144-lead LQFP, LFBGA packages. In other embodiments, the user device may include the memory needed to store these pieces of information. An LCD or other display type that is driven by the microcontroller  230  is present on the device surface. The display allows the medical device  160  to provide battery indications, pairing instructions, and even collected signal data. 
     The microcontroller  230  can provided outbound audio via an amplifier  215  coupled to an audio jack  210 . A transceiver  235  allows the medical device  160  to connect to the user device directly, or through the network. In some embodiments, the medical device  160  is incapable of direct connectivity with the network, in these situations, the medical device  160  couples directly with the user device (by Bluetooth or similar protocol) and the user device in turn provides connection to the internet or cellular network. 
     The medical device  160  also includes one or more microphones  220 , which couples to the microcontroller  230  via a microphone controller  225 . The microphone controller  225 , when coupled to multiple microphones, may allow for directional or doppler type of analysis. Phonocardiogram or PCG is the recording of all the sounds made by the heart during a cardiac cycle. It is a plot of high-fidelity recording of the heart sounds and made by the heart. Additionally, a secondary microphone may be utilized to recognize ambient noise for the purposes of noise cancelation. 
     ECG sensors and buffers  245  couple to the ECG analog front end  250 . In some embodiments there are five ECG sensor pads. The medical device  160  incorporates all features commonly required in portable, low-power medical, sports, and fitness electrocardiogram (ECG) applications. With high levels of integration and exceptional performance, the medical device  160  enables the creation of scalable medical instrumentation systems at significantly reduced size, power and overall cost. 
     A battery complex 260 includes a rechargeable Lithium Polymer battery, which is used for powering the medical device  160 . In some specific embodiment, the battery nominal voltage is 3.7V. The power supply controller  265  controls the power supplies of the processor and peripherals via Voltage regulator control. In some specific embodiment, the power controller has its own reset circuitry and is clocked by the 32 kHz slow clock generator. The reset circuitry is based on a zero-power power-on reset cell. The zero-power power-on reset allows the power controller to start properly. 
     In some embodiments, the power controller is a low-noise, linear regulators that deliver up to 500 mA of output current with only 10.5 μVRMS of output noise from 10 Hz to 100 kHz. These regulators maintain ±1% output accuracy over a wide input voltage range, requiring only 100 mV of input-to-output headroom at full load. The 365 μA no-load supply current is independent of dropout voltage. It includes the programmable output soft-start rate, output overcurrent, and thermal overload protection. 
     A tactile transducer  240  provides vibration or other tactile output to the user. For example, once a sufficient sampling for the ECG or PCG is collected, the user may be notified by a slight vibration of the device. 
       FIGS. 3A to 3E  provide illustrations of the device  160  from the front, back and side, respectively. In  FIG. 3A , the first two ECG electrodes are seen  310  and  320 . These include left and right index finger pads which collect the left arm (LA) and right arm (RA) signals, respectively. The device may also include a screen, additional finger rests, power button, and other convenience features (such as a lanyard hook or the like). On the rear side of the device, shown at  FIG. 3B , the chest placement ECG sensors are seen (E1, E2 and E3)  380 A-C respectively. These three electrodes operate with the LA and RA signals to generate the seven channel ECG analysis. One or more diaphragms  370  collect the chest sound waves. On  FIGS. 3C and 3E , the connectivity ports for the device are seen. These may include a charging port (which may also be a data transfer port, in some embodiments), heart sound outputs (audio jack), and a charge indicator. On  FIG. 3D , the enhanced screen  340  content is seen. This includes where the blood oxygenation, heart rate, battery, time, and blood pressure being displayed. This version of the medical device  160  also includes the front right arm electrode  310  and left arm electrode  320 , as well as an optical sensor  350  for collecting the pulse rate, oxygenation, and blood pressure. A secondary sensor  360  includes an array of sensors, including at least one of a temperature sensor, chemical sensors, and conductivity sensor. The power button  330  can also be seen. On  FIG. 3E , the diaphragm  370  is seen centrally located, surrounded by semicircular chest electrodes  380 A-C. 
     Turning now to  FIG. 4A , an example process for the operation of the medical monitoring system is provided, seen generally at  400 . In this example process, the devices are initialized (at  410 ).  FIG. 4B  provides this initialization process in greater detail. Firstly, the internal peripherals are initialized (at  411 ). For example, when the system is powered on, it can initialize the ports, pins and interfaces. Likewise, the external peripherals, if present, are initialized (at  412 ). 
     The timer for ECG and PCG data capture are likewise initialized (at  413 ). Clock inputs may include a Low Power 32.768 KHz Slow Clock Oscillator with bypass mode, a low power RC oscillator, a 3 to 20 MHz Crystal or Ceramic Resonator-based Oscillator, which can be bypassed, a 480 MHz UTMI PLL, providing a clock for the USB High Speed Controller, and a 96 to 192 MHz programmable PLL (input from 8 to 16 MHz), capable of providing the clock MCK to the processor and to the peripherals. A Watchdog Timer can be used to prevent system lock-up if the software becomes trapped in a deadlock. It features a 12-bit down counter that allows a watchdog period of up to 16 seconds (slow clock at 32 kHz). It can generate a general reset or a processor reset only. In addition, it can be stopped while the processor is in debug mode or idle mode. The reset time of watchdog timer is 1 sec. It can continuously monitor the microcontroller program, to update the ECG or PCG data as per data protocol format and sends to Bluetooth low energy when it is formatted. 
     Next, a free RTOS task is created (at  414 ), and the system loops (at  415 ). Free RTOS is a real time scheduler for microcontroller applications to meet their hard real-time requirements. It allows microcontroller applications to be organized as a collection of independent tasks to be executed based on priority. The functions of Free RTOS make the round robin in the case of tasks with the same priority. 
     Returning to  FIG. 4A , after device initialization, the medical device  160  is paired (at  420 ) with the user device  170 . As discussed previously, this may be a direct Bluetooth (or equivalent) connection, or a connection via the network. 
     The user is then given a series of instructions about positioning of the medical device  160 . The medical device  160  is thus positioned against the user&#39;s chest in various positions. The three backside electrodes contact the skin, and with the inputs from the LA and RA sensors, generate the seven channels for the ECG. If there is not a proper signal(s) being collected (at  440 ) the user is prompted to reposition the device, and collect additional signals (at  450 ). A decision is then made if additional inputs are needed (at  455 ). These additional inputs typically include sound collection (for PCG and pulmonary analysis), temperature and optical sensory data (for blood pressure, oxygen sensory purposes, blood pressure, glucose levels, red blood cell counts, and corroboration of pulse). In some embodiments, the device may include even more inputs, including skin conductivity measurements, and chemical analysis. Once these additional signals are collected (at  460 ), the signal analysis occurs (at  470 ). In some alternate embodiments, the various sensors, including the optical sensor, may be co-located with the index finger electrodes. In some embodiments, this allows for four distinct measurement locations (two at top locates with the electrodes, and two at the bottom finger placement locations). Having multiple sensors allows for redundancy if the signal is poor from another sensor (such as by poor finger placement), and allows averaging of signals to improve accuracy. 
     In the 5-Lead ECG shown in  FIGS. 3A-3C , the medical device  160  uses a Common-Mode Detector to measure the common-mode of the system by averaging three voltage of input pins, and uses this signal in the right-leg drive feedback circuit. A Wilson Central Terminal is generated by the medical device  160  and is used as a reference to measure the chest electrode. The chip uses an external 4.096 MHz crystal oscillator to create the clock source for the device. The ECG signals are captured using 5 electrodes placed on circular board. Three circular shape electrodes Projected on Chest side and two finger electrode placed on display side to pick the ECG. The 5 electrodes are brass plated with nickel and then gold plated to increase conductivity. A high pass filter rectifies the signal capture by electrodes and a filtering circuit filters the signal and send it through SPI channel for digital signal processing. The five leads are used to generate a seven channel ECG signal. Using  FIGS. 3A and 3B  as a reference, the first channel (CH1) is the generated by the LA minus RA (LA−RA). The second channel (CH2) consists of Electrode 2 minus RA (E2−RA). Channel 3 (CH3) is channel 2 minus channel 1 (CH2−CH1). Channel 4 (CH4) is the negative of channel 1 plus channel 2 divided by 2 (−(CH1+CH2)/2). Channel 5 (CH5) is channel 1 minus channel 2 divided by 2 (CH1−CH2/2). Channel 6 (CH6) is channel 2 minus channel 1 divided by 2 (CH2−CH1/2). Channel 7 (CH7) is Electrode 1 minus WTC (E1−WTC), where the WTC is the RA, LA and Electrode 2 signals added together and then divided by three ((RA+LA+E2)/3). The placement of electrodes in human body, while diagnosing is very important for getting a good ECG signal. Electrode location is shown generally at  1000  of  FIG. 10 . 
     For reference, an example ECG sample is provided for informational purposes, seen at  1400  of  FIG. 14 . The P-wave is generally less than or equal to 0.11 seconds, the PR interval is between 0.12 to 0.20 seconds. The QRS complex is less than or equal to 0.12 seconds. The amplitude of this wave should be between 0.5 mV and 3.0 mV. The ST segment is between 0.08 and 0.12 seconds. Lastly, the QT interval is less than or equal to 0.4 seconds for males, and 0.44 for females. The regular sinus rhythm is between 60-100 beats per minute. Any parameters measured that are substantially outside these ranges are flagged by the system for analysis by a clinician or via an AI analyzer. Substantially outside the range, may include values that are greater than one, two or three standard deviations from these normative values. 
     In addition to the ECG signal processing, a phonocardiogram (PCG) signal is likewise acquired. A phonocardiogram (or PCG) is the recording of all the sounds made by the heart during a cardiac cycle. It is a plot of high-fidelity recording of the sounds made by the heart. The heart sound is distinguished as two components: the first heart sound (S1) and the second heart sound (S2). S1 is due to closure of mitral and tricuspid valves which permit the flow of blood from atria into the ventricles. The duration of S1 is 50-100 msec, with a frequency of 30-45 Hz. S1 also has a greater amplitude than S2. The S1 is best heard at the apex of mid pericardium. The S2 occurs at the end of ventricular systole due to closure of semilunar valves (aortic and pulmonary aortic valves) in the arteries leading out of the ventricles. S2 has a duration of 25-50 msec, and a frequency of 50-70 Hz. S2 is best heard in the aortic and pulmonary areas. 
     In some embodiments, the main microphone is a diaphragm. The microphone is a PVC sleeve with a polycarbonate diaphragm. The microphone input is sent to a printed circuit board (PCB) analog front end (AFE). This PCB AFE is a low-power rail-to-rail input/output operational amplifier specifically designed for portable applications. The input common-mode voltage range extends beyond the supply rails for maximum dynamic range in low-voltage systems. The amplifier output has rail-to-rail performance with high-output-drive capability, solving one of the limitations of older rail-to-rail input/output operational amplifiers. This rail-to-rail dynamic range and high output drive make the PCB AFE ideal for buffering analog-to-digital converters. The operational amplifier has 6.4 MHz of bandwidth and 1.6 V/μs of slew rate with only 500 μA of supply current, providing good ac performance with low power consumption. Three members of the family offer a shutdown terminal, which places the amplifier in an ultralow supply current mode (IDD=0.3 μA/ch). While in shutdown, the operational-amplifier output is placed in a high-impedance state. DC applications are also well served with an input noise voltage of 11 nV/✓Hz and input offset voltage of 100 μV. 
     The PCB AFE is then coupled to an audio amplifier  215  which, in some embodiments, is a mono bridged audio power amplifier capable of delivering power into a 3Ω load with less than 10% THD. A secondary microphone provides signal of ambient noise in order to allow for noise cancellation. 
     Returning to  FIG. 4A , after signal analysis, a determination is made whether a pathology has been detected or not (at  475 ). This pathology detection process may be as simple as detection of any ECG, PCG, heart rate, temperature, blood pressure, or other detected signal outside of a normative value. Alternatively, more complex algorithms designed for detection of pathologies may be employed. In some embodiments, this can also include leveraging of AI models that have been trained on large datasets of normal and pathology signals. These may include deep neural networks. These pathology detection processes may occur in the medical device  160  itself, in the user device, but most commonly on the backend server. This stems from the enhanced processing capabilities of the backend system. 
     If a pathology is detected (or in some instances where the patient is in need of more regular monitoring) the data may be transferred to a clinician for review (at  480 ). Lastly, the output of the system may be presented (at  490 ) either on the user device itself, on the medial device, or made available via the cloud (in conjunction with the backend server). 
     The outputs may appear as a PCG and ECG signal, as seen at  500  of  FIG. 5 . In this example raw output, the PCG signal is illustrated on the top, and a single ECG signal is presented on the bottom. In another embodiment, all seven ECG signals may be presented to the clinician or user, as seen at  600  of  FIG. 6 . Here the 7-channel ECG waveform (limb leads, chest leads and augmented leads) are displayed simultaneously in this screen. 
       FIG. 7  illustrates another example signal output with a single PCG sample with a single ECG sample, shown generally at  700 . Here is user or clinician has the option of recording the signals, freezing a portion of the signal for greater analysis, or adding a study to the sample. Similarly,  FIG. 8  provides the first three ECG samples within the system&#39;s preview environment where it is possible to record samples, freeze them or add them to a study. 
     Once a set of samples is recorded for analysis, the data may become available on a screen such as the one found at  900  of  FIG. 9 . Here the sample may be edited, discarded when no longer needed and saved. The user may switch between available samples, and may exit at any time. 
       FIG. 10  provides a feedback screen where the user can select the position the medical device  160  was placed upon the body, as well as the position the user is in when using the device, shown generally at  1000 . This is particularly helpful due to the fact that different postures and placements all yield differing results, and may analyze for different possible signs of pathologies. This selection information is useful for the clinician, as well as for any pathology detection software, in their analysis. 
       FIG. 11  provides an example screenshot of the settings of the various ECG signals, seen generally at  1100 . Similarly, screen length and gains may be configured at a settings screen such as the one seen at  1200  of  FIG. 12 . A summary settings page, such as  1300  of  FIG. 13 , provides the ability to edit and pair devices, alter user and clinician profiles, alter recording times and the like. 
     Particular Embodiments 
     Now that the general description of device structure and capabilities have been disclosed, a particular set of embodiments shall be disclosed for illustrative purposes. It should be noted that the particular limited sets of embodiments detailed in this sub-section are for illustrative purposes only, and are not intended to artificially limit the scope of the invention. As such, terms such as “must”, “can&#39;t” “will” and other such limiting language, is intended to only apply to the one instant embodiment being contemplated. Such restrictions are not intended to expand to other embodiments which may have a scope significantly broader than the instant substantiation. 
     As noted, HealthyU is a handheld device capable of sensing ECG and PCG using 3 chest electrodes and 2 finger electrodes, positioned against the chest. The HealthyU application is connected to HealthyU device via Bluetooth communication. HealthyU application displays the ECG and PCG for user or clinician observation. HealthyU system essential performance includes successful pairing of HealthyU device and HealthyU application using Bluetooth communication. ECG and PCG are monitored and displayed over this wireless communication. HealthyU application can be installed in any smart device that meets the minimum requirements, including: Android 9 and above, 2 GB RAM, 8 GB ROM, Screen Resolution 1280×800, Bluetooth 5.0, BLE (Bluetooth Low Energy), Wi-Fi, Global Positioning System (GPS), and an audio jack. Wherever the term device and app is mentioned, it refers to HealthyU device and HealthyU app respectively. 
     In particular embodiments, the medical device  160  should not be used on patients with cardiac pacemakers, defibrillators or other electronic implanted or wearable devices. Not used as sole basis for medication or treatment decisions, and not used during defibrillation, it is not defibrillator proof. In alternate embodiments, the device may rather include defibrillator functions that allow for defibrillation when cessation of cardiac function is detected. 
     When using the device, standard procedures for device positioning should be followed. Device positioning information is available in this manual and HealthyU application software. HealthyU uses Bluetooth low energy wireless data link. The Bluetooth range may be reduced when objects (walls, furniture, people, etc.) are between the HealthyU device and a paired mobile device. To improve Bluetooth connection, reduce the distance and ensure a line of sight between Healthy and mobile device consisting of HealthyU application. 
     In some embodiments, the device shall not be used for diagnostic purposes without clinician&#39;s consultation, and federal law restricts this device to sale to or on the order of a physician. Failure to follow the directions given in this manual could result in damage to the device and/or possible injury to the user/patient. Failure to follow operating and maintenance instructions, listed in the manual could result in malfunction of the device. The device is not recommended for use in the presence of equipment producing strong electromagnetic radiation/Magnetic Resonance Imaging (MM) and stacked device environment as it may affect the device functionality. Do not place the device on wet surfaces. Allowing the chest piece diaphragm to come into contact with liquids may affect the device functionality. 
     The device is not intended to be used on open wounds. Do not use any sharp pointed tool to reset the device. Do not expose the battery to a flame or excessive heat, immerse in or expose to water, short the terminals or disassemble the battery as doing so could damage the battery cause fire, injury or environmental contamination. Do not place heavy object on the device. Use only HealthyU accessories listed in this manual. Usage of any other accessories along with HealthyU device can compromise safety of the user. No special training or qualification is required to use the device. The HealthyU has no serviceable parts and does not require calibration. Do not open the device or perform any services. Failure to follow care and maintenance recommendations given in this manual could result in damage to the internal components of the HealthyU. Do not expose the device to a magnetic resonance (MR) environment. Conductive parts of electrodes and associated connectors for Type BF Applied Parts, including the neutral electrode, should not contact other conductive parts including earth. 
     For operation, to switch the device ON, momentarily press the power button. Once the device is switched ON, the display may show the HD Medical logo followed by HealthyU® logo with firmware version number. To switch the device OFF, momentarily press the power button. The following functional screen seen at  1700 A and  1700 B of  FIGS. 17A and 17B , respectively, may be displayed after device initialization. In this screen, time in 12 hour format, PCG icon with text, ECG icon with text and Battery status icon are displayed. Once this initialization screen is displayed, the device is ready for use. 
     The battery level icon on the top right corner of the display screen indicates current battery charge level of the device. Stages of battery level icon are represented in  FIG. 18 , at  1800 . The device is powered with a rechargeable Li-Polymer battery. To charge the device, connect the USB cable into the device charging port and into the charger provided. While connecting USB cable, if the device is in ON the following occurs: 1) Charging icon as shown in  FIG. 18  is displayed, 2) Charging indicator may illuminate with amber color, and 3) “Do not use, while charging” message is displayed. Once the charger is connected, device displays warning message and automatically shuts itself down to disable device functionality and use. The medical device  160  cannot be used in charge mode. This protects user by preventing operation while it is connected to the AC power supply. Charging completion is checked by turning ON the device, the device displaying fully or 100% charged battery level icon as shown in  FIG. 18 , and the charging indicator LED is illuminate in green color. Li-Polymer batteries discharge continuously. The battery may be recharged periodically, at least every 3 to 4 months. This may ensure the battery doesn&#39;t fail prematurely. 
     ECG and PCG signals acquired by HealthyU device are displayed on the HealthyU application installed on the paired smart device. HealthyU application displays guidelines for device placement. Before proceeding with device placement, the HealthyU application on the user device should be paired with the HealthyU device. From the device placement till the completion of ECG &amp; PCG recording, Bluetooth of the smart device should be ON and both HealthyU device and HealthyU application should be paired. 
     For operation, the user is to assume sitting/standing/supine/side-supine posture for ECG and PCG monitoring. The device is then held in the following manner: 1) with the lanyard hook facing upward direction, 2) with the three chest electrodes contacting chest region of user, 3) with the finger electrodes facing away from the body, and 4) with the smart display facing away from the body. Next, the device is placed in direct skin contact with the user. The device is then placed in at least four positions, as shown at  1500 A,  1500 B,  1500 C and  1500 D of  FIG. 15 . HealthyU application start screen also displays device placement information. Throughout the recording time users should place both index fingers on the upper slots and both middle fingers on the lower slots. 
     To use the device, the user should open the HealthyU application on the smart device. Smart device is any device of the user that meets the hardware requirements provided in table 1 above. Examples of smart devices: Mobile Phone, Tablet or Laptop. Next the user should pair HealthyU device and HealthyU application via Bluetooth. After Bluetooth pairing of device and application, HealthyU application may take user to the device placement guidelines followed by Steth screen display. Place the device directly on any one of the placement positions given in  FIG. 15  for at least 10 seconds for heart sounds (PCG) and channel 2 electrocardiogram (ECG). Real time heart sounds (PCG) and channel 2 electrocardiogram (ECG) waveforms are displayed in the HealthyU application Steth Screen. Place the device directly on any one of the placement positions given in  FIG. 15  for at least 10 seconds for 7-channel electrocardiogram (ECG). Real time 7 channel ECG signals are displayed in the HealthyU application&#39;s 7-channel screen. Ensure the ECG, PCG signal are in sync and displayed on the app screen by choosing the Steth mode in the application. 
     To record ECG &amp; PCG, a RECORD button is present in both steth screen and 7-channel screen, which user has to manually select to initiate recording. Once recording duration is completed, user is taken to preview screen. In the preview screen, user can choose to SAVE or DISCARD the recorded ECG and PCG signals. Representation of Steth screen and 7-channel screen are given in  FIGS. 5 and 6  respectively. 
     Use only HDI diaphragm with the device. Use of non□HDI diaphragms can result in faulty audio and display and possible analysis irregularities in any future detection/screening algorithms. USB Type C connector to USB 4-Pin Type-A Male connector can be used to connect the device to the charger. Length is 1 meter. The battery charger Input: 100-240V AC, 50/60 Hz, and Output: 5.0V DC, 1000 mA. 
     In some embodiment, the technical specifications of the device are as found in Table 2, below: 
     
       
         
           
               
             
               
                 TABLE 2 
               
               
                   
               
               
                 Technical specifications 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
            
               
                 Display 
                 1.14″ IPS TFT-LCD Color, 135 × 240 Pixels, 
               
               
                 Battery 
                 Rechargeable Li-polymer battery 
               
               
                   
                 1200 mAh 3.7 V 
               
               
                   
                 5 hours of continuous operation, when fully 
               
               
                   
                 charged 
               
               
                 Required interval 
                 Battery cycle life is 300 charge cycles 
               
               
                 for replacement 
               
               
                 of battery 
               
               
                 Battery charge time 
                 3 Hours (with fully depleted battery) 
               
               
                 Charger 
                 Input: 100-240 V AC, 50/60 Hz; Output: 5.0 V 
               
               
                   
                 DC, 1000 mA. 
               
               
                 Operating 
                 5° C. to 45° C. 
               
               
                 temperatures 
               
               
                 Operating humidity 
                 10% to 95% relative humidity without 
               
               
                   
                 condensation 
               
               
                 Storage &amp; transport 
                 −25° C. to +70° C. 
               
               
                 temperature 
               
               
                 Storage &amp; transport 
                 10% to 90% relative humidity without 
               
               
                 humidity 
                 condensation 
               
               
                 Atmospheric pressure 
                 700 hPa to 1060 hPa 
               
               
                 Dimension 
               
               
                 Physical weight 
                 76 grams (approximate - including battery) 
               
               
                 Emission compliance 
                 CISPR 11, Group 1, Class B (Residential 
               
               
                   
                 environment) 
               
               
                 Immunity test level 
                 10 V/m 
               
               
                 Type of protection 
                 Internally powered class II ME equipment 
               
               
                 Degree of protection 
                 Type BF 
               
               
                 Mode of operation 
                 Continuous 
               
               
                 Enclosure Degree of 
                 IP55 
               
               
                 protection 
               
               
                 Biocompatibility 
                 Device is biocompatible per ISO 10993-1 
               
               
                 Applied part 
                 Chest electrodes, Finger electrodes including 
               
               
                   
                 rest slots, On/OFF button, PCG and diaphragm 
               
               
                   
               
            
           
         
       
     
     The user should clean and disinfect the electrodes, diaphragm and the body of the device between use, failure to do so may cause infections or allergies to patients. The chest piece diaphragm and electrodes should be disinfected after each use with an alcohol wipe followed by cleaning with a lint-free soft clean and dry cloth. To clean the device, use only a lint-free soft clean and dry cloth. Dry the device completely before use. Do not immerse or soak the device in water or any other form of liquid sterilant for cleaning. 
     To store the device, keep it in a dry location away from any extreme heat. It is advisable to place the device on a soft surface to avoid damage to the device in general and to the chest electrode side. Storage of device in device package may prevent damage. Built-in Li-Polymer battery may be used only for up to 2 years. Hence the device after 2 years of usage can be sent to manufacturer for battery replacement. Device contains Li-Polymer battery and electronic components; hence device should not be disposed as social waste. Device and its accessories need to be disposed according to electrical and electronic waste disposal guidelines of local regulation. Contact local authorities to dispose device, its parts and accessories. 
     Regarding the application itself, which is loaded on the user device, the HealthyU application connects to HealthyU device via Bluetooth communication to display, record and replay the ECG and PCG data captured by the HealthyU device. HealthyU application has two screens namely steth screen and 7-channel screen. Steth screen display single channel ECG and PCG, whereas 7-channel screen display all 7 ECG waveforms. The patient file from HealthyU app can be stored locally in user&#39;s smart device and can be shared to clinician. Data displayed on the app shall not be used for diagnostic purposes without clinician&#39;s consultation in some cases. In others, the system may include algorithmic detection of pathologies. No special training or qualification is required to use the application. HealthyU app screen might display personally identifiable user information, ensure app screen is not viewable to public, while using in public places. For security reasons, all data stored in smart device shall be deleted on the uninstallation of application. 
     Initially the user should download HealthyU app from the App Store on a compatible android user device. The user then opens the HealthyU app and follows the onscreen instructions to register the HealthyU device. During the first usage, HealthyU app seeks minimum permission required to ensure intended app performance. Click Allow to proceed further. Steth screen is the default landing screen. Click the Bluetooth icon on the steth screen to initiate app scanning the nearby HealthyU device. Click the HealthyU device machine id displayed on the screen to complete pairing. For successful pairing ensure that the smart device Bluetooth is ON, the HealthyU device is ON, and the distance between HealthyU device and smart device is within 10 meters. An example of the pairing screen may be found at  1900  of  FIG. 19 . On successful pairing the Bluetooth icon displays label as paired in blue color, the HealthyU device&#39;s firmware version is displayed on the app screen, and the HealthyU device&#39;s battery level is displayed on the app screen. 
     ECG and PCG waveform are displayed in 2 screens, namely steth screen and 7-channel screen,  FIGS. 7 and 8  respectively. Icon in the steth screen labeled as 7-channel and icon in 7-channel screen labeled as steth can be used to switch screens. PCG and channel −2 ECG waveform are displayed in steth screen, whereas 7-channel ECG waveforms are displayed in 7-channel screen. Click the record button to start recording the ECG and PCG waveforms. Before initiating recording refer to instruction for use of HealthyU device and follow the positioning guidelines displayed on screen to position the device on the chest as intended. Set the recoding duration using the settings icon available in the screen. Ensure that the smart device&#39;s battery level is above 50% before starting the recording. 
     Once the recording duration is completed, a preview screen appears. In the preview screen recorded ECG and PCG waveforms are displayed. You can either save or discard the recorded waveforms using the save and discard button. Save the recording to an existing patient profile or add a new patient profile, while saving the recorded waveform the body posture and device location should be entered, using the screen seen at  FIG. 10 . The saved data are compiled in PDF format and stored in the smart device. This file can be printed or shared over email communication, in this particular embodiment. For each recording one PDF file is generated. Recording and saving actions are specific to steth screen and 7-channel screen. Hence, recording and saving need to be done individually in each screen. 
     Click on the Open icon (appearing as a file folder) available on the app screen to access the patient files. Patient files are ECG/PCG recordings of users/patients that have been saved in the system. The user can refer to them, whenever needed, based on the following search parameters: Patient ID, Name of patient, and/or Patient/user mobile number. Once a patient match is obtained, based on the above parameters, all the recordings pertaining to that patient would be available. All relevant recordings would be listed along with the timestamp information. User can select the recording of his/her choice and view it in replay mode. While playback is active, all other buttons in the user interface shall be inactive. An example of a screen for accessing patient files can be found at  3300  of  FIG. 33 . 
     All recordings are stored in smart device. Recordings listed are searchable using user name, id or contact details. Individual recordings can be selected to view or share. Recordings can either be printed or shared over email. Patient file also has heart rate value indicated corresponding to each recording. Accuracy of heart rate measurement is ±5 beats per minute. Recordings that are stored in smart device are encrypted to ensure data privacy and security. However, data is not secured over email communication. 
     To access settings the user clicks on setting icon in either steth screen or 7-channel screen. User configurable settings are available in settings screen. As previously discussed,  FIGS. 11-13  provide screenshots of the settings screens. Setting include the following options: Select Color—User may be able to change the default colors for the Heart Sound (HS)/PCG and ECG waveform using this option; ECG rhythm Grid—The grid can be enabled for the EKG rhythm, using this option; Edit Patient&#39;s Profile—User can use this option to make changes to the current profile of a patient. Patient/user profile includes name, date of birth, gender, contact details and medical history; Edit Doctor&#39;s Profile—Clinician can use this option to make changes to the current profile. Clinician profile includes name, expertise, experience, registration id and location; Recording Duration—This option can help the user change the auscultation recording duration from the default of 10 seconds to 20 seconds or 30 seconds etc. to 120 seconds; HealthyU Device registration (email, location, registration code)—First time users are expected to register themselves with HD Medical, Inc. for patient database and customer service purpose; Default auto pairing of selected smart device—For simple and fast connection between user&#39;s smart device and HealthyU device, user can enable this option. Every time the smart device detects the previously paired and auto pairing enables HealthyU device, it may automatically get connected; Renaming ECG channel labels—Users as per clinician&#39;s recommendation have the option to modify the ECG channel names. This may be done for easy ECG reading based on their standard protocol. The following Table 3 provides an overview of all functions in the application: 
     
       
         
           
               
             
               
                 TABLE 3 
               
             
            
               
                   
               
               
                 Icons and Functions 
               
            
           
           
               
               
            
               
                 Icons 
                 Functionality 
               
               
                   
               
            
           
           
               
            
               
                 Steth Screen and 7-channel screen 
               
            
           
           
               
               
            
               
                 Record 
                 Initiate recording ECG and PCG waveform from the HealthyU device. 
               
               
                   
                 Steth screen and 7-channel screen has dedicated record buttons. 
               
               
                 Freeze 
                 To screen capture the data present in active screen 
               
               
                 Add Study 
                 HealthyU app can be used by more than one user by creating 
               
               
                   
                 individual user profile. Using Add Study button, user and the 
               
               
                   
                 recording can be mapped one to one. 
               
               
                 Exit Study 
                 Exit study option can be used to switch between user profiles. Select 
               
               
                   
                 the profile corresponding to current user. 
               
               
                 Bluetooth 
                 To pair HealthyU device with app 
               
               
                 Steth 
                 To view steth screen displaying PCG and Channel - 2 ECG waveform 
               
               
                 7-Channel 
                 To view 7-channel ECG waveform 
               
               
                 Open 
                 To view demo files and Patient file 
               
               
                 Setting 
                 To view the user configurable settings 
               
               
                 Device Spec 
                 To view the user&#39;s smart device specifications 
               
            
           
           
               
            
               
                 Preview Screen 
               
            
           
           
               
               
            
               
                 Save 
                 To save the recorded waveforms 
               
               
                 Discard 
                 To discard the recorded waveforms 
               
               
                 Previous 
                 Recorded waveforms are shown in multiple screens. Previous option 
               
               
                   
                 can be used to shift between the multiple screens 
               
               
                 Next 
                 Recorded waveforms are shown in multiple screens. Next option can 
               
               
                   
                 be used to shift between the multiple screens 
               
               
                 Edit 
                 Body posture and HealthyU device position can be edited 
               
               
                 Exit 
                 Active session can be exited 
               
            
           
           
               
            
               
                 Settings Screen 
               
            
           
           
               
               
            
               
                 Graph Line 
                 To change ECG waveform color 
               
               
                 Graph Background 
                 To change ECG waveform background color 
               
               
                 Graph Label 
                 To change ECG waveform label. Labels can be changed after 
               
               
                   
                 consultation with clinician. 
               
               
                 ECG Grid 
                 To remove or keep ECG graph in the background 
               
               
                 Gain 
                 It is used to adjust waveform display according to your smart device&#39;s 
               
               
                   
                 screen size and resolution. 
               
               
                 Screen Length 
                 It is used to vary the number of ECG and PCG cycles displayed per 
               
               
                   
                 screen. 
               
               
                 Edit Patient&#39;s Profile 
                 Add user information such as name, id, gender, age, contact details 
               
               
                   
                 and medical history. This information is mapped with ECG and PCG 
               
               
                   
                 recordings to enable clinician in diagnosis. 
               
               
                 Edit Doctor&#39;s Profile 
                 Add consulting doctor name, registered id, area of expertise and 
               
               
                   
                 experience 
               
               
                 Disable Auto Pairing 
                 By default auto pairing is enabled. App is capable of connecting 
               
               
                   
                 automatically with your HealthyU device based on the previous 
               
               
                   
                 pairing. 
               
               
                 10 MPA 
               
               
                 Recording Time 
                 Recording duration can be changed in multiples of 10 seconds. 
               
               
                   
                 Recoding duration range is 10 seconds to 120 seconds. 
               
               
                   
               
            
           
         
       
     
     Upon completion of each recording, the user may switch off the smart user device&#39;s Bluetooth connection, and close all patient files and the application window. The smart user device should be screened for virus attacks at least once in a month to ensure that the data stored in the smart device is not compromised. Use a recognized anti-virus scanning app from App store. The application is updated for security and performance reasons from HD Medical, Inc. team. For such updates, a pop up message may be displayed on the screen to seek permission. In such cases, please accept and install the update. 
     Some specifications for the medical device  160  are captured in Table 4 below: 
     
       
         
           
               
             
               
                 TABLE 4 
               
             
            
               
                   
               
               
                 Design Requirements 
               
            
           
           
               
               
               
            
               
                 PRD ID 
                 Specification 
                 Rationale/Reference 
               
               
                   
               
            
           
           
               
            
               
                 Functional Requirements 
               
            
           
           
               
               
               
            
               
                 PR0001 
                 Weighing less than 100 grams 
                 Easy for patient to handle the 
               
               
                   
                   
                 device 
               
               
                 PR0002 
                 Degree of protection against harmful 
                 For safe operation in the home 
               
               
                   
                 ingress of water and particulate matter: 
                 healthcare environment 
               
               
                   
                 IP55 or higher 
                 IEC 60601-1, Clause 6.3 
               
               
                   
                   
                 Protection against harmful 
               
               
                   
                   
                 ingress of water or particulate 
               
               
                   
                   
                 matter 
               
               
                   
                   
                 Method of testing per IEC 
               
               
                   
                   
                 60601-2-47, 201.11.6.5 Ingress 
               
               
                   
                   
                 of water or particulate matter 
               
               
                   
                   
                 into ME equipment &amp; ME 
               
               
                   
                   
                 systems, IEC 60601-1-11, 
               
               
                   
                   
                 8.3.1. 
               
               
                 PR0003 
                 Battery life - minimum 5 hours of 
                 Typical use is four 15 min 
               
               
                   
                 continuous operation between recharges 
                 sessions per day on a single 
               
               
                   
                   
                 charge. 
               
               
                 PR0004 
                 Rechargeable Lithium Polymer Battery; 
                 Provide power to HealthyU 
               
               
                   
                 nominal voltage 3.7 V 
                 device via field-replaceable 
               
               
                   
                   
                 and rechargeable battery 
               
               
                 PR0005 
                 USB type-C receptacle for connecting 
                 To charge the Healthy U 
               
               
                   
                 5 V battery charger 
                 battery 
               
               
                 PR0006 
                 Operating input voltage of charger is 100- 
                 To use in U.S. and EU Market 
               
               
                   
                 240 V 
               
               
                 PR0007 
                 Color LCD Display 
                 Durable 
               
               
                   
                 Display Format: 135 × 240 pixel 
                 Easily readable in wide 
               
               
                   
                 (RGB) 
                 lighting condition (100- 
               
               
                   
                 Dimensions (H × W): 17 mm × 30 mm 
                 1500 lx) 
               
               
                   
                 minimum 
                 Time Display 
               
               
                   
                 Active Area (H × W): 14 × 24 mm 
                 Low battery status 
               
               
                   
                 minimum 
                 indication 
               
               
                   
                 Interface mode: SPI 
               
               
                   
                 Colors: 65K 
               
               
                 PR0008 
                 Bluetooth communication 
                 HealthyU to communicate with 
               
               
                   
                 BLE V 5.0 
                 the application software 
               
               
                 PR0009 
                 Accuracy of signal reproduction 
                 Accuracy of signal 
               
               
                   
                   
                 reproduction, input signal in 
               
               
                   
                   
                 range ±5 mv varying at rate 
               
               
                   
                   
                 125 mV/s shall be reproduced 
               
               
                   
                   
                 with error ≤ ±20% of nominal 
               
               
                   
                   
                 value of the output or ±100 
               
               
                   
                   
                 μV, whichever is greater. 
               
               
                 PR0010 
                 ECG electrodes 
                 Allow device to obtain 7 
               
               
                   
                 ADS1293 module is used for ECG 
                 channel ECG signals from 3 
               
               
                   
                 3 circular electrodes on chest side 
                 chest electrodes and 2 finger 
               
               
                   
                 (back) of device 
                 electrodes 
               
               
                   
                 2 finger electrodes on display side 
               
               
                   
                 (front) of device 
               
               
                 PR0011 
                 PCG waveform of heart sounds 
                 Provide plot of high-fidelity 
               
               
                   
                   
                 recording 
               
               
                 PR0012 
                 Application software detects all 
                 Provide connectivity between 
               
               
                   
                 HealthyU devices within range of 
                 application software and 
               
               
                   
                 Bluetooth connectivity 
                 HealthyU device 
               
               
                 PR0013 
                 HealthyU devices listed by name &amp; 
                 Provide option for user to 
               
               
                   
                 associated MAC ID in application 
                 select their HealthyU device 
               
               
                   
                 software 
               
               
                 PR0014 
                 Audio jack 3.5 mm in HealthyU device to 
                 To allow user to directly listen 
               
               
                   
                 connect with user device such as laptop, 
                 to the PCG audio signal in real 
               
               
                   
                 tablet to hear PCG audio signal 
                 time 
               
               
                 PR0015 
                 Type BF applied part 
                 IEC 60601-1, 8.3 
               
               
                   
                   
                 Classification of applied parts, 
               
               
                   
                   
                 type BF applied part protection 
               
               
                   
                   
                 since device is intended to 
               
               
                   
                   
                 receive electrophysiological 
               
               
                   
                   
                 signals from patients 
               
               
                 PR0016 
                 No energy reduction of Defibrillation 
                 IEC 60601-1, 8.5.5.2 Energy 
               
               
                   
                   
                 reduction 
               
               
                 PR0017 
                 Second microphone sensor is available to 
               
               
                   
                 sense and to transfer the sound signals 
               
               
                   
                 captured in the device ambience to 
               
               
                   
                 HealthyU application software 
               
            
           
           
               
            
               
                 Firmware Requirements 
               
            
           
           
               
               
               
            
               
                 PR0101 
                 Communication between HealthyU 
                 Display and save ECG and 
               
               
                   
                 device and application software 
                 PCG real time waveform in 
               
               
                   
                   
                 devices like mobile, computer 
               
               
                   
                   
                 or tablet. The saved ECG &amp; 
               
               
                   
                   
                 PCG shall be printed and can 
               
               
                   
                   
                 be accessed by registered 
               
               
                   
                   
                 practitioner. 
               
               
                 PR0102 
                 Provide display functionality on 
                 Display real time information 
               
               
                   
                 HealthyU device LCD 
                 such as time 
               
               
                   
                   
                 IEC 60417 
               
               
                   
                   
                 Battery status indication, low 
               
               
                   
                   
                 battery icon blinks 
               
               
                   
                   
                 While USB is connected for 
               
               
                   
                   
                 charging, charging indication 
               
               
                   
                   
                 is displayed both in OFF 
               
               
                   
                   
                 screen &amp; ON screen 
               
               
                 PR0103 
                 Device button functionality 
                 Buttons to control the 
               
               
                   
                 Power ON/OFF button to switch on/off 
                 HealthyU device 
               
               
                   
                 the HealthyU device 
               
               
                 PR0104 
                 Encryption protocol 
                 AES-128 protocol 
               
               
                 PR0105 
                 ECG signal is represented by 16 bits and 
                 To increase signal fidelity 
               
               
                   
                 PCG signal is represented by 8 bits 
               
               
                 PR0106 
                 Provide power from charged battery 
                 Device is powered via 3.7 V 
               
               
                   
                   
                 rechargeable Lithium battery 
               
               
                 PR0107 
                 Charge battery via USB-connected 
                 Battery is recharged via USB- 
               
               
                   
                 charger 
                 connected charger 
               
               
                 PR0108 
                 Indicate correct battery status on device 
                 Allow user to be aware of 
               
               
                   
                 display 
                 battery life between charges 
               
               
                 PR0109 
                 Firmware version shall be displayed on 
                 Allow user to confirm the 
               
               
                   
                 the device display during start up 
                 firmware version 
               
               
                 PR0110 
                 Upgrade/update firmware via JTAG 
                 Allow for device firmware 
               
               
                   
                 cable connected to device 
                 updates by manufacturer 
               
               
                 PR0111 
                 Device is powered ON when ON/OFF 
                 Power ON/OFF functionality 
               
               
                   
                 switch is pressed 
               
               
                 PR0112 
                 Device is powered OFF when ON/OFF 
                 Power ON/OFF functionality 
               
               
                   
                 switch is pressed 
               
               
                 PR0113 
                 Ensure device does not turn on when 
                 Proper switch functionality 
               
               
                   
                 ON/OFF switch is pressed continuously 
               
               
                 PR0114 
                 Encryption of BLE wireless signals and 
                 AES-128 protocol 
               
               
                   
                 data 
               
               
                 PR0115 
                 Incorporate error control processes (bit 
                 Ensure data displayed on 
               
               
                   
                 error rate, packet loss, and signal-to- 
                 mobile app accurately 
               
               
                   
                 noise ratio) to ensure integrity of 
                 replicates the data obtained by 
               
               
                   
                 wireless transmitted data 
                 the device 
               
               
                 PR0116 
                 Initialize internal peripherals 
                 Allow microcontroller to 
               
               
                   
                   
                 communicate with external 
               
               
                   
                   
                 modules 
               
               
                 PR0117 
                 Watchdog timer to generate system reset 
                 Prevent system lockup if 
               
               
                   
                 or processor reset 
                 software is trapped in deadlock 
               
               
                 PR0118 
                 Incorporate Universal Asynchronous 
                 Support Bluetooth connectivity 
               
               
                   
                 Receive Transmit (UART) channel for 
               
               
                   
                 connection between microcontroller and 
               
               
                   
                 Bluetooth module 
               
               
                 PR0119 
                 Incorporate Smart/Auto Pairing for 
                 Allow user to connect device 
               
               
                   
                 connection of device to mobile app 
                 to mobile app in an easy and 
               
               
                   
                   
                 secure fashion 
               
               
                 PR0120 
                 Implement correct Bluetooth device 
                 Ensure user connects mobile 
               
               
                   
                 name 
                 app to correct HealthyU device 
               
               
                 PR0121 
                 Real time data streaming at 115200 bps 
                 Provide real time data 
               
               
                   
                 baud rate 
                 streaming with appropriate 
               
               
                   
                   
                 fidelity to HealthyU mobile 
               
               
                   
                   
                 app 
               
               
                 PR0122 
                 Include synchronization header byte for 
                 Provide real time data 
               
               
                   
                 Bluetooth data transmission 
                 streaming to HealthyU mobile 
               
               
                   
                   
                 app 
               
               
                 PR0123 
                 Verify synchronized ECG and PCG data 
                 Ensure synchronized data is 
               
               
                   
                 to be transmitted via Bluetooth 
                 transmitted to HealthyU 
               
               
                   
                   
                 mobile app 
               
               
                 PR0124 
                 Ensure correct firmware version is 
                 Allow mobile app to display 
               
               
                   
                 installed to transmit proper ECG signal 
                 correct ECG signal waveform 
               
               
                   
                 to mobile app for display 
               
               
                 PR0125 
                 Reproduce heart sounds at captured 
                 Ensure accurate heart sound 
               
               
                   
                 sampling rate 
                 data is captured and 
               
               
                   
                   
                 transmitted to HealthyU 
               
               
                   
                   
                 mobile app 
               
               
                 PR0126 
                 Ensure functionality of heart sound/PCG 
                 Heart sounds shall be audible 
               
               
                   
                 audio 
               
               
                 PR0127 
                 Ensure HealthyU display is visible under 
                 IEC 60601-1-11 Display shall 
               
               
                   
                 various lighting conditions (100-1500 lx) 
                 be visible without glare under 
               
               
                   
                   
                 all lighting conditions 
               
               
                 PR0128 
                 Ensure real time ECG &amp; PCG signal data 
                 Real time ECG &amp; PCG signals 
               
               
                   
                 is displayed on mobile app when device 
                 shall be displayed on mobile 
               
               
                   
                 is in use 
                 app when device is in use 
               
               
                 PR0129 
                 At any time one HealthyU device can be 
                 To achieve intended use 
               
               
                   
                 paired only with one application. 
               
               
                   
                 Application pairing with device is 
               
               
                   
                 controlled by token based authorization 
               
               
                 PR0130 
                 Encryption protocol AES-128 available 
                 To ensure user privacy and 
               
               
                   
                 in the Bluetooth low energy device 
                 information security 
               
               
                   
                 encrypts data from device &amp; decrypts the 
               
               
                   
                 same data by application that is defined 
               
               
                   
                 internally in the firmware &amp; software 
               
               
                   
                 algorithms for secure &amp; lossless data 
               
               
                   
                 transfer using Bluetooth technology. 
               
               
                 PR0131 
                 Software safety classification for device 
                 IEC 62304 clause 4.3; 
               
               
                   
                 firmware and software is class B related 
                 Guidance for software 
               
               
                   
                 to moderate risk for FDA 
                 contained in medical device 
               
               
                   
                   
                 160s 
               
               
                 PR0132 
                 Create software development plan (SDP) 
                 IEC 62304 clause 5.1 
               
               
                   
                 for device firmware 
               
               
                 PR0133 
                 Memory requirement of firmware: 
                 ATSAM3X8E Datasheet 
               
               
                   
                 Minimum 128K ROM/256 Bytes RAM 
               
               
                 PR0134 
                 TLV2462 module is used as PCG sensor 
                 To pick up heart sounds and 
               
               
                   
                   
                 convert them to digital signal 
               
            
           
           
               
            
               
                 Usability Interface Requirements 
               
            
           
           
               
               
               
            
               
                 PR0201 
                 Power On/OFF switch - Momentary 
                 Allow user to power device on 
               
               
                   
                 press to switch ON/OFF of the device 
                 or off 
               
               
                 PR0202 
                 Transmit PCG (heart sounds) - provide 
                 Allow user to listen to PCG 
               
               
                   
                 “lub” (first) and “dub” (second) sounds 
                 signal 
               
               
                   
                 to audio output 
               
               
                 PR0203 
                 Transmit visual display of heart sound 
                 Display of PCG heart sounds 
               
               
                   
                 components to application software 
                 on application software 
               
               
                 PR0204 
                 Transmit ECG signal to application 
                 Allow user to view ECG signal 
               
               
                   
                 software 
               
               
                 PR0205 
                 Battery management - display battery 
                 Determine when battery needs 
               
               
                   
                 status on HealthyU device 
                 to be recharged 
               
               
                   
                   
                 Indicate when battery is 
               
               
                   
                   
                 charging 
               
               
                   
                   
                 Indicate when charging is 
               
               
                   
                   
                 completed 
               
               
                 PR0206 
                 View display under varied lighting 
                 IEC 60601-1-11; View 
               
               
                   
                 conditions 
                 information on display without 
               
               
                   
                   
                 glare under indoor/outdoor 
               
               
                   
                   
                 lighting conditions; including 
               
               
                   
                   
                 bright natural light, darkness, 
               
               
                   
                   
                 and artificial illumination 
               
               
                 PR0207 
                 Encrypted secure communications 
                 FDA guidance - Radio 
               
               
                   
                   
                 Frequency Wireless 
               
               
                   
                   
                 Technology in Medical device 
               
               
                   
                   
                 160s 
               
            
           
           
               
            
               
                 Packaging, Storage, and Labeling Requirements 
               
            
           
           
               
               
               
            
               
                 PR0301 
                 Instructions for Use (IFU) 
                 ISO 20417: 2021, IEC 60601-1 
               
               
                   
                   
                 7.9 Accompanying documents 
               
               
                   
                   
                 IFU should be available to 
               
               
                   
                   
                 provide guidance and/or be 
               
               
                   
                   
                 used as a reference by the end 
               
               
                   
                   
                 user. 
               
               
                 PR0302 
                 Labeling - use of symbols 
                 ISO 15223-1: 2016, IEC 60417, 
               
               
                   
                   
                 IEC 60601-1. Description of 
               
               
                   
                   
                 symbols use to be listed in IFU 
               
               
                 PR0303 
                 Expected service life labeling 
                 ISO 20417: 2021 
               
               
                   
                   
                 ISO 15223-1: 2016 
               
               
                   
                   
                 Clearly communicate product 
               
               
                   
                   
                 expected service life to end 
               
               
                   
                   
                 user 
               
               
                   
                   
                 Refer PR0502 
               
               
                 PR0304 
                 Storage temperature/Humidity range 
                 Provide information about 
               
               
                   
                   
                 storage conditions during 
               
               
                   
                   
                 transport and intended use 
               
               
                   
                   
                 environment 
               
               
                   
                   
                 IEC 60601-1-11, clause 4.2.2 
               
               
                   
                   
                 Temperature: −10□ to 40□; 
               
               
                   
                   
                 Relative Humidity: 10% to 
               
               
                   
                   
                 90% 
               
               
                 PR0305 
                 Battery charge time from depletion to 
                 IEC 60601-2-47, 201.7.9.2.101 
               
               
                   
                 90% charge in normal use is 3 hours 
                 Additional instruction for use, 
               
               
                   
                   
                 b)Internally powered ME 
               
               
                   
                   
                 equipment 
               
               
                 PR0306 
                 Packaging 
                 ASTM D4169-16 
               
               
                   
                   
                 IEC 60601-1-11 clause 4.2.2 
               
               
                   
                   
                 Level of packaging and 
               
               
                   
                   
                 packaging material required to 
               
               
                   
                   
                 protect and preserve 
               
               
                   
                   
                 functionality of the device 
               
               
                   
                   
                 during supply chain activities 
               
               
                 PR0307 
                 Legibility and Durability of Markings on 
                 IEC 60601-1, 7.1.2, 7.1.3. 
               
               
                   
                 the device, parts and its accessories 
                 Testing need to be done to 
               
               
                   
                   
                 prove markings may remain 
               
               
                   
                   
                 intact throughout lifetime of 
               
               
                   
                   
                 device 
               
               
                 PR0308 
                 On the device labeling to be done for 
                 IEC 60417 
               
               
                   
                 button of the device for user to 
               
               
                   
                 understand its functionality 
               
               
                 PR0309 
                 Mac id to be labeled on the device 
                 For user to verify device name 
               
               
                   
                   
                 and id during smart device 
               
               
                   
                   
                 Bluetooth pairing 
               
            
           
           
               
            
               
                 Regulatory and Standard Requirements 
               
            
           
           
               
               
               
            
               
                 PR0401 
                 All materials in contact with patient shall 
                 ISO 10993-1: 2018 
               
               
                   
                 be compatible with the human body for 
                 Minimize patient risk of 
               
               
                   
                 up to 24 hours per ISO 10993-1 
                 reaction caused by the product 
               
               
                 PR0402 
                 The materials used shall be phthalate 
                 Phthalates can damage the 
               
               
                   
                 free. 
                 liver, kidneys, lungs, and 
               
               
                   
                   
                 reproductive system 
               
               
                 PR0403 
                 Device shall be free of Bisphenol A 
                 EU MDR 2017/745 
               
               
                   
                 (BPA) 
               
               
                 PR0404 
                 Device shall be able to withstand 
                 IEC 60601-1-11: 2015 
               
               
                   
                 Mechanical shock, rough handling, etc. 
                 IEC 60601-2-47: 2012 
               
               
                   
                   
                 IEC 60601-1, 15.3 Mechanical 
               
               
                   
                   
                 Strength, Push test, Drop test, 
               
               
                   
                   
                 molding stress relief test, 
               
               
                   
                   
                 rough handling test. 
               
               
                 PR0405 
                 Environmental conditions - operating &amp; 
                 IEC 60601-1-11: 2015 
               
               
                   
                 storage temperature/humidity 
                 IEC 60601-2-47: 2012 
               
               
                 PR0406 
                 Patient leakage current 
                 IEC 60601-1, clause 8 
               
               
                   
                   
                 IEC 60601-1-11, clause 5 
               
               
                 PR0407 
                 Requirements for safety due to thermal 
                 IEC 60601-1, clause 11.1 - 
               
               
                   
                 contact with patient 
                 Protection against excessive 
               
               
                   
                   
                 temperatures and other 
               
               
                   
                   
                 hazards. 
               
               
                   
                   
                 Accessible/Applied parts of 
               
               
                   
                   
                 device made of metals, molded 
               
               
                   
                   
                 materials, plastic, glass, rubber 
               
               
                   
                   
                 should not exceed maximum 
               
               
                   
                   
                 temperature of 48 □ (time t &gt; 
               
               
                   
                   
                 1 min) &amp; 43 □ (time t &gt; 10 
               
               
                   
                   
                 min) during normal use 
               
               
                 PR0408 
                 Electromagnetic compatibility (EMC) 
                 Device shall meet EMC/EMI 
               
               
                   
                 and electromagnetic interference (EMI) 
                 requirements per IEC 60601-1- 
               
               
                   
                   
                 2: 2020 
               
               
                 PR0409 
                 Transport simulation requirements 
                 ASTM D4169-16 Standard 
               
               
                   
                 The packaging and device within shall 
                 Practice for Performance 
               
               
                   
                 meet all applicable device 
                 Testing of Shipping Containers 
               
               
                   
                 performance/functional requirements 
                 and Systems 
               
               
                   
                 following shipping per ASTM D4169-16 
               
               
                   
                 Standard Practice for Performance 
               
               
                   
                 Testing of Shipping Containers and 
               
               
                   
                 Systems 
               
               
                 PR0410 
                 Cleaning and Disinfection 
                 IEC 60601-1, 7.9.2.12, 
               
               
                   
                 Effects of multiple cleanings throughout 
                 Test device robustness to 
               
               
                   
                 expected service life of device to be 
                 cleaning for (365 days *2 
               
               
                   
                 evaluated. Cleaning procedure to be 
                 years*4 time a day) 2920 times 
               
               
                   
                 given in IFU 
               
               
                 PR0411 
                 Device shall be usable for lay users in 
                 IEC 60601-1-11, IEC 62366 
               
               
                   
                 home healthcare environment, to 
                 validation with lay persons as 
               
               
                   
                 enhance safe and effective use of device 
                 intended users 
               
               
                   
                   
                 FDA guidance on Usability 
               
               
                 PR0412 
                 Electrodes label and positioning need to 
                 For lay user to understand 
               
               
                   
                 be given in IFU 
                 device usage and properly 
               
               
                   
                   
                 capture ECG &amp; PCG 
               
            
           
           
               
            
               
                 Device Specification Requirements 
               
            
           
           
               
               
               
            
               
                 PR0501 
                 Expected service life 2 years 
                 Reliability, component life 
               
               
                   
                   
                 expectancy &amp; availability 
               
               
                   
                   
                 studies 
               
               
                 PR0502 
                 Distance between HealthyU device &amp; 
                 Refer BL652 Datasheet. 
               
               
                   
                 application software need to be within 10 
               
               
                   
                 meters for reliable data transmission 
               
            
           
           
               
            
               
                 Miscellaneous Requirements 
               
            
           
           
               
               
               
            
               
                 PR0601 
                 The device shall be RoHS and EU 
                 RoHS Directive 2011/65/EU 
               
               
                   
                 REACH compliant 
                 REACH Regulation (EC) No. 
               
               
                   
                   
                 1907/2006 
               
               
                 PR0602 
                 Device shall have curved edges 
                 No sharp edges; reduce risk of 
               
               
                   
                   
                 safety hazard 
               
               
                   
                   
                 IEC 60601-1, clause 9 - 
               
               
                   
                   
                 Protection against Mechanical 
               
               
                   
                   
                 Hazards of ME Equipment and 
               
               
                   
                   
                 ME Systems 
               
               
                   
               
            
           
         
       
     
     Additionally, firmware product requirements are detailed below in Table 5: 
     
       
         
           
               
             
               
                 TABLE 5 
               
             
            
               
                   
               
               
                 Software Requirements 
               
            
           
           
               
               
            
               
                 FRS ID 
                 Requirement 
               
               
                   
               
            
           
           
               
            
               
                 Healthy U Device Firmware 
               
            
           
           
               
               
            
               
                 FRS0001 
                 Software safety classification for device firmware is class B related to 
               
               
                   
                 moderate risk 
               
            
           
           
               
            
               
                 Functional Requirements 
               
            
           
           
               
               
            
               
                 FRS0101 
                 Real-time operating system (RTOS) used for watchdog timer to reset system. 
               
               
                   
                 This prevent system lockup if software is trapped in deadlock. 
               
               
                 FRS0102 
                 Compiler based on bare-metal C code, which allows to write the ARM 
               
               
                   
                 firmware. 
               
               
                 FRS0103 
                 Firmware is flashed into ATSAM3X8E ARM microcontroller. 
               
               
                 FRS0104 
                 Atmel IDE studio 7 - Integrated Environment Development used to develop 
               
               
                   
                 ARM Firmware. 
               
               
                 FRS0105 
                 Atmel ICE associated static analysis tool used to debug ARM firmware 
               
               
                 FRS0106 
                 Compatibility with Microsoft Visual Studio plug-ins and web browsers 
               
               
                   
                 Chrome, Edge, Firefox, Internet Explorer, Opera, Safari 
               
               
                 FRS0107 
                 Memory requirement for this firmware to work, Minimum 128K 
               
               
                   
                 ROM/256 Bytes RAM 
               
               
                 FRS0108 
                 Firmware is to initialize the Interface between Device display and 
               
               
                   
                 Microcontroller 
               
               
                 FRS0109 
                 When Power ON the HealthyU, LCD displays firmware version number, 
               
               
                   
                 name of the device, time &amp; battery status, labels of vitals that allow user to 
               
               
                   
                 know firmware version, time and what are all the vital parameters to be 
               
               
                   
                 displayed on HealthyU App 
               
               
                 FRS0110 
                 Bluetooth of HealthyU device is ON by default, connects with application 
               
               
                   
                 software as soon as it receives connection request signal from HealthyU 
               
               
                   
                 application software. 
               
               
                 FRS0111 
                 To provide real time data streaming with appropriate fidelity to HealthyU 
               
               
                   
                 mobile app; Firmware shall meet the baud rate of 115200 bps for Real time 
               
               
                   
                 data streaming 
               
               
                 FRS0112 
                 Continuous transfer of ECG Signal, Battery Level, Charging Status 
               
               
                 FRS0113 
                 Continuous transfer of PCG Signal 
               
               
                 FRS0114 
                 To mitigate risks of wireless technology, utilize Bluetooth module built in 
               
               
                   
                 security and encryption 
               
               
                 FRS0115 
                 HealthyU firmware shall advertise its MAC id to HealthyU app for pairing 
               
               
                   
                 with particular device. 
               
               
                 FRS0116 
                 2 KHz Sample rate for PCG Channel 1 &amp; 100 Hz sample rate for microphone 
               
               
                   
                 channel 2 
               
               
                   
                 No Filtering 
               
               
                 FRS0117 
                 100 Hz ECG Sample rate for each Channel 
               
               
                   
                 No Filtering 
               
               
                 FRS0118 
                 Initialize internal peripherals to allow microcontroller to communicate with 
               
               
                   
                 external modules. 
               
               
                 FRS0119 
                 Analog to Digital conversion (ADC): 
               
               
                   
                 The PCG signal from TLV2462 is connected to ADC Channel of the 
               
               
                   
                 Microcontroller. The ADC uses the ADC Clock to perform the Analog to 
               
               
                   
                 Digital conversions 
               
               
                 FRS0120 
                 Serial peripheral Interface (SPI): 
               
               
                   
                 The ECG signal from ADS 1293 is connected to microcontroller through 
               
               
                   
                 serial data link. 
               
               
                 FRS0121 
                 The Real-time Clock (RTC) peripheral is designed for time-of-day clock with 
               
               
                   
                 alarm and a two-hundred-year Gregorian calendar, complemented by a 
               
               
                   
                 programmable periodic interrupt. The alarm and calendar registers are 
               
               
                   
                 accessed by a 32-bit data bus. 
               
               
                 FRS0122 
                 Timer Interrupt used to update the global variable for key features such as 
               
               
                   
                 ECG and PCG 
               
               
                 FRS0123 
                 Data exchange between HealthyU app &amp; device 
               
               
                 FRS0124 
                 To ensure user privacy and information security, 
               
               
                   
                 Encryption protocol AES-128 available in the Bluetooth low energy device 
               
               
                   
                 encrypts data from device &amp; decrypts the same data by application that is 
               
               
                   
                 defined internally in the firmware &amp; software algorithms for secure &amp; 
               
               
                   
                 lossless data transfer using Bluetooth technology. 
               
               
                 FRS0125 
                 Internal software checks &amp; tests using watchdog timer are defined to ensure 
               
               
                   
                 device&#39;s intended functionality. 
               
            
           
           
               
            
               
                 Software System Inputs and Outputs 
               
            
           
           
               
               
            
               
                 FRS0201 
                 Data transfer between device and app 
               
               
                 FRS0202 
                 Lead 1 (potential between left -LA and right index finger- RA), Lead 2 
               
               
                   
                 (potential between left leg chest electrode -LL and right index finger -RA), 
               
               
                   
                 and Vector (potential between V and average of limb electrodes) are sent to 
               
               
                   
                 HealthyU application software 
               
               
                 FRS0203 
                 Incorporate error control processes (bit error rate, packet loss, and signal-to- 
               
               
                   
                 noise ratio) to ensure integrity of wireless transmitted data 
               
               
                 FRS0204 
                 Each data packet is generated with sequence number in incremental order to 
               
               
                   
                 facilitate integrity of data transmitted to mobile app 
               
               
                 FRS0205 
                 Device to transmit data packets at 115200 bps to meet threshold requirements 
               
               
                   
                 in mobile app 
               
               
                 FRS0206 
                 Scaling of input PCG signal with factor 0 to 2{circumflex over ( )}12 
               
               
                 FRS0207 
                 Scaling of input ECG signal with factor 0 to 2{circumflex over ( )}24 
               
            
           
           
               
            
               
                 Interfaces with other systems 
               
            
           
           
               
               
            
               
                 FRS0301 
                 BLE V 5.0 (and above) communication with mobile application software on 
               
               
                   
                 smart devices. 
               
               
                 FRS0302 
                 Universal Asynchronous Receive Transmit (UART) channel is incorporated 
               
               
                   
                 for connection between microcontroller and Bluetooth module to support 
               
               
                   
                 Bluetooth connectivity 
               
               
                 FRS0303 
                 Transmit real time data to mobile app at 115200 bps baud rate 
               
               
                 FRS0304 
                 Bluetooth data transmissions should contain header byte for synchronization 
               
            
           
           
               
            
               
                 Software-driven Information and Operator Messages 
               
            
           
           
               
               
            
               
                 FRS0401 
                 Battery Charging Indication 
               
               
                   
                 The Amber LED is ON while charging. 
               
               
                 FRS0402 
                 Status indicators for Battery Management 
               
               
                   
                 Firmware shall provide battery power level using the battery icon: 
               
               
                   
                 battery power level: 5 out of 5 bars are lighted. 
               
               
                   
                 battery power level: 4 out of 5 bars are lighted. 
               
               
                   
                 battery power level: 3 out of 5 bars are lighted. 
               
               
                   
                 battery power level: 2 out of 5 bars are lighted. 
               
               
                   
                 battery power level: 1 out of 5 bars are lighted. 
               
               
                   
                 Low battery level: The LCD Display pop-up indication message (Battery 
               
               
                   
                 Low, please charge the device) and the Buzzer is ON from that instant, 
               
               
                   
                 device may perform for maybe 30 minutes. This may allow user to know 
               
               
                   
                 when to charge. 
               
               
                 FRS0403 
                 Firmware shall control status indicators for device function based on the 
               
               
                   
                 Realtime Data Signal 
               
            
           
           
               
            
               
                 Security Requirements 
               
            
           
           
               
               
            
               
                 FRS0501 
                 Firmware shall enable Smart/Auto pairing with mobile app for single point to 
               
               
                   
                 point communication. 
               
               
                 FRS0503 
                 Secure device from access by unauthorized remote devices; unintended 
               
               
                   
                 remote device cannot read the signal from device because of the signal 
               
               
                   
                 encryption and packet structure 
               
               
                 FRS0502 
                 AES 128 encryption of data transmitted by device through use of BLE 5.0 or 
               
               
                   
                 above 
               
            
           
           
               
            
               
                 User Interface Requirements 
               
            
           
           
               
               
            
               
                 FRS0601 
                 Device enters standby mode when charging battery 
               
               
                 FRS0602 
                 Transmit PCG (heart sounds) - provide “lub” (first) and “dub” (second) 
               
               
                   
                 sounds to audio output 
               
               
                 FRS0603 
                 Transmit visual display of heart sound components to application software 
               
               
                 FRS0604 
                 Transmit ECG signal to application software to allow user to view ECG 
               
               
                   
                 waveform 
               
               
                 FRS0605 
                 Color LCD Display visible under various lighting conditions (100-1500 lx) 
               
               
                 FRS0606 
                 Firmware should detect when user presses Power ON/OFF key 
               
               
                 FRS0607 
               
            
           
           
               
            
               
                 Data Definition and Database Requirements 
               
            
           
           
               
               
            
               
                 FRS0701 
                 Format of packets sending ECG/PCG information. 
               
            
           
           
               
            
               
                 Installation and Acceptance Requirements at 
               
               
                 Operation and Maintenance Site(s) 
               
            
           
           
               
               
            
               
                 FRS0801 
                 BLE Script loading is done via JTAG to support device and mobile app 
               
               
                   
                 pairing. 
               
            
           
           
               
            
               
                 Operation and Maintenance Requirements 
               
            
           
           
               
               
            
               
                 FRS0901 
                 JTAG Cable is used to load the program in HealthyU board. Firmware 
               
               
                   
                 loading &amp; upgrading is handled by manufacturer. 
               
               
                 FRS0902 
                 JTAG programming, security controlled no read write access. 
               
            
           
           
               
            
               
                 User Documentation Requirements 
               
            
           
           
               
               
            
               
                 FRS1001 
                 User manual to understand the functionality, handling &amp; maintenance of 
               
               
                   
                 device-app interface &amp; user interface 
               
            
           
           
               
            
               
                 Regulatory Requirements 
               
            
           
           
               
               
            
               
                 FRS1201 
                 Compliance with IEC 62304 
               
               
                 FRS1202 
                 Guidance for the Content of Premarket Submissions for Software Contained 
               
               
                   
                 in Medical device 160s- Guidance for Industry and FDA Staff; 2005 
               
               
                 FRS1203 
                 Guidance for Industry and FDA Staff- Radiofrequency wireless technology in 
               
               
                   
                 medica devices; 2013 
               
               
                 FRS1204 
                 Guidance for Industry and FDA Staff- off the shelf software use in medical 
               
               
                   
                 device 160s; 2019 
               
               
                 FRS1205 
                 Warnings and cautions are provided to user using device labels, package label 
               
               
                   
                 and IFU 
               
            
           
           
               
            
               
                 Critical requirements/Essential performance 
               
            
           
           
               
            
               
                 Auto-pairing of device &amp; app 
               
               
                 Measurement of ECG &amp; PCG 
               
               
                 Maintenance of data integrity &amp; security 
               
               
                   
               
            
           
         
       
     
     In some substantiations of the medical device  160 , multiple timers are employed. When Timer 2 is called the ECG Data is updated to global buffer, as seen at  FIG. 20  at  2000 . When Timer 3 is called the PCG channel 2 Data is updated to global buffer, as seen at  FIG. 21  at  2100 . When Timer 4 is called the PCG channel 1 Data is updated to global buffer, as seen at  FIG. 22  at  2200 . The microcontroller program may check the time when the app is paired with the device. If the time changes, it may update the time on device display, as seen at  FIG. 23  at  2300 . The microcontroller program may check the battery status, when the battery is low it may switch on buzzer module. FreeRTOS is a real time scheduler (in round-robin manner) for microcontroller program to check the battery status and update the battery icon in display. Battery functioning is seen at  FIG. 25  at  2500 .  FIG. 26 , at  2600 , defines how the time, firmware revision and battery level data are transferred between app and device.  FIG. 27 , at  2700 , defines how the BLE is transfer ECG and PCG data. 
     In the medical device  160 , in this particular implementation, the microcontroller is used to monitor, process, and interact with the internal as well as external peripherals. When the system is powered on, it may initialize the ports, pins and interfaces of the microcontroller, as seen at  FIG. 28  at  2800 . 
     The Watchdog Timer can be used to prevent system lock-up if the software becomes trapped in a deadlock. It features a 12-bit down counter that allows a watchdog period of up to 16 seconds (slow clock at 32 kHz). It can generate a general reset or a processor reset only. In addition, it can be stopped while the processor is in debug mode or idle mode. The reset time of watchdog timer is 1 sec. It may continuously monitor the microcontroller program, to update the ECG or PCG data as per data protocol format and sends to Bluetooth low energy when it is formatted.  FIG. 29  illustrates the activity of the watchdog timer, at  2900 . 
     An analog front end (AFE) connects with the microcontroller over SPI channel. Sampling rate of the analog front end is 100 Hz. The ECG signal from AFE is connected via a synchronous serial data link (Serial Peripheral Interface) that provides communication with Analog front end in Master or Slave Mode with Microcontroller for Biopotential. Master Out Slave In (MOSI): This data line supplies the output data from the master microcontroller shifted into the input(s) of the slave analog front end. Master In Slave Out (MISO): This data line supplies the output data from a slave analog front end to the input of the master microcontroller. There may be no more than one slave transmitting data during any particular transfer. Serial Clock (SPCK): This control line is driven by the master and regulates the flow of the data bits. The master may transmit data at a variety of baud rates; the SPCK line cycles once for each bit that is transmitted. Slave Select (NSS): This control line allows slave to be turned on and off by hardware. 
     The PCG signal from the AFE is connected to ADC Channel of the Microcontroller. The ADC is based on a 12-bit Analog-to-Digital Converter (ADC) managed by an ADC Controller. It also integrates a 16-to-1 analog multiplexer, making possible the analog-to-digital conversions of 16 analog lines. The conversions extend from 0V to ADVREF. The ADC supports an 10-bit or 12-bit resolution mode, and conversion results are reported in a common register for all channels, as well as in a channel-dedicated register. Software trigger, external trigger on rising edge of the ADTRG pin or internal triggers from Timer Counter output(s) are configurable. 
     The comparison circuitry allows automatic detection of values below a threshold, higher than a threshold, in a given range or outside the range, thresholds and ranges being fully configurable. The ADC Controller internal fault output is directly connected to PWM Fault input. This input can be asserted by means of comparison circuitry in order to immediately put the PWM outputs in a safe state (pure combinational path). The ADC also integrates a Sleep Mode and a conversion sequencer and connects with a PDC channel. These features reduce both power consumption and processor intervention. This ADC has a selectable single-ended or fully differential input and benefits from a 2-bit programmable gain. A whole set of reference voltages is generated internally from a single external reference voltage node that may be equal to the analog supply voltage. An external decoupling capacitance is required for noise filtering. A digital error correction circuit based on the multi-bit redundant signed digit (RSD) algorithm is employed in order to reduce INL and DNL errors. 
     The ADC uses the ADC Clock to perform the conversions. Converting a single analog value to a 12-bit digital data requires Tracking Clock cycles as defined in the field TRACKTIM of the “ADC MODE REG” and Transfer Clock cycles as defined in the field TRANSFER of the same register. The ADC Clock frequency is selected in the PRESCAL field of the Mode Register (ADC_MR). The tracking phase starts during the conversion of the previous channel. If the tracking time is longer than the conversion time, the tracking phase is extended to the end of the previous conversion. The ADC clock range is between MCK/2, if PRESCAL is 0, and MCK/512, if PRESCAL is set to 255 (0xFF). PRESCAL should be programmed in order to provide an ADC clock frequency. For HealthyU the MCLK is equals to 84 MHz, The ADC clock range is MCK/512 and PRESCAL is set to 255 (0xFF). So the ADC clock frequency is 1.64 KHz. 
     The conversion is performed on a full range between 0V and the reference voltage pin ADVREF. Analog inputs between these voltages convert to values based on a linear conversion. The ADC supports 10-bit or 12-bit resolutions. The 10-bit selection is performed by setting the LOWRES bit in the ADC Mode Register (ADC_MR). By default, after a reset, the resolution is the highest and the DATA field in the data registers is fully used. By setting the LOWRES bit, the ADC switches to the lowest resolution and the conversion results can be read in the lowest significant bits of the data registers. The two highest bits of the DATA field in the corresponding ADC_CDR register and of the LDATA field in the ADC_LCDR register read 0. Moreover, when a PDC channel is connected to the ADC, 12-bit or 10-bit resolution sets the transfer request size to 16 bits. For HealthyU 12 bit resolution is set by setting LOWRES (4) bit to zero in ADC Mode Register. 
     When a conversion is completed, the resulting 12-bit digital value is stored in the Channel Data Register (ADC_CDRx) of the current channel and in the ADC Last Converted Data Register (ADC_LCDR). By setting the TAG option in the ADC_EMR, the ADC_LCDR presents the channel number associated to the last converted data in the CHNB field. The channel EOC bit in the Status Register (ADC_SR) is set and the DRDY is set. In the case of a connected PDC channel, DRDY rising triggers a data transfer request. In any case, either EOC and DRDY can trigger an interrupt. Reading one of the ADC_CDR registers clears the corresponding EOC bit. Reading ADC_LCDR clears the DRDY bit and EOC bit corresponding to the last converted channel. 
     The communication between HealthyU App &amp; HealthyU device is achieved by Bluetooth module. It is a v5.0 single mode Bluetooth module. By default BLE5.0 is aes-128 encrypted. When the device is powered ON and the BLE initialized and transmit its broadcast address, if it receives pairing query from HealthyU App it may acknowledge the pairing query and based on this the connection is established.  FIG. 30 , at  3000 , illustrates this pairing process. BLE module is connect with the microcontroller over UART channel. It provides access to the BLE module 2-wire UART interface (TX, RX). 
     HealthyU application may sync all HealthyU device as soon as connected over Bluetooth follow by auscultation page. Table 6 provides the command tor time updates: 
     
       
         
           
               
             
               
                 TABLE 6 
               
               
                   
               
               
                 Command for Time Update 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                   
                 BYTE0 
                 START_BYTE1 
                 FE 
               
               
                   
                 BYTE1 
                 START_BYTE2 
                 EF 
               
               
                   
                 BYTE2 
                 FrameCount 
                 1 
               
               
                   
                 BYTE3 
                 RxCommand_Byte 
                 FA 
               
               
                   
                 BYTE4 
                 RxLenOfByte 
                 7 
               
               
                   
                 BYTE5 
                 Rx_Hours 
               
               
                   
                 BYTE6 
                 Rx_Min 
               
               
                   
                 BYTE7 
                 Rx_Sec 
               
               
                   
                 BYTE8 
                 Rx_Day 
               
               
                   
                 BYTE9 
                 Rx_Month 
               
               
                   
                 BYTE10 
                 Rx_YearMSB 
               
               
                   
                 BYTE11 
                 Rx_YearLSB 
               
               
                   
                 BYTE12 
                 Rx_CRC 
                 xx 
               
               
                   
                 BYTE13 
                 END Byte 
                 0 
               
               
                   
                 BYTE14 
                 END Byte 
                 A5 
               
               
                   
                   
               
            
           
         
       
     
     Where: 
     Start of Frame: It is start byte to define start of packet. 
       FE=START_BYTE1 
       EF=START_BYTE2 
     Data Type: 1=Defines the type of the Data. 
     Frame Count: 1=It define frame count of the packet. 
     Command Byte: FA=Defines Receiver command byte of Timer update. 
     Hours: Defines Hours byte 
     Min: Defines minutes byte 
     Sec: Defines seconds byte 
     Date: Defines date byte 
     Month: Defines month byte 
     Year MSB: Defines most significant byte of the year 
     Year LSB: Defines least significant byte of the year 
     LenOfByte: 7=Defines the Length of the Byte excluding StartByte and EndByte 
     Rx_CRC: xx=Defines Receiver Cyclic Redundancy check for error detecting. 
     END Byte: Defines end of packet 
       0=End byte 1 
       A5=End byte 2 
     Table 7 provides ECG records request for the medical device  160  to the application running on the user device: 
     
       
         
           
               
             
               
                 TABLE 7 
               
               
                   
               
               
                 ECG Record Request 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                   
                 Byte0 
                 START1 
                 0xFE 
               
               
                   
                 Byte1 
                 START2 
                 0xFB 
               
               
                   
                 Byte2 
                 ECG Data type 
                 0x01 
               
               
                   
                 Byte3 
                 CRC of byte 4 to 15 
               
               
                   
                 Byte4 
                 ECG_CH1_Value1 MSB 
                 xx 
               
               
                   
                 Byte5 
                 ECG_CH1_Value1 LSB 
                 xx 
               
               
                   
                 Byte6 
                 ECG_CH1_Value2 MSB 
                 xx 
               
               
                   
                 Byte7 
                 ECG_CH1_Value2 LSB 
                 xx 
               
               
                   
                 Byte8 
                 ECG_CH2_Value1 MSB 
                 xx 
               
               
                   
                 Byte9 
                 ECG_CH2_Value1 LSB 
                 xx 
               
               
                   
                 Byte10 
                 ECG_CH2_Value2 MSB 
                 xx 
               
               
                   
                 Byte11 
                 ECG_CH2_Value2 LSB 
                 xx 
               
               
                   
                 Byte12 
                 ECG_CH3_Value1 MSB 
                 xx 
               
               
                   
                 Byte13 
                 ECG_CH3_Value1 LSB 
                 xx 
               
               
                   
                 Byte14 
                 ECG_CH3_Value2 MSB 
                 xx 
               
               
                   
                 Byte15 
                 ECG_CH3_Value2 LSB 
                 xx 
               
            
           
           
               
               
               
               
            
               
                   
                 Byte16 
                 0 
                   
               
               
                   
                 Byte17 
                 0 
               
               
                   
                 Byte18 
                 0 
               
            
           
           
               
               
               
               
            
               
                   
                 Byte19 
                 END Byte 
                 0 
               
               
                   
                   
               
            
           
         
       
     
     Where: 
     Start of Frame: It is start byte to define start of packet. 
       0xFE=Byte 0 
       0xFB=Byte 1 
     CMD Byte: Defines the Command Byte. 
       0x01=Byte 2 
     CRC: Defines CRC for Byte 4 to Byte 15 
     ECG Data (MSB): xx=Defines Most Significant Byte of the ECG data. 
     ECG Data (LSB): xx=Defines Least Significant Byte of the ECG Data. 
     Table 8 provides the PCG record request for the medical device  160  to the application in the user device: 
     
       
         
           
               
             
               
                 TABLE 8 
               
               
                   
               
               
                 PCG Record Request 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                   
                 Byte1 
                 START1 
                 0xFE 
               
               
                   
                 Byte1 
                 START2 
                 0xFB 
               
               
                   
                 Byte2 
                 CMD Byte 
                 0x02 
               
               
                   
                 Byte3 
                 CRC for Byte 4 to 18 
               
               
                   
                 Byte4 
                 PCG Data 1 
                 xx 
               
               
                   
                 Byte5 
                 PCG Data 2 
                 xx 
               
               
                   
                 Byte6 
                 PCG Data 3 
                 xx 
               
               
                   
                 Byte7 
                 PCG Data 4 
                 xx 
               
               
                   
                 Byte8 
                 PCG Data 5 
                 xx 
               
               
                   
                 Byte9 
                 PCG Data 6 
                 xx 
               
               
                   
                 Byte10 
                 PCG Data 7 
                 xx 
               
               
                   
                 Byte11 
                 PCG Data 8 
                 xx 
               
               
                   
                 Byte12 
                 PCG Data 9 
                 xx 
               
               
                   
                 Byte13 
                 PCG Data 10 
                 xx 
               
               
                   
                 Byte14 
                 PCG Data 11 
                 xx 
               
               
                   
                 Byte15 
                 PCG Data 12 
                 xx 
               
               
                   
                 Byte16 
                 PCG Data 13 
                 xx 
               
               
                   
                 Byte17 
                 PCG Data 14 
                 xx 
               
               
                   
                 Byte18 
                 PCG Data 15 
                 xx 
               
               
                   
                 Byte19 
                 END Byte 
                 0 
               
               
                   
                   
               
            
           
         
       
     
     Where: 
     Start of Frame: It is start byte to define start of packet. 
       0xFE=Byte 1 
       0xEF=Byte 2 
     CMD Byte: Defines the Command Byte. 
       0x02=Byte 2 
     CRC: Defines CRC for Byte 4 to Byte 18 
     PCG Data: xx=Defines the PCG data. 
     Table 9 provides a second sensor record request for the medical device  160  from the application on the user device: 
     
       
         
           
               
             
               
                 TABLE 9 
               
               
                   
               
               
                 Second Sensor Record Request 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                   
                 Byte1 
                 START1 
                 0xFE 
               
               
                   
                 Byte1 
                 START2 
                 0xFB 
               
               
                   
                 Byte2 
                 CMD Byte 
                 0x03 
               
               
                   
                 Byte3 
                 CRC for Byte 4 to 18 
               
               
                   
                 Byte4 
                 Second sensor Data 1 
                 xx 
               
               
                   
                 Byte5 
                 Second sensor Data 2 
                 xx 
               
               
                   
                 Byte6 
                 Second sensor Data 3 
                 xx 
               
               
                   
                 Byte7 
                 Second sensor Data 4 
                 xx 
               
               
                   
                 Byte8 
                 Second sensor Data 5 
                 xx 
               
               
                   
                 Byte9 
                 Second sensor Data 6 
                 xx 
               
               
                   
                 Byte10 
                 Second sensor Data 7 
                 xx 
               
               
                   
                 Byte11 
                 Second sensor Data 8 
                 xx 
               
               
                   
                 Byte12 
                 Second sensor Data 9 
                 xx 
               
               
                   
                 Byte13 
                 Second sensor Data 10 
                 xx 
               
               
                   
                 Byte14 
                 Second sensor Data 11 
                 xx 
               
               
                   
                 Byte15 
                 Second sensor Data 12 
                 xx 
               
               
                   
                 Byte16 
                 Second sensor Data 13 
                 xx 
               
               
                   
                 Byte17 
                 Second sensor Data 14 
                 xx 
               
               
                   
                 Byte18 
                 Second sensor Data 15 
                 xx 
               
               
                   
                 Byte19 
                 END Byte 
                 0 
               
               
                   
                   
               
            
           
         
       
     
     Where: 
     Start of Frame: It is start byte to define start of packet. 
       0xFE=Byte 1 
       0xEF=Byte 2 
     CMD Byte: Defines the Command Byte. 
       0x02=Byte 2 
     CRC: Defines CRC for Byte 4 to Byte 18 
     PCG Data: xx=Defines the PCG data 
     Table 10 provides a device battery level request: 
     
       
         
           
               
             
               
                 TABLE 10 
               
               
                   
               
               
                 Device Battery Level Request 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                   
                 Byte1 
                 START1 
                 0xFE 
               
               
                   
                 Byte2 
                 START2 
                 0xEF 
               
               
                   
                 Byte3 
                 Cmd Byte 
                 0x64 
               
               
                   
                 Byte4 
                 Len of Data 
                 3 
               
               
                   
                 Byte5 
                 BATLevel_MSB 
               
               
                   
                 Byte6 
                 BATLevel_LSB 
               
               
                   
                 Byte7 
                 Charge Status 
                 1 
               
               
                   
                 Byte8 
                 CRC of Data 
               
               
                   
                 Byte9 
                 END1 
                 0 
               
               
                   
                 Byte10 
                 END2 
                 0xA5 
               
               
                   
                   
               
            
           
         
       
     
     Where: 
     Start of Frame: It is start byte to define start of packet. 
       0xFE=Byte 1 
       0xEF=Byte 2 
     Command Byte: 0x64=Defines the Command Byte. 
     Length of data: 3=It define complete length of Data. 
     BATLevel MSB: Defines Most Significant Byte of the battery level data. 
     BATLevel LSB: Defines Least Significant Byte of the battery level data. 
     Charge Status: 1=Defines charge status of the device 
     CRC of Data: Defines the Cyclic Redundancy Check of data for error detecting 
     End of Frame: Defines End of frame 
       0=End Byte 1 
       0xA5=End Byte 2 
     Table 11 provides the application to medical device  160  version command: 
     
       
         
           
               
             
               
                 TABLE 11 
               
               
                   
               
               
                 Device Version Command 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                   
                 BYTE0 
                 START_BYTE1 
                 FE 
               
               
                   
                 BYTE1 
                 START_BYTE2 
                 EF 
               
               
                   
                 BYTE2 
                 FrameCount 
                 1 
               
               
                   
                 BYTE3 
                 RxCommand_Byte 
                 0xFB 
               
               
                   
                 BYTE4 
                 RxLenOfByte 
                 0 
               
               
                   
                 BYTE5 
                 Feature Use 
                 0 
               
               
                   
                 BYTE6 
                 Feature Use 
                 0 
               
               
                   
                 BYTE7 
                 CRC of Data 
               
               
                   
                 BYTE8 
                 END1 
                 0 
               
               
                   
                 BYTE9 
                 END2 
                 0xA5 
               
               
                   
                   
               
            
           
         
       
     
     Where: 
     Start of Frame: It is start byte to define start of packet.
         FE=Byte 1   EF=Byte 2       

     Frame Count: 1=Defines Frame Count 
     Command Byte: 0xFB=Defines the Command Byte. 
     Length of data: 0=It define complete length of Data. 
     Feature Use: 0=Defines Feature Use of Device version. 
     Feature Use: 0=Defines Feature Use of Device version. 
     CRC of Data: Defines the Cyclic Redundancy Check of data for error detecting 
     End of Frame: Defines End of frame 
       0=End Byte 1 
       0xA5=End Byte 2 
     Table 12 provides the medical device  160  to the application version command: 
     
       
         
           
               
             
               
                 TABLE 12 
               
               
                   
               
               
                 Application Version Command 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
               
            
               
                   
                 Byte1 
                 START1 
                 0xFE 
               
               
                   
                 Byte2 
                 START2 
                 0xEF 
               
               
                   
                 Byte3 
                 Cmd Byte 
                 0x65 
               
               
                   
                 Byte4 
                 CRC of data 
                 4 
               
               
                   
                 Byte5 
                 Firmware Version Byte1 
               
               
                   
                 Byte6 
                 Firmware Version Byte2 
               
               
                   
                 Byte7 
                 Firmware Version Byte3 
                 1 
               
               
                   
                 Byte8 
                 Firmware Version Byte4 
               
               
                   
                 Byte9 
                 END1 
                 0 
               
               
                   
                 Byte10 
                 END2 
                 0xA5 
               
               
                   
                   
               
            
           
         
       
     
     Where: 
     Start of Frame: It is start byte to define start of packet. 
       0xFE=Byte 1 
       0xEF=Byte 2 
     Command Byte: 0x65=HealthyU device to HealthyU App command Byte 
     CRC: 4=It define the CRC of data. 
     Firmware Version Byte1: Defines Firmware Version 
     Firmware Version Byte2: Defines Firmware Version 
     Firmware Version Byte3: 1=Defines Firmware Version 
     Firmware Version Byte4: Defines Firmware Version 
     End of Frame: Defines End of frame 
       0=End Byte 1 
       0×A5=End Byte 2
 
     An LCD is used for displaying Time, PCG icon with Text, ECG icon with Text and Battery status icon in default. The supply voltage for the LCD is LCD_3V3D.  FIGS. 31 and 32  provide two different screen renderings. In  FIG. 31 , the time, battery indicator, and sensory icons are illustrated, at  3100 . In an alternate display, seen at  FIG. 32 , the pulse rate, heart rate, battery, time, blood pressure, and ECG/PCG signals may also be displayed, at  3200 . Table 13 provides a set of example LCD system commands: 
     
       
         
           
               
             
               
                 TABLE 13 
               
             
            
               
                   
               
               
                 LCD System Commands 
               
            
           
           
               
               
               
               
               
               
               
               
               
               
               
               
               
               
               
            
               
                 Instruction 
                 D/CX 
                 WRX 
                 RDX 
                 D17-8 
                 D7 
                 D6 
                 D5 
                 D4 
                 D3 
                 D2 
                 D1 
                 D0 
                 Hex 
                 Function 
               
               
                   
               
               
                 NOP 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 0 
                 0 
                 0 
                 0 
                 0 
                 (00h) 
                 No 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 operation 
               
               
                 SWRESET 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 0 
                 0 
                 0 
                 0 
                 1 
                 (01h) 
                 Software 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 reset 
               
               
                 RDDID 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 0 
                 0 
                 1 
                 0 
                 0 
                 (04h) 
                 Read display 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 ID 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 ID17 
                 ID16 
                 ID15 
                 ID14 
                 ID13 
                 ID12 
                 ID11 
                 ID10 
                   
                 ID1 read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 ID27 
                 ID26 
                 ID25 
                 ID24 
                 ID23 
                 ID22 
                 ID21 
                 ID20 
                   
                 ID2 read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 ID37 
                 ID36 
                 ID35 
                 ID34 
                 ID33 
                 ID32 
                 ID31 
                 ID30 
                   
                 ID3 read 
               
               
                 RDDST 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 0 
                 1 
                 0 
                 0 
                 1 
                 (09h) 
                 Read display 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 status 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 BSTON 
                 MY 
                 MX 
                 MV 
                 ML 
                 RGB 
                 MH 
                 ST24 
                   
                 — 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 ST23 
                 IFPF2 
                 IFPF1 
                 IFPF0 
                 IDMON 
                 PTLON 
                 SLOUT 
                 NORON 
                   
                 — 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 ST15 
                 ST14 
                 INVON 
                 ST12 
                 ST11 
                 DISON 
                 TEON 
                 GCS2 
                   
                 — 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 GCS1 
                 GCS0 
                 TEM 
                 ST4 
                 ST3 
                 ST2 
                 ST1 
                 ST0 
                   
                 — 
               
               
                 RDDPM 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 0 
                 1 
                 0 
                 1 
                 0 
                 (0Ah) 
                 Read display 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 power 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 BSTON 
                 IDMON 
                 PTLON 
                 SLPOUT 
                 NORON 
                 DISON 
                 0 
                 0 
                   
                 — 
               
               
                 RDDMADCTL 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 0 
                 1 
                 0 
                 1 
                 1 
                 (0Bh) 
                 Read display 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 MY 
                 MX 
                 MV 
                 ML 
                 RGB 
                 MH 
                 0 
                 0 
                   
                 — 
               
               
                 RDDCOLMOD 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 0 
                 1 
                 1 
                 0 
                 0 
                 (0Ch) 
                 Read display 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 pixel 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 0 
                 D6 
                 D5 
                 D4 
                 0 
                 D2 
                 D1 
                 D0 
                   
                 — 
               
               
                 RDDIM 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 0 
                 1 
                 1 
                 0 
                 1 
                 (0Dh) 
                 Read display 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 image 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 VSSON 
                 0 
                 INVON 
                 0 
                 0 
                 GC2 
                 GC1 
                 GC0 
                   
                 — 
               
               
                 RDDSM 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 0 
                 1 
                 1 
                 1 
                 0 
                 (0Eh) 
                 Read display 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 signal 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 TEON 
                 TEM 
                 0 
                 0 
                 0 
                 0 
                 0 
                 0 
                   
                 — 
               
               
                 RDDSDR 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 0 
                 1 
                 1 
                 1 
                 1 
                 (0Fh) 
                 Read display 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 self- 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 diagnostic 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 result 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 D7 
                 D6 
                 0 
                 0 
                 0 
                 0 
                 0 
                 0 
                   
                 — 
               
               
                 SLPIN 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 1 
                 0 
                 0 
                 0 
                 0 
                 (10h) 
                 Sleep in 
               
               
                 SLPOUT 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 1 
                 0 
                 0 
                 0 
                 1 
                 (11h) 
                 Sleep out 
               
               
                 PTLON 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 1 
                 0 
                 0 
                 1 
                 0 
                 (12h) 
                 Partial 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 mode on 
               
               
                 NORON 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 1 
                 0 
                 0 
                 1 
                 1 
                 (13h) 
                 Partial off 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 (Normal) 
               
               
                 INVOFF 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 0 
                 0 
                 0 
                 0 
                 0 
                 (20h) 
                 Display 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 inversion off 
               
               
                 INVON 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 0 
                 0 
                 0 
                 0 
                 1 
                 (21h) 
                 Display 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 inversion on 
               
               
                 GAMSET 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 0 
                 0 
                 0 
                 0 
                 1 
                 (26h) 
                 Display 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 0 
                 0 
                 GC3 
                 GC2 
                 GC1 
                 GC0 
                   
                 inversion on 
               
               
                 DISPOFF 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 0 
                 1 
                 0 
                 0 
                 0 
                 (28h) 
                 Display off 
               
               
                 DISPON 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 0 
                 1 
                 0 
                 0 
                 1 
                 (29h) 
                 Display on 
               
               
                 CASET 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 0 
                 1 
                 0 
                 1 
                 0 
                 (2Ah) 
                 Column 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 address set 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 XS15 
                 XS14 
                 XS13 
                 XS12 
                 XS11 
                 XS10 
                 XS9 
                 XS8 
                   
                 X address 
               
               
                   
                 1 
                 ↑ 
                 1 
                   
                 XS7 
                 XS6 
                 XS5 
                 XS4 
                 XS3 
                 XS2 
                 XS1 
                 XS0 
                   
                 start: 0 ≤ 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 XS ≤ X 
               
               
                   
                 1 
                 ↑ 
                 1 
                   
                 XE15 
                 XE14 
                 XE13 
                 XE12 
                 XE11 
                 XE10 
                 XE9 
                 XE8 
                   
                 X address 
               
               
                   
                 1 
                 ↑ 
                 1 
                   
                 XE7 
                 XE6 
                 XE5 
                 XE4 
                 XE3 
                 XE2 
                 XE1 
                 XE0 
                   
                 start: S ≤ 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 XE ≤ X 
               
               
                 RASET 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 0 
                 1 
                 0 
                 1 
                 1 
                 (2Bh) 
                 Row 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 address set 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 YS15 
                 YS14 
                 YS13 
                 YS12 
                 YS11 
                 YS10 
                 YS9 
                 YS8 
                   
                 Y address 
               
               
                   
                 1 
                 ↑ 
                 1 
                   
                 YS7 
                 YS6 
                 YS5 
                 YS4 
                 YS3 
                 YS2 
                 YS1 
                 YS0 
                   
                 start: 0 ≤ 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 YS ≤ Y 
               
               
                   
                 1 
                 ↑ 
                 1 
                   
                 YE15 
                 YE14 
                 YE13 
                 YE12 
                 YE11 
                 YE10 
                 YE9 
                 YE8 
                   
                 Y address 
               
               
                   
                 1 
                 ↑ 
                 1 
                   
                 YE7 
                 YE6 
                 YE5 
                 YE4 
                 YE3 
                 YE2 
                 YE1 
                 YE0 
                   
                 start: S ≤ 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 YE ≤ Y 
               
               
                 RAMWR 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 0 
                 1 
                 1 
                 0 
                 0 
                 (2Ch) 
                 Memory write 
               
               
                   
                 1 
                 ↑ 
                 1 
                 D1[17:8] 
                 D1[7] 
                 D1[6] 
                 D1[5] 
                 D1[4] 
                 D1[3] 
                 D1[2] 
                 D1[1] 
                 D1[0] 
                   
                 Write data 
               
               
                   
                 1 
                 ↑ 
                 1 
                 Dx[17:8] 
                 Dx[7] 
                 Dx[6] 
                 Dx[5] 
                 Dx[4] 
                 Dx[3] 
                 Dx[2] 
                 Dx[1] 
                 Dx[0] 
               
               
                   
                 1 
                 ↑ 
                 1 
                 Dn[17:8] 
                 Dn[7] 
                 Dn[6] 
                 Dn[5] 
                 Dn[4] 
                 Dn[3] 
                 Dn[2] 
                 Dn[1] 
                 Dn[0] 
               
               
                 RAMRD 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 0 
                 1 
                 1 
                 1 
                 0 
                 (2Eh) 
                 Memory read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 D1[17:8] 
                 D1[7] 
                 D1[6] 
                 D1[5] 
                 D1[4] 
                 D1[3] 
                 D1[2] 
                 D1[1] 
                 D1[0] 
                   
                 Read data 
               
               
                   
                 1 
                 1 
                 ↑ 
                 Dx[17:8] 
                 Dx[7] 
                 Dx[6] 
                 Dx[5] 
                 Dx[4] 
                 Dx[3] 
                 Dx[2] 
                 Dx[1] 
                 Dx[0] 
               
               
                   
                 1 
                 1 
                 ↑ 
                 Dn[17:8] 
                 Dn[7] 
                 Dn[6] 
                 Dn[5] 
                 Dn[4] 
                 Dn[3] 
                 Dn[2] 
                 Dn[1] 
                 Dn[0] 
               
               
                 PTLAR 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 1 
                 0 
                 0 
                 0 
                 0 
                 (30h) 
                 Partial 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 start/end 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 address set 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 PSL15 
                 PSL14 
                 PSL13 
                 PSL12 
                 PSL11 
                 PSL10 
                 PSL9 
                 PSL8 
                   
                 Partial start 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 address: 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 (0, 1, 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 2, . . . P) 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 PSL7 
                 PSL6 
                 PSL5 
                 PSL4 
                 PSL3 
                 PSL2 
                 PSL1 
                 PSL0 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 PEL15 
                 PEL14 
                 PEL13 
                 PEL12 
                 PEL11 
                 PEL10 
                 PEL9 
                 PEL8 
                   
                 Partial end 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 address(0, 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 1, 2, 3,, P) 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 PEL7 
                 PEL6 
                 PEL5 
                 PEL4 
                 PEL3 
                 PEL2 
                 PEL1 
                 PEL0 
               
               
                 VSCRDEF 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 1 
                 0 
                 0 
                 1 
                 1 
                 (33h) 
                 Vertical 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 scrolling 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 definition 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 TFA15 
                 TFA14 
                 TFA13 
                 TFA12 
                 TFA11 
                 TFA10 
                 TFA9 
                 TFA8 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 TFA7 
                 TFA6 
                 TFA5 
                 TFA4 
                 TFA3 
                 TFA2 
                 TFA1 
                 TFA0 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 VSA15 
                 VSA14 
                 VSA13 
                 VSA12 
                 VSA11 
                 VSA10 
                 VSA9 
                 VSA8 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 VSA7 
                 VSA6 
                 VSA5 
                 VSA4 
                 VSA3 
                 VSA2 
                 VSA1 
                 VSA0 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 BFA15 
                 BFA14 
                 BFA13 
                 BFA12 
                 BFA11 
                 BFA10 
                 BFA9 
                 BFA8 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 BFA7 
                 BFA6 
                 BFA5 
                 BFA4 
                 BFA3 
                 BFA2 
                 BFA1 
                 BFA0 
               
               
                 TEOFF 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 1 
                 0 
                 1 
                 0 
                 0 
                 (34h) 
                 Tearing 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 effect 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 line off 
               
               
                 TEON 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 1 
                 0 
                 1 
                 0 
                 1 
                 (35h) 
                 Tearing 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 effect 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 line on 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 TEM 
               
               
                 MADCTL 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 1 
                 0 
                 1 
                 1 
                 0 
                 (36h) 
                 Memory data 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 access 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 control 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 MY 
                 MX 
                 MV 
                 ML 
                 RGB 
                 0 
                 0 
                 0 
                   
                 — 
               
               
                 VSCRSADD 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 1 
                 0 
                 1 
                 1 
                 1 
                 (37h) 
                 Vertical 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 scrolling 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 start 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 address 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 VSP15 
                 VSP14 
                 VSP13 
                 VSP12 
                 VSP11 
                 VSP10 
                 VSP9 
                 VSP8 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 VSP7 
                 VSP6 
                 VSP5 
                 VSP4 
                 VSP3 
                 VSP2 
                 VSP1 
                 VSP0 
               
               
                 IDMOFF 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 1 
                 1 
                 0 
                 0 
                 0 
                 (38h) 
                 Idle mode 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 off 
               
               
                 IDMON 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 1 
                 1 
                 0 
                 0 
                 1 
                 (39h) 
                 Idle mode 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 on 
               
               
                 COLMOD 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 1 
                 1 
                 0 
                 1 
                 0 
                 (3Ah) 
                 Interface 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 pixel format 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 0 
                 D6 
                 D5 
                 D4 
                 0 
                 D2 
                 D1 
                 D0 
                   
                 Interface 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 format 
               
               
                 RAMWRC 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 1 
                 1 
                 1 
                 0 
                 0 
                 (3Ch) 
                 Memory write 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 continue 
               
               
                   
                 1 
                 ↑ 
                 1 
                 D1[17:8] 
                 D1[7] 
                 D1[6] 
                 D1[5] 
                 D1[4] 
                 D1[3] 
                 D1[2] 
                 D1[1] 
                 D1[0] 
                   
                 Write data 
               
               
                   
                 1 
                 ↑ 
                 1 
                 D1[17:8] 
                 Dx[7] 
                 Dx[6] 
                 Dx[5] 
                 Dx[4] 
                 Dx[3] 
                 Dx[2] 
                 Dx[1] 
                 Dx[0] 
               
               
                   
                 1 
                 ↑ 
                 1 
                 D1[17:8] 
                 Dn[7] 
                 Dn[6] 
                 Dn[5] 
                 Dn[4] 
                 Dn[3] 
                 Dn[2] 
                 Dn[1] 
                 Dn[0] 
               
               
                 RAMRDC 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 1 
                 1 
                 1 
                 1 
                 1 
                 0 
                 (3Eh) 
                 Memory read 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 continue 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy Read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 D1[17:8] 
                 D1[7] 
                 D1[6] 
                 D1[5] 
                 D1[4] 
                 D1[3] 
                 D1[2] 
                 D1[1] 
                 D1[0] 
               
               
                   
                 1 
                 1 
                 ↑ 
                 Dx[17:8] 
                 Dx[7] 
                 Dx[6] 
                 Dx[5] 
                 Dx[4] 
                 Dx[3] 
                 Dx[2] 
                 Dx[1] 
                 Dx[0] 
               
               
                   
                 1 
                 1 
                 ↑ 
                 Dn[17:8] 
                 Dn[7] 
                 Dn[6] 
                 Dn[5] 
                 Dn[4] 
                 Dn[3] 
                 Dn[2] 
                 Dn[1] 
                 Dn[0] 
               
               
                 TESCAN 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 1 
                 0 
                 0 
                 0 
                 1 
                 0 
                 0 
                 (44h) 
                 Set tear 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 scanline 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 N15 
                 N14 
                 N13 
                 N12 
                 N11 
                 N10 
                 N9 
                 N8 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 N7 
                 N6 
                 N5 
                 N4 
                 N3 
                 N2 
                 N1 
                 N0 
               
               
                 RDTESCAN 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 1 
                 0 
                 0 
                 0 
                 1 
                 0 
                 1 
                 (45h) 
                 Get 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 scanline 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy Read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 N9 
                 N8 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 N7 
                 N6 
                 N5 
                 N4 
                 N3 
                 N2 
                 N1 
                 N0 
               
               
                 WRDISBV 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 1 
                 0 
                 1 
                 0 
                 0 
                 0 
                 1 
                 (51h) 
                 Write display 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 brightness 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 DBV7 
                 DBV6 
                 DBV5 
                 DBV4 
                 DBV3 
                 DBV2 
                 DBV1 
                 DBV0 
               
               
                 RDDISBV 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 1 
                 0 
                 1 
                 0 
                 0 
                 1 
                 0 
                 (52h) 
                 Read display 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 brightness 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 value 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 DBV7 
                 DBV6 
                 DBV5 
                 DBV4 
                 DBV3 
                 DBV2 
                 DBV1 
                 DBV0 
               
               
                 WRCTRLD 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 1 
                 0 
                 1 
                 0 
                 0 
                 1 
                 1 
                 (53h) 
                 Write CTRL 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 display 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 0 
                 0 
                 BCTRL 
                 0 
                 DD 
                 BL 
                 0 
                 0 
               
               
                 RDCTRLD 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 1 
                 0 
                 1 
                 0 
                 1 
                 0 
                 0 
                 (54h) 
                 Read CTRL 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 value display 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 0 
                 0 
                 BCTRL 
                 0 
                 DD 
                 BL 
                 0 
                 0 
               
               
                 WRCACE 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 1 
                 0 
                 1 
                 0 
                 1 
                 0 
                 1 
                 (55h) 
                 Write content 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 adaptive 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 brightness 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 control and 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Color 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 enhancement 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 CECTRL 
                 0 
                 CE1 
                 CEO 
                 0 
                 0 
                 C1 
                 C0 
               
               
                 RDCABC 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 1 
                 0 
                 1 
                 0 
                 1 
                 1 
                 0 
                 (56h) 
                 Read 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 content 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 adaptive 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 brightness 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 control 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 0 
                 CECTRL 
                 0 
                 0 
                 0 
                 0 
                 C1 
                 C0 
               
               
                 WRCABCMB 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 1 
                 0 
                 1 
                 1 
                 1 
                 1 
                 0 
                 (5Eh) 
                 Write CABC 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 minimum 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 brightness 
               
               
                   
                 1 
                 ↑ 
                 1 
                 — 
                 CMB7 
                 CMB6 
                 CMB5 
                 CMB4 
                 CMB3 
                 CMB2 
                 CMB1 
                 CMB0 
               
               
                 RDCABCMB 
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 1 
                 0 
                 1 
                 1 
                 1 
                 1 
                 1 
                 (5Fh) 
                 Read CABC 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 minimum 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 brightness 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 CMB7 
                 CMB6 
                 CMB5 
                 CMB4 
                 CMB3 
                 CMB2 
                 CMB1 
                 CMB0 
               
               
                   
                 0 
                 ↑ 
                 1 
                 — 
                 0 
                 1 
                 1 
                 0 
                 1 
                 0 
                 0 
                 0 
                 (68h) 
                 Read 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Automatic 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Brightness 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Control 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Self- 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Diagnostic 
               
               
                 RDABCSDR 
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Result 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 D7 
                 D6 
                 0 
                 0 
                 0 
                 0 
                 0 
                 0 
                   
                 — 
               
               
                 RDID1 
                 0 
                 ↑ 
                 1 
                 — 
                 1 
                 1 
                 0 
                 1 
                 1 
                 0 
                 1 
                 0 
                 (DAh) 
                 Read ID1 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 ID17 
                 ID16 
                 ID15 
                 ID14 
                 ID13 
                 ID12 
                 ID11 
                 ID10 
                   
                 Read 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 parameter 
               
               
                 RDID2 
                 0 
                 ↑ 
                 1 
                 — 
                 1 
                 1 
                 0 
                 1 
                 1 
                 0 
                 1 
                 1 
                 (DBh) 
                 Read ID2 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 ID27 
                 ID26 
                 ID25 
                 ID24 
                 ID23 
                 ID22 
                 ID21 
                 ID20 
                   
                 Read 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 parameter 
               
               
                 RDID3 
                 0 
                 ↑ 
                 1 
                 — 
                 1 
                 1 
                 0 
                 1 
                 1 
                 1 
                 0 
                 0 
                 (DCh) 
                 Read ID3 
               
               
                   
                 1 
                 1 
                 ↑ 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                 — 
                   
                 Dummy read 
               
               
                   
                 1 
                 1 
                   
                 — 
                 ID37 
                 ID36 
                 ID35 
                 ID34 
                 ID33 
                 ID32 
                 ID31 
                 ID30 
                   
                 Read 
               
               
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                   
                 parameter 
               
               
                   
               
            
           
         
       
     
     Timer initialization code is as follows: 
     
       
         
           
               
             
               
                   
               
             
            
               
                 Timer2 
               
               
                     Fire Every 100Hz 
               
               
                 // Tell the Power Management Controller to disable 
               
               
                  // the write protection of the (Timer/Counter) registers: 
               
               
                  pmc_set_writeprotect(false); 
               
               
                  // Enable clock for the timer 
               
               
                  pmc_enable_periph_clk((uint32_t)t.irq); 
               
               
                  // Find the best clock for the wanted frequency 
               
               
                  clock = bestClock(frequency, rc); 
               
               
                  switch (clock) { 
               
               
                   case TC_CMR_TCCLKS_TIMER_CLOCK1: 
               
               
                    _frequency[timer] = (double)VARIANT_MCK / 2.0 / (double)rc; 
               
               
                    break; 
               
               
                   case TC_CMR_TCCLKS_TIMER_CLOCK2: 
               
               
                    _frequency[timer] = (double)VARIANT_MCK / 8.0 / (double)rc; 
               
               
                    break; 
               
               
                   case TC_CMR_TCCLKS_TIMER_CLOCK3: 
               
               
                    _frequency[timer] = (double)VARIANT_MCK / 32.0 / (double)rc; 
               
               
                    break; 
               
               
                   default: // TC_CMR_TCCLKS_TIMER_CLOCK4 
               
               
                    _frequency[timer] = (double)VARIANT_MCK / 128.0 / (double)rc; 
               
               
                    break; 
               
               
                  } 
               
               
                  // Set up the Timer in waveform mode which creates a PWM 
               
               
                  // in UP mode with automatic trigger on RC Compare 
               
               
                  // and sets it up with the determined internal clock as clock input. 
               
               
                  TC_Configure(t.tc, t.channel, TC_CMR_WAVE | TC_CMR_WAVSEL_UP_RC | 
               
               
                  // Reset counter and fire interrupt when RC value is matched: 
               
               
                  TC_SetRC(t.tc, t.channel, rc); 
               
               
                  // Enable the RC Compare Interrupt... 
               
               
                  t.tc−&gt;TC_CHANNEL[t.channel].TC_IER=TC_IER_CPCS; 
               
               
                  // ... and disable all others. 
               
               
                  t.tc−&gt;TC_CHANNEL[t.channel].TC_IDR=~TC_IER_CPCS; 
               
               
                 Timer3 
               
               
                     Fire Every 2000Hz 
               
               
                 Timer4 
               
               
                  Fire Every 100Hz 
               
               
                 // Tell the Power Management Controller to disable 
               
               
                  // the write protection of the (Timer/Counter) registers: 
               
               
                  pmcsetwriteprotect(false); 
               
               
                  // Enable clock for the timer 
               
               
                  pmc_enable_periph_clk((uint32_t)t.irq); 
               
               
                  // Find the best clock for the wanted frequency 
               
               
                  clock = bestClock(frequency, rc); 
               
               
                  switch (clock) { 
               
               
                   case TC_CMR_TCCLKS_TIMER_CLOCK1: 
               
               
                    _frequency[timer] = (double)VARIANT_MCK / 2.0 / (double)rc; 
               
               
                    break; 
               
               
                   case TC_CMR_TCCLKS_TIMER_CLOCK2: 
               
               
                    _frequency[timer] = (double)VARIANT_MCK / 8.0 / (double)rc; 
               
               
                    break; 
               
               
                   case TC_CMR_TCCLKS_TIMER_CLOCK3: 
               
               
                    _frequency[timer] = (double)VARIANT_MCK / 32.0 / (double)rc; 
               
               
                    break; 
               
               
                   default: // TC_CMR_TCCLKS_TIMER_CLOCK4 
               
               
                    _frequency[timer] = (double)VARIANT_MCK / 128.0 / (double)rc; 
               
               
                    break; 
               
               
                  } 
               
               
                  // Set up the Timer in waveform mode which creates a PWM 
               
               
                  // in UP mode with automatic trigger on RC Compare 
               
               
                  // and sets it up with the determined internal clock as clock input. 
               
               
                  TC_Configure(t.tc, t.channel, TC_CMR_WAVE | TC_CMR_WAVSEL_UP_RC | 
               
               
                  // Reset counter and fire interrupt when RC value is matched: 
               
               
                  TC_SetRC(t.tc, t.channel, rc); 
               
               
                  // Enable the RC Compare Interrupt... 
               
               
                  t.tc−&gt;TC_CHANNEL[t.channel].TC_IER=TC_IER_CPCS; 
               
               
                  // ... and disable all others. 
               
               
                  t.tc−&gt;TC_CHANNEL[t.channel].TC_IDR=~TC_IER_CPCS; 
               
               
                   
               
            
           
         
       
     
     The programming employed in the medical device  160  and application may include Atmel Studio tooling. Atmel Studio is an Integrated Development Environment (IDE) for writing and debugging AVR/ARM applications. Atmel Studio provides a project management tool, source file editor, simulator, assembler, and front-end for C/C++ programming, and on-chip debugging. Atmel Studio has a modular architecture, which allows interaction with third party software vendors. GUI plugins and other modules can be written and hooked to the system. 
     In addition to all the above requirements, there are a set of user requirements that are also needed. Table 14 provides a listing of these user requirements: 
     
       
         
           
               
             
               
                 TABLE 14 
               
             
            
               
                   
               
               
                 User requirements 
               
            
           
           
               
               
               
            
               
                 ID 
                 Description 
                 Comments 
               
               
                   
               
            
           
           
               
            
               
                 Quality of Audio Output 
               
            
           
           
               
               
               
            
               
                 1.1 
                 Audio output should be amplified to a 
                 Amplification factor of HealthyU speaker 
               
               
                   
                 degree where user can listen to the heart 
                 output is 6x. 
               
               
                   
                 and lung sounds with ease. 
               
               
                 1.2 
                 Device need to provide analog audio output 
                 Audio Jack in HealthyU device can be 
               
               
                   
                 for user to hear heart sounds 
                 connected to a smart device using a 
               
               
                   
                   
                 connector. This way user can listen to 
               
               
                   
                   
                 analog audio/heart sounds from the smart 
               
               
                   
                   
                 device. 
               
               
                 1.3 
                 ECG &amp; PCG waveform from the device 
                 HealthyU device shall be paired with smart 
               
               
                   
                 need to be printable 
                 device&#39;s Bluetooth via HealthyU app, print 
               
               
                   
                   
                 option from smart device shall be used to 
               
               
                   
                   
                 print ECG/PCG. 
               
               
                 1.4 
                 Heart sound sensed by device need to be 
                 Ambient noise rejection algorithm is used 
               
               
                   
                 immune to ambient noise 
                 to remove ambient noise impact in 
               
               
                   
                   
                 phonocardiogram 
               
               
                 1.5 
                 Clinician need to have access to heart 
                 HealthyU app is capable of recording the 
               
               
                   
                 sound data 
                 heart sounds that can be shared with 
               
               
                   
                   
                 clinician for diagnosis 
               
            
           
           
               
            
               
                 Visual Display Requirements 
               
            
           
           
               
               
               
            
               
                 2.1 
                 HealthyU device display needs to display 
                 Display necessary information in the device 
               
               
                   
                 the following, 
                 display to achieve intended device usage. 
               
               
                   
                 Time, Battery status, Firmware version 
               
               
                   
                 number and Label/icon of the vitals sent to 
               
               
                   
                 the HealthyU app 
               
               
                 2.2 
                 Authentic and dependable visual 
                 ECG and PCG waveforms shall be visible 
               
               
                   
                 representation of ECG and PCG waveforms 
                 on the smart device display in which 
               
               
                   
                   
                 application software is installed. Display 
               
               
                   
                   
                 should be a true representation of the 
               
               
                   
                   
                 cadence of the ECG/PCG. Display speed 
               
               
                   
                   
                 (Visual) and audio should be matched to 
               
               
                   
                   
                 each other. 
               
               
                 2.3 
                 App should enable ECG &amp; PCG amplitude 
                 Signal amplitude adjustment is required to 
               
               
                   
                 scaling option 
                 view ECG/PCG from patients of different 
               
               
                   
                   
                 physical constitution and cardiac 
               
               
                   
                   
                 conditions, clearly enough to identify the 
               
               
                   
                   
                 different phases and to derive conclusion. 
               
               
                 2.4 
                 Ability to visualize 3-4 cycles of ECG/PCG 
                 Display module of software is designed to 
               
               
                   
                 clearly without straining the eyes in the app 
                 accommodate at least 3-4 cycles of ECG &amp; 
               
               
                   
                 screen. 
                 PCG in the app device screen. 
               
               
                 2.5 
                 Ability to correlate “what you hear” to 
                 Display speed should be matched with the 
               
               
                   
                 “what you see” in real time 
                 audio and the waveform traced on the 
               
               
                   
                   
                 display should be in sync with the cadence 
               
               
                   
                   
                 of the audio, so that the user is able to 
               
               
                   
                   
                 correlate the display with the audio at any 
               
               
                   
                   
                 moment during auscultation 
               
               
                 2.6 
                 Ability to save the displayed ECG/PCG 
                 Application software shall record the 
               
               
                   
                 waveform 
                 ECG/PCG waveform automatically upon 
               
               
                   
                   
                 receiving signal from HealthyU device. 
               
               
                   
                   
                 User shall be able to save data so that it can 
               
               
                   
                   
                 be reviewed by both the user and physician 
               
               
                 2.7 
                 Ability to quickly assess typical 
                 Enables clinician to arrive at diagnosis and 
               
               
                   
                 pathologies by estimating position and 
                 treat the patients based on available vital 
               
               
                   
                 intensity of different waveforms visually 
                 data. 
               
               
                 2.8 
                 Display should be viewable under different 
                 Device may be used indoors as well as 
               
               
                   
                 lighting conditions 
                 outdoors, under bright natural light 
               
               
                   
                   
                 conditions as well as in dark areas, in 
               
               
                   
                   
                 addition to artificially illuminated areas- the 
               
               
                   
                   
                 display should be viewable without glare 
               
               
                   
                   
                 under expected lighting conditions 
               
               
                 2.9 
                 App display should provide some method 
                 Potential users require that ECG &amp; PCG be 
               
               
                   
                 of visually estimating the duration and 
                 displayed on grids with the same spacing as 
               
               
                   
                 amplitude of different ECG/PCG waveform 
                 ECG papers. This may reduce the learning 
               
               
                   
                 components 
                 curve, since doctors are trained to read the 
               
               
                   
                   
                 timing on such ECG papers by counting off 
               
               
                   
                   
                 the number of lines traversed by the 
               
               
                   
                   
                 waveform. 
               
               
                 2.10 
                 There should be options to maneuver 
                 Screens can be changed from APP controls. 
               
               
                   
                 between the various screens in the app 
               
            
           
           
               
            
               
                 Usability Requirements 
               
            
           
           
               
               
               
            
               
                 3.1 
                 Device should be easy to use and should 
                 Device usage should not involve complex 
               
               
                   
                 involve minimum learning curve to explore 
                 sequences of key presses. Keys and 
               
               
                   
                 complete set of features 
                 operations should be user friendly and need 
               
               
                   
                   
                 to be designed for the lay persons as 
               
               
                   
                   
                 intended user population 
               
               
                 3.2 
                 Device should be hand-held and operable 
                 Device need to be easy to carry and to 
               
               
                   
                 as a standalone device 
                 operate. 
               
               
                 3.3 
                 Device should be operated by rechargeable 
                 Device needs to be powered by 
               
               
                   
                 batteries 
                 rechargeable battery 
               
               
                 3.4 
                 Device should indicate whether the device 
                 To alert user about the battery status and to 
               
               
                   
                 is charging or if charging has been 
                 enable intended device usage and operating 
               
               
                   
                 completed 
                 time, battery status need to be displayed in 
               
               
                   
                   
                 the device 
               
               
                 3.5 
                 User should not have easy access to the 
                 To prevent battery associated hazards, built 
               
               
                   
                 battery compartment. 
                 in battery need to be provided 
               
               
                 3.6 
                 Batteries should last at least for 5 hours of 
                 To ensure home users can use the device for 
               
               
                   
                 operation between successive recharges 
                 at least 5 hours 
               
               
                 3.7 
                 Device should afford a simple cleaning 
                 Recommended cleaning method need to be 
               
               
                   
                 routine 
                 described in IFU. Simple cleaning routine 
               
               
                   
                   
                 suggested, making it easy for lay users 
               
               
                 3.8 
                 Button placement should be such that, any 
                 Button placement should be available for 
               
               
                   
                 movement to actuate the button should not 
                 thumb finger operation at all positions 
               
               
                   
                 occlude visibility of the display and button 
               
               
                   
                 usage should not introduce any motion 
               
               
                   
                 artifacts 
               
            
           
           
               
            
               
                 Form Factor Requirements 
               
            
           
           
               
               
               
            
               
                 4.1 
                 Device should be easy to carry, handle, 
                 Market feedback shows that the device 
               
               
                   
                 position and operate. 
                 weight should not exceed 200 grams, for 
               
               
                   
                   
                 ease of handling and for carrying 
               
               
                 4.2 
                 Device construction should be rugged and 
                 Temperature range at which the device can 
               
               
                   
                 should be suited for rough usage; device 
                 be transported, operated and stored shall be 
               
               
                   
                 parts like display module, 7-lead ECG etc. 
                 in compliance with IEC 60601-1 
               
               
                   
                 should be capable of withstanding 
                 Should meet requirements for mechanical 
               
               
                   
                 mechanical shocks due to fall, rough 
                 shocks per IEC 60601-1-11 and IEC 60601- 
               
               
                   
                 handling, varying temperatures in operating 
                 2-47 
               
               
                   
                 environment 
               
            
           
           
               
            
               
                 Information Supplied by the Manufacturer 
               
            
           
           
               
               
               
            
               
                 5.1 
                 Device should be supported by 
                 HealthyU shall come along with 
               
               
                   
                 comprehensive information material to aid 
                 comprehensive user manual/flipchart 
               
               
                   
                 users in the usage of HealthyU system. 
                 illustrating device handling, usage, caution 
               
               
                   
                   
                 and precaution. 
               
            
           
           
               
            
               
                 Interface Requirements 
               
            
           
           
               
               
               
            
               
                 6.1 
                 Interface to stream, captured ECG/PCG in 
                 Wireless communication 
               
               
                   
                 any laptop or smart device in which has 
               
               
                   
                 application software 
               
               
                 6.2 
                 Factory shall be able to update the 
                 Troubleshooting can also be done from 
               
               
                   
                 firmware. 
                 remote location 
               
            
           
           
               
            
               
                 Safety Requirements 
               
            
           
           
               
               
               
            
               
                 7.1 
                 Device should not be operable during 
                 Device shall enter standby mode when 
               
               
                   
                 battery charging, unless the charging is 
                 charging 
               
               
                   
                 through safe means that isolates the device 
               
               
                   
                 from the mains 
               
               
                 7.2 
                 Device shape and form factor should ensure 
                 Device should have curved edges 
               
               
                   
                 that it may not cause a safety hazard if it 
               
               
                   
                 accidentally falls on a person 
               
               
                 7.3 
                 Device usage should not interfere with 
                 Wireless Coexistence testing 
               
               
                   
                 operation of other medical device 160s in 
               
               
                   
                 the vicinity and device should in turn 
               
               
                   
                 remain unaffected when used in normal 
               
               
                   
                 operating environment 
               
               
                 7.4 
                 Device should not cause any safety hazard 
                 The components used in device should 
               
               
                   
                 to user or patient due to contact or due to 
                 meet all quality standards so as to ensure 
               
               
                   
                 the material used 
                 biocompatibility safety per ISO 10993-1 
               
               
                 7.5 
                 Device should not cause any safety hazard 
                 IEC 60601-1, clause 8 
               
               
                   
                 to user or patient due to electrical faults 
               
               
                 7.6 
                 Device should not cause any safety hazard 
                 IEC 60601-1 clause 11.1 
               
               
                   
                 to user or patient due to thermal faults 
               
               
                 7.7 
                 Device should not result in anomalous 
                 Watchdog timer that is operated by 
               
               
                   
                 behavior due to failure of the firmware. 
                 controller clock may to be used to restart 
               
               
                   
                 Should such an error occur, device should 
                 the system automatically, in case of any 
               
               
                   
                 shut down, restart or exit with error 
                 failure 
               
               
                   
                 message 
               
               
                 7.8 
                 Should pass the safety requirement tests 
                 Requirements identified in test plans, per 
               
               
                   
                   
                 IEC 60601-1, IEC 6001-1-2 and other 
               
               
                   
                   
                 applicable consensus standards listed in 
               
               
                   
                   
                 section 4. 
               
               
                 7.9 
                 Device should be ingress protected to 
                 Enclosures need to be designed to provide 
               
               
                   
                 ensure reliable use in intended use 
                 protection against harmful ingress per IEC 
               
               
                   
                 environment 
                 60601-1-11, clause 11.6.5. 
               
               
                   
               
            
           
         
       
     
     Table 15 provides software requirements: 
     
       
         
           
               
             
               
                 TABLE 15 
               
             
            
               
                   
               
               
                 Software Requirements 
               
            
           
           
               
               
               
            
               
                 SRD ID 
                 Specification 
                 Rationale/Reference 
               
               
                   
               
            
           
           
               
            
               
                 Functional Requirements 
               
            
           
           
               
               
               
            
               
                 SR001 
                 Operating system - Android 
                 Allow for use on smart 
               
               
                   
                   
                 device platforms 
               
               
                   
                   
                 A20 
               
               
                 SR002 
                 Minimum Screen resolution requirement of 
                 Display 3-4 cycles ECG &amp; 
               
               
                   
                 application software is 1280*800 pixels 
                 PCG clearly without eye 
               
               
                   
                   
                 strain 
               
               
                 SR003 
                 Auto pairing with HealthyU device via Bluetooth 
                 Upon starting the app, 
               
               
                   
                 Bluetooth icon is displayed on the screen during 
                 initiate Bluetooth pairing 
               
               
                   
                 launch of software application 
                 with HealthyU device 
               
               
                   
                   
                 using Bluetooth icon 
               
               
                   
                   
                 displayed on the 
               
               
                   
                   
                 application screen. 
               
               
                   
                   
                 A6 
               
               
                 SR004 
                 Bluetooth icon with toggle button to indicate 
                 Allow user to confirm 
               
               
                   
                 connectivity to HealthyU device 
                 Bluetooth connectivity 
               
               
                   
                 Toggle between blue and grey colors 
                 between the application 
               
               
                   
                 Blue indicates Bluetooth connectivity has 
                 and the HealthyU device, 
               
               
                   
                 been established 
                 as well as re-initiate 
               
               
                   
                 Grey indicates Bluetooth connectivity has not 
                 connectivity if lost. 
               
               
                   
                 been established 
                 A9, A14, A15, A23 
               
               
                   
                 Tapping on grey icon initiates Bluetooth 
               
               
                   
                 connection with HealthyU device 
               
               
                 SR005 
                 If there is only a single HealthyU device, that may 
                 User to select which 
               
               
                   
                 be selected automatically. 
                 HealthyU device to be 
               
               
                   
                 If there is more than one device detected 
                 paired 
               
               
                   
                 within Bluetooth Low Energy (BLE) range, all 
               
               
                   
                 the detected devices are listed by name and 
               
               
                   
                 MAC ID. User can select one of them. The 
               
               
                   
                 mac id to be labelled on the device 
               
               
                 SR006 
                 User can set default HealthyU device which 
                 Enable default Bluetooth 
               
               
                   
                 can be auto paired every time the app starts, 
                 pairing with user&#39;s 
               
               
                   
                 provided the device is ON and is in range. 
                 HealthyU device 
               
               
                   
                 The default device may be changed at any time 
               
               
                   
                 by the user. 
               
               
                 SR007 
                 HD Medical &amp; HealthyU logo displayed on top 
                 Identify app as a HD 
               
               
                   
                 left corner of app screen 
                 Medical product 
               
               
                 SR008 
                 Available device modes shall be: 
                 Allow user to select 
               
               
                   
                 Steth (HS &amp; ECG Channel 1) 
                 between device modes that 
               
               
                   
                 7-Channel ECG 
                 provide STETH (HS and 
               
               
                   
                   
                 single-channel ECG), 7- 
               
               
                   
                   
                 channel ECG functionality 
               
               
                   
                   
                 via separate app screens 
               
               
                 SR009 
                 STETH screen - PCG &amp; Channel 1 ECG 
                 Provide a main viewing 
               
               
                   
                 Auscultation waveform plotting shall be displayed 
                 screen upon starting the 
               
               
                   
                 on landing screen, following successful Bluetooth 
                 app. 
               
               
                   
                 pairing with HealthyU device. 
               
               
                 SR010 
                 7-channel Screen 
                 Allow user to view 7- 
               
               
                   
                   
                 channel ECG in the app 
               
               
                 SR011 
                 Option to rename the ECG channels labels using 
                 Allow user to rename the 
               
               
                   
                 settings 
                 ECG labels 
               
               
                 SR012 
                 Heart Sound data (PCG) shall be depicted as a blue 
                 View heart sound data as 
               
               
                   
                 waveform (default). Waveform color can be 
                 PCG waveform 
               
               
                   
                 changed by the user via the user-configurable 
               
               
                   
                 Settings 
               
               
                 SR013 
                 ECG waveform shall be depicted as a green 
                 View ECG waveform 
               
               
                   
                 waveform (default) with an ECG grid which 
               
               
                   
                 appears by default. 
               
               
                 SR014 
                 In HealthyU auscultation screen, indications for 
                 Allow user to measure 
               
               
                   
                 measurements of waveform by default are given as, 
                 ECG &amp; PCG waveforms 
               
               
                   
                 major axis = 5 mm 
                 manually 
               
               
                   
                 Duration: 25 mm/S 
               
               
                   
                 Amplitude: 10 mm/mV 
               
               
                   
                 Above items may be indicated graphically. 
               
               
                 SR015 
                 All 7 channel ECG waveforms shall be 
                 Allow user to view all 7 
               
               
                   
                 accommodated in a single screen. 
                 channel ECG waveforms 
               
               
                   
                   
                 on a single screen 
               
               
                 SR016 
                 Vertical scroll bar in right side of the screen 
                 For user to view specific 
               
               
                   
                   
                 waveform by scrolling up 
               
               
                   
                   
                 or down throughout the 7- 
               
               
                   
                   
                 channel screen 
               
               
                 SR017 
                 Add study button is present in both Steth &amp; 7- 
                 To associate ECG &amp; PCG 
               
               
                   
                 channel screen to add user details of the present 
                 data with respective user 
               
               
                   
                 study 
               
               
                 SR018 
                 User name and id of the present study may be 
                 To associate recorded data 
               
               
                   
                 displayed on the app screen. 
                 with correct user 
               
               
                 SR019 
                 Record button present in both Steth &amp; 7-channel 
                 Function to enable the 
               
               
                   
                 screen to initiate recording 
                 saving the ECG &amp; PCG 
               
               
                   
                   
                 waveforms 
               
               
                 SR020 
                 The recording duration measured in seconds can 
                 User configurable setting 
               
               
                   
                 be configured (10 sec, 20 sec, 30 sec up to 120 
               
               
                   
                 sec.) by user via settings. Default is 10 seconds. 
               
               
                 SR021 
                 While recording is in-progress all other buttons in 
                 Disable all other app 
               
               
                   
                 the screen shall be inactive, the record button 
                 button functions during 
               
               
                   
                 should get replaced by a progress bar that may 
                 recording to avoid 
               
               
                   
                 indicate the progress of the recording. 
                 unintentional interruption 
               
               
                   
                   
                 A16 
               
               
                 SR022 
                 Freeze button in both Steth &amp; 7-channel screen to 
                 Function to 
               
               
                   
                 enable screen capturing 
                 instantaneously screen 
               
               
                   
                   
                 capture the live waveforms 
               
               
                 SR023 
                 Screenshot may be saved to patient record/worklist 
                 Button to take screenshot 
               
               
                   
                   
                 of the real time displayed 
               
               
                   
                   
                 data 
               
               
                 SR024 
                 Add/exit study button is present in both Steth and 
                 To associate recorded data 
               
               
                   
                 7 channel screen for user to switch between 
                 with correct user 
               
               
                   
                 multiple user profiles and enable user to store or 
               
               
                   
                 link data with correct user profile. 
               
               
                 SR025 
                 A toggle icon to switch between Steth screen and 
                 For user to view the 7 
               
               
                   
                 7-channel screen in the app screen 
                 channel ECG screen &amp; 
               
               
                   
                   
                 Steth screen 
               
               
                 SR026 
                 Once recording duration is completed, user 
                 Allows user to preview 
               
               
                   
                 may be taken to preview screen, in the 
                 both 
               
               
                   
                 preview screen, data of Steth (PCG and 
                 Steth screen data and 7 
               
               
                   
                 Channel 1 ECG), or 7 Channel ECG screen 
                 channel ECG data together 
               
               
                   
                 may be displayed. 
               
               
                 SR027 
                 After checking the preview screen, user can 
                 Enables user to save or 
               
               
                   
                 either choose to save or discard the data 
                 discard the data displayed 
               
               
                   
                 shown in preview using save or discard 
                 in the preview screen 
               
               
                   
                 button displayed in the preview screen. 
               
               
                 SR028 
                 While preview screen is in active state, recording 
                 Enables user to save or 
               
               
                   
                 of data may not occur &amp; the recorded waveforms 
                 discard the data displayed 
               
               
                   
                 may be displayed on the Steth or 7 channel ECG 
                 in the preview screen 
               
               
                   
                 screen as recorded. 
               
               
                 SR029 
                 If user chooses to save the data displayed in the 
                 Provide “save” button to 
               
               
                   
                 preview screen, user may be directed to choose 
                 allow user to save 
               
               
                   
                 whether the data has to be saved to a new patient 
                 recorded data for either a 
               
               
                   
                 or existing patient 
                 new or existing patient 
               
               
                 SR030 
                 New Patient: 
                 Allow user to create new 
               
               
                   
                 Add new patient profile. After saving current 
                 patient profile when 
               
               
                   
                 recording, the program shall lead to Patient 
                 saving recorded data for a 
               
               
                   
                 History containing list of recordings. 
                 new patient 
               
               
                 SR031 
                 Existing Patient: 
                 Allow user to choose from 
               
               
                   
                 Display a screen with list of patients. User shall be 
                 existing patient profiles 
               
               
                   
                 able to search and identify a patient to save the 
                 when saving recorded data 
               
               
                   
                 current recording. 
                 for an existing patient 
               
               
                 SR032 
                 Discard the temporarily stored recording and move 
                 Allow user to discard 
               
               
                   
                 to the Steth screen so that the user can proceed to 
                 current recording and 
               
               
                   
                 conduct a new recording. 
                 initiate new recording 
               
               
                   
                 Require user confirmation before performing this 
               
               
                   
                 action. 
               
               
                 SR033 
                 Viewing patient record from patient files: 
                 Retrievable and accessible 
               
               
                   
                 User shall be able to view the history of patient 
                 patient records 
               
               
                   
                 recording including patient personal data and 
               
               
                   
                 ECG, PCG and vitals by tapping the patient 
               
               
                   
                 history/worklist button. 
               
               
                 SR034 
                 While viewing recorded data from the worklist, the 
                 Allow user to listen to 
               
               
                   
                 PCG sound should be audible on the user device 
                 playback of PCG sound on 
               
               
                   
                 (example: Tablet, Mobile or laptop). 
                 their device 
               
               
                 SR035 
                 Settings button in Steth &amp; 7-channel screen 
                 To access settings screen 
               
               
                 SR036 
                 Button to access patient record in both Steth &amp; 7- 
                 To access patient records 
               
               
                   
                 channel screen 
                 from main screen 
               
               
                 SR037 
                 A device info button to provide smart device 
                 Smart device 
               
               
                   
                 specification 
                 specifications 
               
               
                 SR038 
                 Device placement guidelines to be displayed in 
                 To guide user 
               
               
                   
                 app on the splash screen 
               
               
                 SR039 
                 Firmware version displayed in app screen 
                 Firmware information 
               
               
                   
                   
                 A27 
               
               
                 SR040 
                 HealthyU device battery status is displayed in app 
                 To enable user to monitor 
               
               
                   
                   
                 device battery status while 
               
               
                   
                   
                 device is in use 
               
               
                 SR041 
                 Select posture &amp; select position screen appears 
                 To acquire information on 
               
               
                   
                 after recording duration 
                 user posture and device 
               
               
                   
                   
                 positioning 
               
               
                 SR042 
                 Permission requesting smart device resources 
                 To enable app&#39;s access to 
               
               
                   
                 window appear when the app is launched first time 
                 smart device, android 
               
               
                   
                   
                 requirement 
               
               
                 SR043 
                 Patient report is generated in PDF format. PDF has 
                 To enable sharing and 
               
               
                   
                 both PHI and PII 
                 printing 
               
               
                 SR044 
                 Receives channel 1 (lead I), channel 2 (lead II) and 
                 To display 7-channel ECG 
               
               
                   
                 channel 7 (lead V) data from firmware 
               
               
                 SR045 
                 Augmented waveforms (channel 4 (aVF), channel 
                 To display 7-channel ECG 
               
               
                   
                 5 (aVL),channel 6 (aVR) and channel 3 (Lead III) 
               
               
                   
                 are derived in software 
               
            
           
           
               
               
               
               
            
               
                 SR046 
                 Channel 
                 Configuration 
                 Channel and its 
               
               
                   
                 Channel 1 
                 LA − RA 
                 configuration 
               
               
                   
                 Channel 2 
                 LL − RA 
               
               
                   
                 Channel 3 
                 Channel 2 − Channel 1 
               
               
                   
                 Channel 4 
                 −(Channel 1 + Channel 2)/2 
               
               
                   
                 Channel 5 
                 Channel 1 − channel 2/2 
               
               
                   
                 Channel 6 
                 Channel 2 − Channel 1/2 
               
               
                   
                 Channel 7 
                 Electrode 1 − 
               
               
                   
                   
                 (RA + LA + Electrode 2)/3 
               
            
           
           
               
               
               
            
               
                 SR047 
                 Heart rate is calculated after the recorded signal is 
                 To display heart rate in 
               
               
                   
                 saved by the user 
                 patient file 
               
               
                 SR048 
                 Heart rate is displayed in patient file generated in 
                 To display heart rate in 
               
               
                   
                 PDF format 
                 patient file 
               
               
                 SR049 
                 HR filter shall be used for HR calculation 
                 To calculate heart rate 
               
               
                   
                   
                 A19 
               
               
                 SR050 
                 ECG and PCG can be replayed after saving them 
                 To replay saved ECG and 
               
               
                   
                   
                 PCG 
               
               
                 SR051 
                 First time users need to register their device 
                 To generate customer code 
               
               
                   
                 following the onscreen instruction. 
                 and database 
               
               
                   
                   
                 A10 
               
               
                 SR052 
                 If smart device battery is low, a message is 
                 To inform user to ensure 
               
               
                   
                 displayed, recommending user to charge the smart 
                 continuous device usage 
               
               
                   
                 device 
                 A31 
               
               
                 SR053 
                 Amplitude scaling option in steth screen 
                 To vertically zoom PCG 
               
               
                   
                   
                 and channel 1 ECG 
               
               
                 SR054 
                 Heart rate range is between 30 to 250 bpm 
                 To use for patients ≥10 Kg 
               
               
                 SR055 
                 Accuracy of heart rate measurement need to be ±5 
                 To ensure integrity 
               
               
                   
                 bpm 
               
               
                 SR056 
                 App should be designed for lay users 
                 To ensure easy usability 
               
               
                   
                   
                 experience for lay users 
               
               
                   
                   
                 A29 
               
               
                 SR057 
                 Registration module for user to register their 
                 Product maintenance 
               
               
                   
                 HealthyU device with HD Medical, Inc. 
               
               
                 SR058 
                 Device placement position (Aortic, Pulmonary 
                 Map the electrode 
               
               
                   
                 Tricuspid, Mitral, V1 to V6) and user posture 
                 locations with ECG 
               
               
                   
                 (sitting, standing, supine) information to be 
                 acquired and user posture 
               
               
                   
                 entered by user for each recording 
               
            
           
           
               
            
               
                 Minimum requirements of HealthyU app to run on Android platforms 
               
            
           
           
               
               
               
            
               
                 SR044 
                 Processor requirement is Snapdragon 425 or 
                 Enable app to achieve its 
               
               
                   
                 equivalent or faster processor family 
                 intended use 
               
               
                 SR045 
                 Memory requirement is minimum 2 GB RAM 
                 To allow app performance 
               
               
                 SR046 
                 Storage requirement is 10 GB or above 
                 To store patient data 
               
               
                   
                   
                 locally in the smart device 
               
               
                   
                   
                 A13 
               
               
                 SR047 
                 Screen size - 8 inch 
                 Allow data reproducibility 
               
               
                   
                   
                 in real time 
               
               
                 SR048 
                 Bluetooth 5.0 (BLE) &amp; above 
                 Allow auto Bluetooth 
               
               
                   
                   
                 pairing of device &amp; app 
               
               
                 SR049 
                 Android 9.0 or above 
                 Enable app to achieve its 
               
               
                   
                   
                 intended use 
               
               
                 SR050 
                 Smart device with audio jack 
                 To playback the recorded 
               
               
                   
                   
                 PCG 
               
               
                 SR051 
                 Wi-Fi &amp; GPS to enable user registration &amp; to 
                 Enable app to achieve its 
               
               
                   
                 download app from play store 
                 intended use 
               
            
           
           
               
            
               
                 Patient Profile 
               
            
           
           
               
               
               
            
               
                 SR101 
                 Provide general patient details - First name, Last 
                 Allow user to enter patient 
               
               
                   
                 name, patient id, Gender, Date of birth, Contact 
                 information. 
               
               
                   
                 Information. All these items are mandatory. 
                 A33 
               
               
                 SR102 
                 Date of Birth should be entered using Calendar 
                 Allow user to enter date of 
               
               
                   
                 option. Invalid dates should be indicated 
                 birth using calendar 
               
               
                   
                 appropriately. Manual entering is not allowed. 
                 selection. 
               
               
                 SR103 
                 Age is calculated from the date of birth and 
                 Allow user to view age of 
               
               
                   
                 displayed. It shall not be editable directly. 
                 patient as calculated from 
               
               
                   
                   
                 date of birth. 
               
               
                 SR104 
                 Gender options - Male, Female and Other shall be 
                 Allow gender selections as 
               
               
                   
                 available in the form of Radio buttons. 
                 male, female, or other. 
               
               
                 SR105 
                 Remainder of fields for patient address, phone and 
                 Allow text entry for 
               
               
                   
                 email information are text data. 
                 patient contact info fields. 
               
               
                 SR106 
                 Fields such as height, weight, blood pressure, 
                 Allow for optional fields 
               
               
                   
                 temperature, hemoglobin, blood glucose, oxygen 
                 that do not require user 
               
               
                   
                 saturation under history section are optional fields. 
                 data entry. 
               
               
                   
                 User can keep these fields as blank and save 
               
               
                   
                 Patient&#39;s profile. 
               
               
                 SR107 
                 Patient id to be set by user 
                 Used as unique record 
               
               
                   
                   
                 identifier 
               
            
           
           
               
            
               
                 Patient Files &amp; Demo Video 
               
            
           
           
               
               
               
            
               
                 SR201 
                 Demo video of how to operate HealthyU 
                 Allow user to easily 
               
               
                   
                 application is provided 
                 understand HealthyU 
               
               
                   
                   
                 operation or usage 
               
               
                 SR202 
                 Patient Files: 
                 List existing saved patient 
               
               
                   
                 Patients with latest saved recordings appear on top. 
                 recordings for selection 
               
               
                   
                 The search option is available to look for a patient 
                 and allow ability to search 
               
               
                   
                 by entering name or patient ID or contact number. 
                 on patient ID. 
               
               
                 SR203 
                 On choosing a patient, the history of all recordings 
                 Allow user to view patient 
               
               
                   
                 for that patient, identifiable by their timestamp, 
                 history and identify 
               
               
                   
                 shall be produced. The most recent recordings 
                 recordings by timestamp 
               
               
                   
                 shall appear on top. 
               
               
                 SR204 
                 On tapping patient record, the particular 
                 Allow user to view 
               
               
                   
                 records may be displayed on the viewing 
                 specific recording by 
               
               
                   
                 screen. 
                 tapping patient record 
               
               
                 SR205 
                 The patient name &amp; time stamp shall appear on the 
                 Allow user to easily view 
               
               
                   
                 top row of the patient record. 
                 patient name and 
               
               
                   
                   
                 timestamp for each 
               
               
                   
                   
                 recording 
               
               
                   
               
            
           
         
       
     
     A patient profile is generated for each user of the system. When saving a recording to a new patient from the Preview screen, a patient profile screen, as seen in  FIGS. 34-36 , at  3400 ,  3500 , and  3600 , respectively, is displayed. This screen consists of three sections: 1) Profile—This section has fields for entering the general details of the patient like Name, Date of Birth, Gender, Contact details and medical history. Patient Id shall be automatically generated once the registration process is completed; 2) History—The medical history of the patient can be stored in this section. This is optional information to be stored in the app for accurate prognosis by clinician; and 3) Contact Details—User contact details such as phone number, address are entered here. 
     Turning back to the hardware components of the medical device  160 , The microcontroller is a Flash microcontroller based on the high performance 32-bit ARM Cortex-M3 RISC processor. It operates at a maximum speed of 84 MHz and features up to 512 Kbytes of Flash and up to 100 Kbytes of SRAM. The peripheral set includes a Highspeed USB Host and Device port with embedded transceiver, an Ethernet MAC, 2 CANs, a Highspeed MCI for SDIO/SD/MMC, an External Bus Interface with NAND Flash Controller (NFC), 5 UARTs, 2 TWIs, 4 SPIs, as well as a PWM timer, 3-channel general-purpose 32-bit timers, a low-power RTC, a low power RTT, 256-bit General Purpose Backup Registers, a 12-bit ADC. The microcontroller architecture is specifically designed to sustain high-speed data transfers. It includes a multi-layer bus matrix as well as multiple SRAM banks, PDC and DMA channels that enable it to run tasks in parallel and maximize data throughput. The device operates at 3.3V and is available in 144-lead LQFP, LFBGA packages. 
     Pin mapping for this type of microcontroller may be seen below in Table 16: 
     
       
         
           
               
             
               
                 TABLE 16 
               
             
            
               
                   
               
               
                 Microcontroller Pin Mapping 
               
            
           
           
               
               
               
            
               
                 SAM3X Pin Name 
                 Mapped Pin Name 
                 As Per Schematic 
               
               
                   
               
               
                 PA8 
                 RX0 
                 RXD0 
               
               
                 PA9 
                 TX0 
                 TXD0 
               
               
                 PB25 
                 Digital Pin 2 
                 BT_AUTORUNn 
               
               
                 PC28 
                 Digital Pin 3 
                 CHARG_STATUS 
               
               
                 connected to both 
                 Digital Pin 4 
                 ECG_SPIO_CSn 
               
               
                 PA29 and PC26 
               
               
                 PC25 
                 Digital Pin 5 
                 DRDYBn 
               
               
                 PC24 
                 Digital Pin 6 
                 BUZZER 
               
               
                 PC23 
                 Digital Pin 7 
                 C23 (TP) 
               
               
                 PC22 
                 Digital Pin 8 
                 LCD_RESET 
               
               
                 PC21 
                 Digital Pin 9 
                 LCD_DC 
               
               
                 PA28 and PC29 
                 Digital Pin 10 
                 LCD_CS 
               
               
                 PD7 
                 Digital Pin 11 
                 LCD_MOSI 
               
               
                 PD8 
                 Digital Pin 12 
                 Freeze_SW 
               
               
                 PB27 
                 Digital Pin 13/Amber 
                 LCD_SPCK 
               
               
                   
                 LED “L” 
               
               
                 PD4 
                 TX3 
                 TXD3 
               
               
                 PD5 
                 RX3 
                 RXD3 
               
               
                 PA13 
                 TX2 
                 TXD2 
               
               
                 PA12 
                 RX2 
                 RXD2 
               
               
                 PA11 
                 TX1 
                 BT_UART_TXD 
               
               
                 PA10 
                 RX1 
                 BT_UART_RXD 
               
               
                 PB12 
                 SDA 
                 SPO2_SDA 
               
               
                 PB13 
                 SCL 
                 SPO2_SCL 
               
               
                 PB26 
                 Digital Pin 22 
                 PHP_RSTn 
               
               
                 PA14 
                 Digital Pin 23 
                 NC 
               
               
                 PA15 
                 Digital Pin 24 
                 NC 
               
               
                 PD0 
                 Digital Pin 25 
                 MFIO_2 
               
               
                 PD1 
                 Digital pin 26 
                 RESET_2 
               
               
                 PD2 
                 Digital Pin 27 
                 D2 (TP) 
               
               
                 PD3 
                 Digital Pin 28 
                 D3 (TP) 
               
               
                 PD6 
                 Digital Pin 29 
                 D6 (TP) 
               
               
                 PD9 
                 Digital Pin 30 
                 NC 
               
               
                 PA7 
                 Digital Pin 31 
                 PA7 (TP) 
               
               
                 PD10 
                 Digital Pin 32 
                 D10 (TP) 
               
               
                 PC1 
                 Digital Pin 33 
                 EN_PCG_3V3A 
               
               
                 PC2 
                 Digital Pin 34 
                 uP_Force Off 
               
               
                 PC3 
                 Digital Pin 35 
                 EN_SPO2_1V8D 
               
               
                 PC4 
                 Digital Pin 36 
                 uP_ON/OFF 
               
               
                 PC5 
                 Digital Pin 37 
                 AMP_SHUTN 
               
               
                 PC6 
                 Digital Pin 38 
                 C6 (TP) 
               
               
                 PC7 
                 Digital Pin 39 
                 C7 (TP) 
               
               
                 PC8 
                 Digital Pin 40 
                 C8 (TP) 
               
               
                 PC9 
                 Digital Pin 41 
                 C9 (TP) 
               
               
                 PA19 
                 Digital Pin 42 
                 NC 
               
               
                 PA20 
                 Digital Pin 43 
                 NC 
               
               
                 PC19 
                 Digital Pin 44 
                 NC 
               
               
                 PC18 
                 Digital Pin 45 
                 NC 
               
               
                 PC17 
                 Digital Pin 46 
                 NC 
               
               
                 PC16 
                 Digital Pin 47 
                 NC 
               
               
                 PC15 
                 Digital Pin 48 
                 NC 
               
               
                 PC14 
                 Digital Pin 49 
                 NC 
               
               
                 PC13 
                 Digital Pin 50 
                 NC 
               
               
                 PC12 
                 Digital Pin 51 
                 NC 
               
               
                 PB21 
                 Digital Pin 52 
                 NC 
               
               
                 PB14 
                 Digital Pin 53 
                 NC 
               
               
                 PA16 
                 Analog In 0 
                 A0 (TP) 
               
               
                 PA24 
                 Analog In 1 
                 A1 (TP) 
               
               
                 PA23 
                 Analog In 2 
                 A2 (TP) 
               
               
                 PA22 
                 Analog In 3 
                 A3 (TP) 
               
               
                 PA6 
                 Analog In 4 
                 EN_LCD_3V3D 
               
               
                 PA4 
                 Analog In 5 
                 BATT_MONITOR 
               
               
                 PA3 
                 Analog In 6 
                 ANR_AFE 
               
               
                 PA2 
                 Analog In 7 
                 PCG_AFE 
               
               
                 PB17 
                 Analog In 8 
                 EN_BT_ECG_3V3D 
               
               
                 PB18 
                 Analog In 9 
                 EN_SPO2_3V3D 
               
               
                 PB19 
                 Analog In 10 
                 RESET 
               
               
                 PB20 
                 Analog In 11 
                 MFIO 
               
               
                 PB15 
                 DAC0 
                 DAC0 (CANRX1) (TP) 
               
               
                 PB16 
                 DAC1 
                 DAC1 
               
               
                 PA1 
                 CANRX 
                 CANRX0 
               
               
                 PA0 
                 CANTX 
                 CANTX0 
               
               
                 PA17 
                 SDA1 
                 TEMP_SDA 
               
               
                 PA18 
                 SCL2 
                 TEMP_SCL 
               
               
                 PC30 
                 LED “RX” 
                 C30 (TP) 
               
               
                 PA21 
                 LED “TX” 
                 PA21 (TP) 
               
               
                 PA25 
                 (MISO) 
                 ECG_SPI0_MISO 
               
               
                 PA26 
                 (MOSI) 
                 ECG_SPI0_MOSI 
               
               
                 PA27 
                 (SCLK) 
                 ECG_SPI0_CLK 
               
               
                 PA28 
                 (NPCS0) 
                 LCD_CS 
               
               
                 PB23 
                 (unconnected) 
                 NC 
               
               
                 PB11 
                 ID 
                 NC 
               
               
                 PB10 
                 VBOF 
                 NC 
               
               
                 PC10 
                   
                 C10 (TP) 
               
               
                 PC30 
                   
                 C30 (TP) 
               
               
                   
               
            
           
         
       
     
     The Microcontroller product has several types of power supply pins: VDDIO pins: Power the peripherals I/O lines: voltage range +3.3 v; VDDIN pin: Powers the voltage regulator: voltage range +3.3 v; VDDBU pin: Powers the Slow Clock oscillator and a part of the System Controller; voltage range of +3.3V. VDDBU should be supplied before or at the same time as VDDIO and VDDCORE; VDDUTMI pin: Powers the UTMI+ interface: voltage range of 3.3V; VDDANA pin: Powers the ADC and DAC cells; voltage range of 3.3V; VDDOUT pin: Output of the voltage regulator; VDDCORE pins: Power the core, the embedded memories and the peripherals; pin: Powers the PLL A, UPLL and 3-20 MHz Oscillator. 
     Ground pins GND are common to VDDCORE and VDDIO pins power supplies. Separated ground pins are provided for VDDBU, VDDPLL, VDDUTMI and VDDANA. These ground pins are respectively GNDBU, GNDPLL, GNDUTMI and GNDANA. 
     The Power Supply Controller controls the power supplies of the processor and peripherals via Voltage regulator control. The Supply Controller has its own reset circuitry and is clocked by the 32 kHz Slow clock generator. The reset circuitry is based on a zero-power power-on reset cell. The zero-power power-on reset allows the Supply Controller to start properly. 
     The Power-on-Reset monitors VDDBU. It is always activated and monitors voltage at start up but also during power down. If VDDBU goes below the threshold voltage, the entire chip is reset. The Brownout Detector monitors VDDCORE. It is active by default. It can be deactivated by software through the Supply Controller (SUPC_MR). It is especially recommended to disable it during low-power modes such as wait or sleep modes. If VDDCORE goes below the threshold voltage, the reset of the core is asserted. The Supply Monitor monitors VDDUTMI. It is not active by default. It can be activated by software and is fully programmable with 16 steps for the threshold (between 1.9V to 3.4V). It is controlled by the Supply Controller (SUPC). A sample mode is possible. It allows to divide the supply monitor power consumption by a factor of up to 2048. 
     Clock inputs include: A Low Power 32.768 KHz Slow Clock Oscillator with bypass mode; A Low Power RC Oscillator; A 3 to 20 MHz Crystal or Ceramic Resonator-based Oscillator, which can be bypassed; A 480 MHz UTMI PLL, providing a clock for the USB High Speed Controller; A 96 to 192 MHz programmable PLL (input from 8 to 16 MHz), capable of providing the clock MCK to the processor and to the peripherals. 
     In the 5-Lead ECG shown in  FIG. 37  at  3700 , the medical device  160  uses the Common-Mode Detector to measure the common-mode of the system by averaging the voltage of input pins IN 1 , IN 2  and IN 3 , and uses this signal in the right-leg drive feedback circuit. The output of the RLD amplifier is connected to RL through IN 4  to drive the common-mode of the system. The Wilson Central Terminal is generated by the medical device  160  and is used as a reference to measure the chest electrode, V1. The chip uses an external 4.096 MHz crystal oscillator connected between the XTAL1 and XTAL2 pins to create the clock source for the device. 
     The ECG signals are captured using 5 electrodes placed on circular board. OPA2335 &amp; High pass filter rectifies the signal capture by electrodes and medical device  160  filters the signal and send to microcontroller through SPI channel for digital signal processing. The Serial Peripheral Interface (SPI) circuit is a synchronous serial data link that provides communication with MEDICAL DEVICE  160  devices in Master or Slave Mode. It also enables communication between controller with analog front end for biopotential. Master Out Slave In (MOSI): This data line supplies the output data from the master (microcontroller) shifted into the input(s) of the slave (ADS12923). Master In Slave Out (MISO): This data line supplies the output data from a slave (medical device  160 ) to the input of the master (microcontroller). There may be no more than one slave transmitting data during any particular transfer. Serial Clock (SPCK): This control line is driven by the master and regulates the flow of the data bits. The master may transmit data at a variety of baud rates; the SPCK line cycles once for each bit that is transmitted. Slave Select (NSS): This control line allows slave to be turned on and off by hardware. Pin mapping for the SPI is shown on Table 17 below: 
     
       
         
           
               
             
               
                 TABLE 17 
               
             
            
               
                   
               
               
                 SPI Pin Mapping 
               
            
           
           
               
               
               
               
            
               
                 MEDICAL 
                   
                 MICRO- 
                   
               
               
                 DEVICE 
                   
                 CONTROLLER 
               
               
                 160 pin 
                 Function 
                 pin 
                 Function 
               
               
                   
               
               
                 19 
                 Serial Data Output 
                 PA25 
                 ECG SPI0 MISO 
               
               
                   
                 (SPI0) 
               
               
                 18 
                 Serial Data Input 
                 PA26 
                 ECG SPI0 MOSI 
               
               
                   
                 (SPI0) 
               
               
                 17 
                 Serial Clock (SPI0) 
                 PA27 
                 ECG SPI0 Clock 
               
               
                 16 
                 Chip Select Bar 
                 PA29 
                 ECG SPI0 Chip 
               
               
                   
                 (SPI0) 
                   
                 Select 
               
               
                   
               
            
           
         
       
     
     OPA2335 is a CMOS operational amplifier used as a buffer amplifier to provide low offset voltage 5uv(MAX). OPA2335 is operates at 3.3 v(VCC_3 v3A). The amplified signal is fed into high pass filter to rectify the signal. 
     Medical device  160  analog front end connect with ARM core over SPI channel. Sampling rate of medical device  160  is 160±5 Hz. Basic features of MEDICAL DEVICE  160  implemented for our applications are: Three High-Resolution Digital ECG Channels; Data Rate: Up to 25.6 ksps; Built-In Oscillator and Reference; AC and DC Lead-Off Detection. ECG Pin mapping is illustrated below in Table 18: 
     
       
         
           
               
             
               
                 TABLE 18 
               
             
            
               
                   
               
               
                 ECG Pin Mapping 
               
               
                 ECG PIN Mapping 
               
            
           
           
               
               
               
               
            
               
                   
                   
                 Mapped Pin 
                 As Per 
               
               
                   
                 SAM3X Pin Name 
                 Name 
                 Schematic 
               
               
                   
                   
               
               
                   
                 PA25 
                 (MISO) 
                 ECG_SPI0_MISO 
               
               
                   
                 PA26 
                 (MOSI) 
                 ECG_SPI0_MOSI 
               
               
                   
                 PA27 
                 (SCLK) 
                 ECG_SPI0_CLK 
               
               
                   
                 connected to 
                 Digital Pin 4 
                 ECG_SPI0_CSn 
               
               
                   
                 both PA29 and PC26 
               
               
                   
                 PC25 
                 Digital Pin 5 
                 DRDYBn 
               
               
                   
                   
               
            
           
         
       
     
     Layout consideration &amp; supply filtering for the medical device  160  includes: Used 0.1 uF/16V ceramic bypass capacitor from Analog Supply Voltage (VDD) to ground as close as possible to the pin; Used 0.1 uF/16V ceramic bypass capacitor from Digital Supply Voltage (VDDIO) to ground as close as possible to the pin; Used a low ESR 1 uF/16V bypass capacitor from CVREF pin to ground as close as possible to the pin; Used a low ESR 0.1 uF/16V bypass capacitor from RLDREF pin to ground as close as possible to the pin; The SPI signal traces routed close together; 49.9E Series resistors are placed at SDO and DRDYB pins of medical device  160 . 
     A low-power rail-to-rail input/output operational amplifier specifically designed for portable applications is leveraged. The input common-mode voltage range extends beyond the supply rails for maximum dynamic range in low-voltage systems. The amplifier output has rail-to-rail performance with high-output-drive capability, solving one of the limitations of older rail-to-rail input/output operational amplifiers. This rail-to-rail dynamic range and high output drive make the amplifier ideal for buffering analog-to-digital converters. The operational amplifier has 6.4 MHz of bandwidth and 1.6 V/μs of slew rate with only 500 μA of supply current, providing good ac performance with low power consumption. Three members of the family offer a shutdown terminal, which places the amplifier in an ultralow supply current mode (IDD=0.3 μA/ch). While in shutdown, the operational-amplifier output is placed in a high-impedance state. DC applications are also well served with an input noise voltage of 11 nV/✓Hz and input offset voltage of 100 μV. 
     A mono bridged audio power amplifier capable of delivering power into a 3Ω load with less than 10% THD is also leveraged. To conserve power in applications, the LM4871&#39;s micropower shutdown mode (IQ=0.6 μA, typ) is activated when VDD is applied to the SHUTDOWN pin. It is specially designed to provide high power, high fidelity audio output. They require few external components and operate on the supply voltage of PCG_V3VA. 
     The communication between Healthy U App &amp; Healthy U device is achieved by Bluetooth BL-652-SA module. It is v5.0 single mode Bluetooth module. The supply voltage for Bluetooth module is BT_ECG 3V3D. The module specifications are provided in Table 19: 
     
       
         
           
               
             
               
                 TABLE 19 
               
               
                   
               
               
                 Bluetooth Module Specifications 
               
               
                   
               
             
            
               
                   
               
            
           
           
               
               
               
            
               
                 Wireless 
                 Bluetooth 
                 V 5.0 - Single-Mode 
               
               
                 Specification 
                 Frequency 
                 2.402-2.480 GHz 
               
               
                   
                 Transmit Power 
                 +4 dBm (maximum). −20 dBm(minimum) 
               
               
                   
                 Receive Sensitivity 
                 −96 dBm (typical) 
               
               
                 Host Interface 
                 UART Interface 
                 TX, RX, CTS, RTS 
               
               
                   
                   
                 From 1200 bps to 1 Mbps 
               
               
                   
                 I2C Interface 
                 1 I2C Interface (up to 400 kbps) 
               
               
                 Profiles 
                 Services Supported 
                 Laird&#39;s smart BASIC firmware supports the 
               
               
                   
                   
                 following: 
               
               
                   
                   
                 Central Mode 
               
               
                   
                   
                 Peripheral Mode 
               
               
                   
                   
                 Custom Series 
               
               
                   
                 Nordic SDK v3x0 
                 Any exposed within the related Nordic soft device 
               
               
                   
                   
                 (application development to be done by OEM) 
               
               
                 Programmability 
                 smart BASIC 
                 On-board programming language similar to BASIC. 
               
               
                   
                 smart BASIC application 
                 Via UART 
               
               
                   
                 download 
                 Via Over-the-Air (if SIO_02 pin is pulled high 
               
               
                   
                   
                 externally) 
               
               
                 Power 
                 Voltage 
                 1.8-3.6 V - Internal DCDC converter or LDO 
               
               
                   
                 Active Modes Peak 
                 Advertising mode 7.5 mA peak Tx (with DCDC) 
               
               
                   
                 Current (for maximum Tx 
                 Connecting mode 5.4 mA peak Tx (with DCDC) 
               
               
                   
                 power +4 dBm) - Radio 
               
               
                   
                 only 
               
               
                   
                 Active Modes Peak 
                 Advertising mode 2.7 mA peak Tx (with DCDC) 
               
               
                   
                 Current (for Tx Whisper 
                 Connecting mode 5.4 mA peak Tx (with DCDC) 
               
               
                   
                 mode2 power −40 dBm) - 
               
               
                   
                 Radio only 
               
               
                   
                 Active Modes Average 
                 Depends on many factors 
               
               
                   
                 Current 
               
               
                   
                 UltraLow Power Modes 
                 Standby Doze 2.0 uA typical 
               
               
                   
                   
                 Deep Sleep 400 nA 
               
               
                   
               
            
           
         
       
     
     Smart BASIC runtime engine firmware checks for the status of nAutoRUN during power-up or reset. The nAutoRUN pin detects if the BL652 module should power up into Interactive/Development Mode or Self-contained Run Mode. If nAutoRUN pin is at 0V and an “autorun” application exists in the modules file system, then firmware executes the smart BASIC application script automatically. The firmware may not execute the smart BASIC application script automatically. It allows developers to debug/change the script. nAutoRUN pin default state made HIGH by using 10K pullup resister connected to BT_ECG_3V3D. This pin is also connected with MICROCONTROLLER for making the nAutoRUN pin High/Low state using software. 
     Integrated chip antenna performance is sensitive to host PCB. It is critical to locate the antenna on the edge of the host PCB (or corner) to allow the antenna to radiate properly. Ensure there is no copper in the antenna keep-out area on any layers of the host PCB. Keep all mounting hardware and metal clear of the area to allow proper antenna radiation. For best antenna performance, place the module on the edge of the host PCB, preferably in the corner with the antenna facing the corner. 
     The charger is a cost-effective fully-integrated battery charger for Li-Polymer batteries. It uses current, voltage and temperature control loops to regulate the charge current. The high input voltage, up to 28V. A typical charge cycle includes trickle, constant-current (CC) and constant-voltage (CV) charge modes. The CC-mode current is programmable up to 600 mA with an external resistor. The voltage across the external resistor is also used to monitor the actual charge current. The constant voltage is fixed at 4.2V with 0.7% accuracy over a −20° C. to 70° C. temperature range. The trickle-mode current is preset to 20% of the CC-mode current when the battery voltage is lower than the trickle-mode threshold. The end-of-charge (EOC) current threshold is preset to 10% of the CC-mode current to save the board space and cost. A charge current thermal foldback feature limits the charge current when the IC internal temperature rises to a preset threshold. 
     The charger also protects the system with its input over-voltage protection (OVP) feature. In addition, the charger has a 2.6V falling power-on-reset (POR) threshold, making it perfect to work with current limited power supplies. Three indication pins (PPR, CHG and FAST) can be simply interfaced to a microcontroller. When no power supply is connected, or when disabled, the charger draws less than 1.0 μA leakage current from the battery. 
     The charger requires only two external capacitors and one resistor to build a fully functional charger for applications. Its ultrahigh-accuracy (±0.7%) output voltage and temperature-limited charging current offer additional battery safety during charging. The CC-mode current can be programmed with an external resistor (RISET). The voltage across this resistor is proportional to the charge current, so the system can monitor the charge current during the whole charge cycle. The EOC current threshold is preset to 10% of the CC-mode current. For a deeply discharged battery with a voltage lower than 2.7V, the charger charges the battery with a trickle-mode current, which is 20% of the CC-mode current. 
     A current shunt and power monitor with I2C interface is also leveraged. This module monitors both shunt voltage drop and bus supply voltage. Current sensor circuit is given in HealthyU schematic document, 0302-50012-000. 
     The Over voltage protection circuit (OVP) uses a P-channel MOSFET (SI2305CDS-T1-GE3) for load switching. It has a low RDS (on)=0.048 Ohm characteristics. 5.1V Zener diode (BZT585B5V1TQ-7) &amp; PNP transistor (MMBT3906LP-7B) is used for controlling the MOSFET gate. If the battery voltage is exceeding more than 5.1V, Zener breaks down &amp; this may turn OFF the transistor. A low at gate pin may switch off the MOSFET so there is no current flow between source to drain. 
     The power supply circuit is low-noise, linear regulators that deliver up to 500 mA of output current with only 10.5μVRMS of output noise from 10 Hz to 100 kHz. These regulators maintain ±1% output accuracy over a wide input voltage range, requiring only 100 mV of input-to-output headroom at full load. The 365 μA no-load supply current is independent of dropout voltage. The power supply circuit have nine, pin-selectable output voltages apart from nine we have selected the 3.3V for our application. It includes the programmable output soft-start rate, output overcurrent, and thermal overload protection. It is offered in an 8-pin TDFN package. The power supply circuit includes the following features: 1.7V to 5.5V Input Voltage Range; 0.6V to 5.3V Output Voltage Range; 10.5μVRMS Output Noise, 10 Hz to 100 kHz; 365 μA Operating Supply Current; 70 dB PSRR at 10 kHz; 500 mA Maximum Output Current; ±1% DC Accuracy Over Load, Line, and Temperature; 100 mV (Max) Dropout at 500 mA Load (3.6VIN); &lt;0.1 μA Shutdown Supply Current; Stable with 2 μF (Min) Output Capacitance; Programmable Soft-Start Rate; Overcurrent and Overtemperature Protection, and; Output-to-Input Reversed Current Protection. 
     Lastly, the unit construction materials are provided in Table 20: 
     
       
         
           
               
             
               
                 TABLE 20 
               
             
            
               
                   
               
               
                 Device Construction Materials 
               
            
           
           
               
               
               
            
               
                 S. No. 
                 Part Name 
                 Material Name 
               
               
                   
               
               
                 1 
                 Display side casing 
                 ABS: SD-0150 
               
               
                 2 
                 Protective display 
                 Poly carbonate 
               
               
                   
                 cover 
               
               
                 3 
                 Chest side casing 
                 ABS: SD-0150 
               
               
                 4 
                 On/Off button 
                 ABS: SD-0150 
               
               
                 5 
                 Finger electrode 
                 Brass IS 4413 plated with 
               
               
                   
                   
                 Nickel and GOLD plating 
               
               
                 6 
                 Chest electrode 
                 Brass IS 4413 plated with 
               
               
                   
                   
                 Nickel and GOLD plating 
               
               
                 7 
                 Diaphragm Sleeve 
                 PVC 
               
               
                 8 
                 Diaphragm 
                 Poly carbonate 
               
               
                   
               
            
           
         
       
     
     Backend Server 
     Now that the systems and methods for a personal medical monitoring device have been provided, attention shall now be focused upon apparatuses capable of executing the above functions in real-time. To facilitate this discussion,  FIGS. 16A and 16B  illustrate a Computer System  1600 , which is suitable for implementing embodiments of the present invention.  FIG. 16A  shows one possible physical form of the Computer System  1600 . Of course, the Computer System  1600  may have many physical forms ranging from a printed circuit board, an integrated circuit, and a small handheld device up to a huge super computer. Computer system  1600  may include a Monitor  1602 , a Display  1604 , a Housing  1606 , server blades including one or more storage Drives  1608 , a Keyboard  1610 , and a Mouse  1612 . Medium  1614  is a computer-readable medium used to transfer data to and from Computer System  1600 . 
       FIG. 30B  is an example of a block diagram for Computer System  1600 . Attached to System Bus  1620  are a wide variety of subsystems. Processor(s)  1622  (also referred to as central processing units, or CPUs) are coupled to storage devices, including Memory  1624 . Memory  1624  includes random access memory (RAM) and read-only memory (ROM). As is well known in the art, ROM acts to transfer data and instructions uni-directionally to the CPU and RAM is used typically to transfer data and instructions in a bi-directional manner. Both of these types of memories may include any suitable form of the computer-readable media described below. A Fixed Medium  1626  may also be coupled bi-directionally to the Processor  1622 ; it provides additional data storage capacity and may also include any of the computer-readable media described below. Fixed Medium  1626  may be used to store programs, data, and the like and is typically a secondary storage medium (such as a hard disk) that is slower than primary storage. It may be appreciated that the information retained within Fixed Medium  1626  may, in appropriate cases, be incorporated in standard fashion as virtual memory in Memory  1624 . Removable Medium  1614  may take the form of any of the computer-readable media described below. 
     Processor  1622  is also coupled to a variety of input/output devices, such as Display  1604 , Keyboard  1610 , Mouse  1612  and Speakers  1630 . In general, an input/output device may be any of: video displays, track balls, mice, keyboards, microphones, touch-sensitive displays, transducer card readers, magnetic or paper tape readers, tablets, styluses, voice or handwriting recognizers, biometrics readers, motion sensors, brain wave readers, or other computers. Processor  1622  optionally may be coupled to another computer or telecommunications network using Network Interface  1640 . With such a Network Interface  1640 , it is contemplated that the Processor  1622  might receive information from the network, or might output information to the network in the course of performing the above-described intelligent payroll management. Furthermore, method embodiments of the present invention may execute solely upon Processor  1622  or may execute over a network such as the Internet in conjunction with a remote CPU that shares a portion of the processing. 
     Software is typically stored in the non-volatile memory and/or the drive unit. Indeed, for large programs, it may not even be possible to store the entire program in the memory. Nevertheless, it should be understood that for software to run, if necessary, it is moved to a computer readable location appropriate for processing, and for illustrative purposes, that location is referred to as the memory in this disclosure. Even when software is moved to the memory for execution, the processor may typically make use of hardware registers to store values associated with the software, and local cache that, ideally, serves to speed up execution. As used herein, a software program is assumed to be stored at any known or convenient location (from non-volatile storage to hardware registers) when the software program is referred to as “implemented in a computer-readable medium.” A processor is considered to be “configured to execute a program” when at least one value associated with the program is stored in a register readable by the processor. 
     In operation, the Computer System  1600  can be controlled by operating system software that includes a file management system, such as a medium operating system. One example of operating system software with associated file management system software is the family of operating systems known as Windows® from Microsoft Corporation of Redmond, Wash., and their associated file management systems. Another example of operating system software with its associated file management system software is the Linux operating system and its associated file management system. The file management system is typically stored in the non-volatile memory and/or drive unit and causes the processor to execute the various acts required by the operating system to input and output data and to store data in the memory, including storing files on the non-volatile memory and/or drive unit. 
     Some portions of the detailed description may be presented in terms of algorithms and symbolic representations of operations on data bits within a computer memory. These algorithmic descriptions and representations are the means used by those skilled in the data processing arts to most effectively convey the substance of their work to others skilled in the art. An algorithm is, here and generally, conceived to be a self-consistent sequence of operations leading to a desired result. The operations are those requiring physical manipulations of physical quantities. Usually, though not necessarily, these quantities take the form of electrical or magnetic signals capable of being stored, transferred, combined, compared, and otherwise manipulated. It has proven convenient at times, principally for reasons of common usage, to refer to these signals as bits, values, elements, symbols, characters, terms, numbers, or the like. 
     The algorithms and displays presented herein are not inherently related to any particular computer or other apparatus. Various general purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct more specialized apparatus to perform the methods of some embodiments. The required structure for a variety of these systems may appear from the description below. In addition, the techniques are not described with reference to any particular programming language, and various embodiments may, thus, be implemented using a variety of programming languages. 
     In alternative embodiments, the machine operates as a standalone device or may be connected (e.g., networked) to other machines. In a networked deployment, the machine may operate in the capacity of a server or a client machine in a client-server network environment or as a peer machine in a peer-to-peer (or distributed) network environment. 
     The machine may be a server computer, a client computer, a personal computer (PC), a tablet PC, a laptop computer, a set-top box (STB), a personal digital assistant (PDA), a cellular telephone, an iPhone, a Blackberry, Glasses with a processor, Headphones with a processor, Virtual Reality devices, a processor, distributed processors working together, a telephone, a web appliance, a network router, switch or bridge, or any machine capable of executing a set of instructions (sequential or otherwise) that specify actions to be taken by that machine. 
     While the machine-readable medium or machine-readable storage medium is shown in an exemplary embodiment to be a single medium, the term “machine-readable medium” and “machine-readable storage medium” should be taken to include a single medium or multiple media (e.g., a centralized or distributed database, and/or associated caches and servers) that store the one or more sets of instructions. The term “machine-readable medium” and “machine-readable storage medium” shall also be taken to include any medium that is capable of storing, encoding or carrying a set of instructions for execution by the machine and that cause the machine to perform any one or more of the methodologies of the presently disclosed technique and innovation. 
     In general, the routines executed to implement the embodiments of the disclosure may be implemented as part of an operating system or a specific application, component, program, object, module or sequence of instructions referred to as “computer programs.” The computer programs typically comprise one or more instructions set at various times in various memory and storage devices in a computer (or distributed across computers), and when read and executed by one or more processing units or processors in a computer (or across computers), cause the computer(s) to perform operations to execute elements involving the various aspects of the disclosure. 
     Moreover, while embodiments have been described in the context of fully functioning computers and computer systems, those skilled in the art will appreciate that the various embodiments are capable of being distributed as a program product in a variety of forms, and that the disclosure applies equally regardless of the particular type of machine or computer-readable media used to actually effect the distribution 
     While this invention has been described in terms of several embodiments, there are alterations, modifications, permutations, and substitute equivalents, which fall within the scope of this invention. Although sub-section titles have been provided to aid in the description of the invention, these titles are merely illustrative and are not intended to limit the scope of the present invention. It should also be noted that there are many alternative ways of implementing the methods and apparatuses of the present invention. It is therefore intended that the following appended claims be interpreted as including all such alterations, modifications, permutations, and substitute equivalents as fall within the true spirit and scope of the present invention.