Products Description
Heading 5
Electronics and Control products
telmedx – MODELPROD – FORMYHEART
Product Description
It was the insight of Richard L. Anglin (telmedx CEO) to promote the integration of its telemedicine platform with the Integrated System of Process Control, MODELPROD,
created by Lorenzo Rossano.
Flagship product of the collaboration telmedx-Rossano is
Healthcare Interventional Decision Support (HIDS),
outlined below:
Technological level of products
Healthcare delivery is a complex market comprising multiple entities and actors with differing requirements and decision forcing functions. Some portions of the market are stove piped, that is, products and services are designed to address singular objectives of a limited set of entities and actors. Other portions of the healthcare market are multidimensional into which products and services address a spectrum of possible use cases, entities and actors. Product and service providers may elect to target singular or multifaceted markets.
The Healthcare Interventional Decision Support (HIDS) platform described is multidimensional and targets a wide spectrum of healthcare delivery use cases. HIDS platform configurations comprise multiple levels of technological complexity, address varieties of healthcare use cases, and price points. HIDS platform components may be marketed as stand-alone products, or integrated for broader capabilities.
The Healthcare Interventional Decision Support (HIDS) platform is shown above and its components described herein.
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Components and subsystems
1.1. telmedx Mobile-Phone Based Telemedicine Platform
telmedx provides a mobile phone-based platform that provides high-resolution live medical-grade video™ and high-resolution image capture from a mobile phone, tablet or other wireless device. The platform is encrypted and secure, and meets the patient security and privacy requirements of the European Union (EU) and the United States. The telmedx platform responds to medical requirements and easily integrates into established healthcare delivery workflows.
Live video sessions can easily be accessed via a Web browser on any personal computer, laptop or tablet connected to the Internet. Because the remotely located doctor, nurse or other caregiver uses a Web browser, there are no required capital expenditures or software maintenance. Furthermore, multiple doctors, nurses or other caregivers in multiple locations can access the same live video, and each has the ability to independently capture high-resolution images from that same video, thereby making consultations seamless.
The captured images are in the Web browser and may be saved by the doctor, nurse or other caregiver to an electronic medical record (EMR) or electronic health record (HER). If not saved and the Web browser is refreshed or closed, the captured images are erased from the Web browser.
A video of the telmedx platform may be found on the telmedx Website at www.telmedx.com/video. An additional video may be found on YouTube at www.youtube.com/watch?v=COkUPQhoxU0.
The telmedx core platform architecture is complete and has been deployed to customers and in usability trials. See Figure 1.1. A software application is downloaded into an Apple® iOS® or Android® device that enables a remotely located doctor, nurse or other caregiver to control the camera and other features of a mobile phone, tablet or other wireless device via a Web browser.
Figure 1.1. - The telmedx Telehealth/Telemedicine Platform
The telmedx platform operates on multiple networks, including 2.5G, 3G and 4G cellular networks; WiFi and WiMAX. It provides simultaneous live video and high-resolution image capture using the high-resolution camera in a mobile phone, tablet or other wireless device, the rear facing camera.
There is an inherent trade-off between resolution and frame rate. The remotely located doctor, nurse or other caregiver can in real time adjust the frame rate of the camera in a mobile phone, tablet or other wireless device, low frame rate for high-resolution assessment and higher frame rates for motion studies. The platform may also utilize the low-resolution facial recognition camera available on the face in many mobile phones, tablets or other wireless devices for video conferencing or video chat.
In a call center application the live video may seamlessly be added to the on-going audio call; the caller does not have to drop the audio call and call back in video mode as required by consumer-grade video conferencing systems. The telmedx platform is designed as a zero-install upgrade to existing audio call centers and remote medical offices, clinics and hospitals.
The telmedx platform is architected to transmit Bluetooth telemetry to add vital signs and other critical medical information to be displayed in the Web browser along with live video and captured images.
Traditional video conference or video chat systems deployed on wireless devices use Voice over Internet Protocol (VoIP), in which voice is digitized and transmitted through the data portion of a cellular network. The telmedx platform does not use VoIP, it employs a split architecture. The telmedx platform transmits voice via the voice portion of a cellular network and sends the video through the data portion of a cellular network. The net result of using a split architecture is the telmedx platform delivers 40-60 percent better voice quality than VoIP systems on wireless devices.
The telmedx application may be installed in any device that uses the Apple iOS or Android operating system such as the Google Glass and Google Gear.
1.2. Modelprod
Modelprod was conceptualized as a tool for management and control of productive activities. It has evolved as a mathematical model, mainly based on a schematic of the process "controlled system" whose functionalities are further represented by mathematical functions (transfer functions). Modelprod employs traditional methods of automatic control (with feedback or not). In other words, Modelprod enables management of processes as a black-box, with information elements as inputs that are manipulated according to identifying criteria for activities and process structure, producing outputs, generally seen as objective control. In the most general form, the control system is schematized by a matrix of transfer functions that represent the link between the input variables and outputs. The calculation of output values is accomplished applying systems theory via a calculation matrix, which is suitable for processing by computer.
The model is enriched by "expert systems" particularized by industry that are used for the collection of input data to the process (automatically by computer files) directly from the user's established information systems. In business applications such as accounting and production planning, these inputs are generally alphanumeric and are used as the basis for decisions and control of processes. Typically an analytic hierarchy process (AHP) is used to compare system choices on the basis of their attributes. AHP is a very powerful technique that may be effectively used for monitoring applications in healthcare. In addition to alphanumeric data, other input signals and images may be input. Clearly if the processes are schematic in mathematical systems, "simulation of process" can be run to demonstrate results. System responses are dependent upon input or structural variables.
1.2.1. Interface
The Modelprod interface (Formyheart) is a microprocessor-based system that enables integration of analytical data into the healthcare delivery process to enhance medical assessment, evaluation and care delivery. It can also be used as a personal mobile device, capable of monitoring and transmitting vital signals and parameters in real time to doctors and record data to PCs and Smartphones. Formyheart enables on-line exchange of data, signals (curves poly-graphic clinics) and alarms with healthcare providers anywhere in the world (by telephone and/or Internet) to enable faster assessment and better care direction.
1.2.2. CGS (General Control System)
Modelprod is a powerful system for managing information processes. Using AHP and “process simulation” it determines the analytical relation between influence parameters and system response. More precisely, based on matrix calculation, Modelprod includes a “no ending” model to simulate a process that determines the analytical relation between influence parameters and system behaviour, typically termed a “behaviour surface.” These characteristics make Modelprod particularly attractive for management and monitoring of patients in healthcare systems. For example, coupling images, data and signal inputs associated with cardiovascular assessments can be extended to other fields such as neurology that are physically more complex, but not from the mathematical point of view.
The general control system (CGS) comprises two sections of Modelprod, the management and control of information, the Patient Condition/Disease Management System and the decision processor, the Analytic Hierarchy Process. The first accepts input physiological signals from the sensors via the Formyheart, alphanumeric information about the patient, medical history for example, results of instrumental examinations (Radiology, Clinical Laboratory, etc.) and images and/or videos of the patient (using an Expert System, to obtain the maximum completeness and ease of management of incoming information). The second applies systems theory to threshold limits set by the doctor or other caregiver. The result is a comparison of the weighted results to determine a ranking of choices that provide an output to a diagnostic guide that prevents out-of-limits conditions
The application layer is most advanced in intensive care units: medical and surgical activities in areas of high specialization need a management system that ensures high quality interventions executed in minimal time. This integrated information system enables therapeutic procedures and monitoring, and receives data signals from multiple points of care in the hospital, including from the bed running as a local control and supervision at central level. The system allows the interrogation and piloting of instruments under master station supervision, realizing continuous adaptation of parameters of assistance based upon the patient's condition. In this way, the monitoring instrumentation and therapy provided at each bed (multi-parameter control units, ventilators, infusion pumps), is inserted into a cycle of continuous control (feedback loop) by a master control system resulting in optimization of response times and minimizing the possibility of error.
2. Technics
2.1. telmedx
The telmedx mobile phone-based telemedicine platform is typically used in one of two configurations:
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B2B (business-to-business): a collaborative consultation between caregivers
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B2C (business-to-consumer): patient to caregiver
2.1.1. B2B
Use of the telmedx telemedicine platform in a B2B configuration involves a collaborative consultation between caregivers.
For example, maxillofacial reconstructive surgeries are typically performed early in the morning. After surgery patients are left in the maxillofacial reconstructive surgery recovery room under the care of nurses; surgeons do rounds or attend to other patients. When things go bad after maxillofacial surgery, they go very bad very quickly. Rather than just describe conditions to surgeons verbally via phone, nurses in the maxillofacial recovery room use the telmedx platform to let the remotely located surgeon to see the patient’s condition. Use of the telmedx platform results in earlier condition assessment and care direction and yields better medical outcomes for patients.
A second example; integrated health systems typically employ home visitation nurses that visit patients at home or in long-term care facilities. When these circuit-riding nurses see a patient condition requiring intervention they collaboratively consult a senior nurse, Physician Assistant (PA) or doctor at the medical center to accelerate care direction and intervention. A primary objective is to obviate an Emergency Room (ER) visit.
A third example is wound follow-up care. For example, elderly people in assisted living or long-term care that undergo surgeries are sometimes hampered in follow-up care. They often have to travel to medical facilities for a three minute encounter with a nurse who undoes the wound bandage to observe the state of healing. Use of the telmedx telemedicine platform allows nurses, on their schedule, to remotely evaluate the state of wound healing. A caregiver or a family member can undo the wound bandage to allow the nurse to remotely evaluate the healing of the wound, perhaps foregoing the patient’s need to travel to a medical facility. The remote image capture feature of the telmedx platform allows the nurse to save captured images in the patient’s electronic health record (HER).
2.1.2. B2C
An out-of-clinic patient medical encounter typically begins with a voice call from a patient to doctor, nurse or healthcare provider. To assess the patient’s medical condition, the doctor, nurse or caregiver can ask the patient to start the telmedx application on their mobile phone, tablet or other wireless device, or the doctor, nurse or caregiver can remotely start the telmedx application. If the patient does not have the telmedx application on their wireless device, the doctor, nurse or caregiver can send an SMS containing a link that will download and install the telmedx application.
As the patient explains the medical issue, the doctor, nurse or other caregiver uses the telmedx platform as described infra.
2.2. Interface (Formyheart)
Documentation of the final design of the prototype, testing and test results are summarized here. The most complete version of the device is equipped with two input ports, one dedicated to ECG, and a common port that may be used for doppler, phono, wrist, blood pressure, glucose or other inputs and a single transmitting device. The following description refers to the ECG. The same considerations can be extended to additional ports, with associated signal analysis software.
Associated software is also comprised of several modules, independent and characterizing the various commercial versions of the device:
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device management (one for each version);
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signals management (one for each signal).
The functions of the transmitting device can be summarized in three blocks:
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acquisition, conditioning and amplification of the ECG signal
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A/D conversion
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modulation and wireless transmission
As shown in the figure below, the ECG signal (analog) is collected from the body surface using three electrodes placed at strategic points, before being transmitted to the device. The first block reduces the noise and the common mode signal, while amplifying and filtering the differential signal coming from electrical activity of the heart muscle. The second block performs the analog-digital conversion and acts as a controller of the third block. The third block performs modulation and wireless transmission to the receiver.
Fig. 2.1 – Functions of the transmitting device
2.2.1. Amplification and Conditioning
The analog circuit of ECG acquisition can be schematized in three blocks (Fig 2.1.1):
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1st stage: the differential amplification block comprises three instrumentation amplifiers INA122 with single power supply with offset managed by external and adjustable gain;
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2st stage: amplification stage (composed of six operational amplifiers LM358) which also performs filtering in the band of interest for the ECG which ranges from about 100Hz to 500MHz
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3st stage: circuit generating the reference voltage for the entire circuit and the electrode Ref.
Fig. 2.1.1. – Analog circuit of ECG acquisition
2.2.2. A/D Conversion
The second block, shown schematically in Fig 2.1 as analog/digital conversion, is a PIC16F876A microcontroller, from Microchip. Using a microcontroller rather than a simple A/D converter is necessary to control the wireless device. The microcontroller (µc) is used to manage the device as a slave transmitter to switch the data to be sent and to exercise control and setting.
2.2.3. Wireless USB Transmission
The transmission block uses an integrated circuit, CYWUSB6934, which is specifically designed to operate in the Industrial, Scientific and Medical (ISM) band frequency of 2.4 GHz. The CYWUSB6934 contains a Rice Lake transmitter, a Gaussian frequency shift keying (GFSK) modem and a dual direct sequence spread spectrum (DSSS) module. With 78 channels, spaced at 1 MHz, the DSSS module can generate 49 different spreading codes resulting in 3822 possible connections. An integrated amplifier manages the transmission power in a range of 30dB, while a synthesizer and a voltage controlled oscillator (VCO) determine the operating frequency of transmission and reception.
The DSSS module converts the data to be transmitted in a number of chips that depends on the mode of choice during the spreading device setting:
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64 chips/bit single channel – data rate 15.625 kbps
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32 chips/bit dual channel – data rate 31.25 kbps
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32 chips/bit single channel oversampling – data rate 31.25 kbps
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32 chips/bit single channel double data rate (DDR) – data rate 62.5 kbps
The choice of modes depends on the amount of data to be transmitted, the distance to be covered, and the interference environment. Another functional block in the device is the module serializer/deserializer (SERDES) that consists of a double buffer managed by the external microcontroller for data exchange. The serial-parallel interface (SPI interface) between the microcontroller and the wireless device enables the exchange of data to be transmitted and received. The SPI is effectuated by four connections between the CYWUSB6934 and PIC16F876A:
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Master Out - Slave In (MOSI)
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Master In - Slave Out (MISO)
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Serial Clock (SCK)
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Slave Select (SS)
Through the first two, the data exchange takes place, the third synchronizes the two devices and the fourth enables the SPI communication.
2.2.4. Updates
The discussion that follows refers specifically to the ECG, but the same considerations apply to the other input signals. Electrocardiography is one of the most important diagnostic methods to monitor proper heart function. It is widely used in clinical environments but more recently has been deplolyed in “home healthcare.” In home health, medical devices are intended to be used in the domestic environment and wirelessly communicate to a remote diagnostic center. A new project is based on a more powerful yet low power consumption microcontroller that is capable of measuring ECG and sending measured signals via a wired and/or a wireless network. In particular the ECG device communicated by acting as a slave USB port and, for the wireless network, as a Bluetooth node. In addition local storage is provided by integrating an SD card interface. The device may then communicate with a Smartphone, tablet or PC allowing use of their graphic capabilities to implement a complete monitoring system. The objective of the project is to design a unique core architecture that, by adding optional features, can accommodate different ECG application scenarios such as real time or holster-based monitoring in clinical, home environments, patient transportation and ambulance use, as well as in sports The device has a power supply subsystem; analog front-end subsystem; microcontroller subsystem; optional memory storage subsystem; and the above described wired and wireless interface subsystem.
Fig. 2.4.1 – New architecture of the device
To assure long battery life and easy interoperability with suitable hosts, for example, Smart phones and portable PCs, the wireless interface will preferentially be the Bluetooth Low Energy (BLE); this technology allows energy savings compared to classic Bluetooth. The BLE is fully supported by Android 4.3 devices (API level 18) and by the iOS devices from the iPhone 4S onward and is present in almost all the new generation notebook, subnotebook and ultrabook computers.
A further project objective is backward compatibility with older versions of the Bluetooth.
The microcontroller is used to coordinate the other subsystems and to process data from the leads. It embeds A/D conversion and powerful yet power efficient automatic logic unit (ALU) for fast data sampling and digital filtering to increase the native signal-to-noise ratio (S/N) of the input data. The monitor displays the data received from the ECG device and can save the data in memory or send it to another device. The reference architecture allows integration with other medical devices such as pulse oximeter, blood pressure, weight scale and the like. The minimum requirements are:
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3-channel derivations (up to 12 possible)
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Continuous ECG measurement with wireless data transmission (data rate up to 250Kbit/sec)
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Minimum Bandwidth: 125 Hz
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Selectable sampling rate per channel: 100 Hz, 250 Hz, 500 Hz
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Resolution: 16 bit Long in-use power (target use is 12 hours)
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Small overall footprint (targeted size: 6x8x3 cm)
2.2.5 telmedx – Formyheart interface Integration
The telmedx mobile phone-based telemedicine platform has been described in section 3.2.1 above. In terms of using the platform for input into the Healthcare Interventional Decision Support (HIDS) system, live video and remotely captured images are rendered into a Web browser on a Smartphone, tablet or personal computer.
For the live video to be input into the HIDS it must be captured from the Web browser by browser-enabled software. Examples are Screencast-O-Matic (www.screencast-o-matic.com) and WebVideoCap (webvideocap.software.informer.com) available for Windows; Kioskea (en.kioskea.net), a Firefox extension that runs both in Windows and Mac OS; and Freecorder 6 (webvideocap.software.informer.com), and extension for Chrome that also runs in Internet Explorer and Firefox. Transfer of the video once captured may be accomplished via Bluetooth, USB or SD.
Remotely captured images may be saved from the Web browser into an appropriate file system for input to the HIDS.
3.3. Operation of the Healthcare Interventional Decision Support System
The scientific literature on control techniques based on mathematical models groups variables that characterise the system function into three categories, dependent respectively:
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decisions the model has to assume;
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performances the model has to give;
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configuration the model has to have.
The first variable is driven by the process to be controlled and includes system capacity, project objectives, and optimization of resources. The second variables reflect indices of performance provided by the system such as efficiency and stress functions. The third variables relate to the structure and behaviour of the system, such as structural and output variables.
The HIDS starts in a control model that configures an evaluation and calculation process to analyse, support, verify, and tune variables through application of objective methodologies (mathematical) that are completed and enriched through operational experience and knowledge.
3.3.1. GCS - Patient Condition/Disease Management System
To manage a process it is necessary to apply the mathematical fundamentals of system control, to define them, their properties, their limits, their interfaces with the external, their nature, their control points. Further, it is necessary to measure the parameters, to make suitable corrections to address issues and problems. This section focuses on process simulation contained in Modelprod. Input data storage functions in a relational database are used to calculate variables (information) output, or to send to the next system process.
3.3.2. GCS - Decision Analytic System
The term “decision model” means the set of calculation functions applied to process control. A weighted method AHP is the starting point for the decision model. Through a matrix calculation to solve systems of linear homogeneous equations, it is possible to classify choices with an overall score, thus obtaining a decisional comparison diagram comprising both intuitive and objective parameters. Matrix calculation in support of AHP is based on the following procedure: the first step is to identify the factors of relevance for the decision to be made. These factors comprise the vector |pj| with j=1…..m, where m stands for possible decision alternatives. In the model m=10. In the second step criteria weights are calculated and alternative choices are classified. Reference is made to literature on this subject that the human brain has difficulty in selecting merit figures exceeding 5. The merit scale proposed by Saaty is used:
The alternative choices are collected into the |Pi| vector with i=1……..n. It is fixed n=5. The third step is to assign partial merit figures. These may be collected into comparison matrices that have been defined into one primary target comparison matrix A and ten secondary target comparison matrix FDm. The fourth step is the calculation of the results; that is, the determination of the vector of the alternative global weighted merit figures. The calculation criterion consists in solving the following equality matrix according to the auto-value method:
A * |P| = K * |p|
with:
A = evaluation matrix
P = decision factors vector
K = major auto-values
where: k is the major of auto-values of matrix A and Km, with m = 1……10, the major of auto-values of matrix SDm. As such equalities are systems of homogeneous linear equations and the matrices have a unitary rank, non-banal solutions exist, are unique and consist of positive values.
Particularly:
Let us assume that a comparison is made using AHP method on items on the basis of their weight. Identify with n the number S1 … Sn, with a known weight respectively equal to W1 … Wn. Building a matrix placing in the rows the relations among the weights of each item and the total weight of all the others. The following matrix equality is always verified:
where A is the comparison matrix and |W| the weight vector.
To determine the absolute weight of the items, the comparison matrix known, the matrix equation must be solved:
A * |W| = n * |W|
It is a system of linear homogeneous equations that do not have banal solutions only if n is an auto-value of the matrix A. Note that since every row of matrix A is a multiple of the first row, this matrix has a unitary rank; therefore all but one auto-values are null. On the other hand the sum of the auto-values of a matrix is equal to the sum of the values on the principal diagonal and thus, in this case, is again equal to n. From this n is an auto-value of the matrix A: the non-banal solution exists, is unique, apart from multiplying constants and consists of positive values. Generally speaking the consistence of the evaluations improves if there the subsequent conditions exist:
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the items in a group are homogeneous, because it is difficult to compare too different items;
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the number of items in a group is limited, because it is difficult to manage relations among too many items; and
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the decider has deep knowledge and is fully involved with the problem under consideration.n
