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- 1. MCT Mode: Use on adult patients who experience transient or non-transient symptoms that may suggest cardiac arrhythmia The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia occurs. - 2. Holter Mode: Use on adult patients experiencing palpitations, syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG. - 3. Multi-Lead (Resting EKG) Mode: Use on adult patients for acquiring, storing and viewing/printing of up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the patient's body.

The ACS Cardiac Outpatient Real Time ECG (CORE™) monitor is a multipurpose device designed with the ability to perform: a 2-lead (2 or 3-electrode) Mobile Cardiac Outpatient Telemetry complete with Arrhythmia Detection and Alarm for up to 30 days; a 24-hour or longer 3-lead (5electrode) or a resting 12-lead (10-electrode) EKG. The ambulatory device may be used on an outpatient basis with remote clinician data analysis as well as use within the physician office setting by a medical professional. The CORE™ monitor is comprised of 1) a single component ECG monitor with an integrated cellular modem and 2) an interface to four independent cable configurations through a single connector. The CORE™ device automatically changes functionality when a specific cable with the same form factor is inserted with the following configurations: 3-wire, ambulatory, snap electrode cable invokes a 1, or 2-lead MCT mode (Lead I, II - no anterior views). 5-wire, ambulatory, snap electrode cable invokes the Holter 3-lead mode by default (up to 5-leads are available with anterior views). 10-wire, resting (lengthened for full body), alligator clip electrode cable invokes the Resting 12-lead EKG mode (8-channels; derived Leads III, aVF, aVR, aVL). A USB cable invokes the PC communication service mode. Cable is interchangeable with ECG lead sets requiring disconnection from the body before connection to an external device can be made. The built-in cellular modem technology pushes and pulls information to and from the device in a HIPAA compliant fashion using the cryptographic protocol; Transport Layer Security (TLS). Additional data integrity is performed by Error Correction Coding (ECC) and MD5 hash sums. The CORE™ device houses a microprocessor for running the algorithm and an Application Specific Integrated Circuit (ASIC) for controlling the CORE™ device, a rechargeable battery, real time ECG Arrhythmia Detection using built-in hardware DSP engine in any mode, ECG capture circuitry provided by the ASIC and the multiple components, GSM/GPRS/EGPRS/WCDMA/HSPA network transceivers for cellular communication, Cellular SIM card, high-capacity SD flash card (up to 1024 GB), internal EEPROM, GPS module, a Bluetooth transceiver and a Zigbee (IEEE 802.15.4) transceiver for bi-directional communication with external devices, a full-color LCD touch screen display, 5-button keyboard, Power and Event button, 3-axis accelerometer, RGB color LED indication module, speaker/microphone, external battery charger, and a USB device port. The CORE™ device utilizes an embedded algorithm developed by Applied Cardiac Systems, Inc. to analyze ECG signals in real-time. Upon detection of an arrhythmic or patient-activated event, the ECG signal is transmitted wirelessly via the cellular network to a remote Monitoring Center for additional analysis and intervention by a clinician. When cellular service is unavailable, the event will be stored until such time the cellular network becomes available or the patient transmits the data using a land telephone line. When in the resting 12-lead EKG mode, the device can capture and display 12 channels of ECG. The ECG can be streamed in real-time to a PC wirelessly via the 802.15.4 network transceiver to be displayed, printed, and stored. An embedded SQL database is used in the device for ECG storage and reporting in all modes - MCT, Holter, and resting 12-lead.

Current indications for use of the ACS™ Model NCP-2 are: . Stable Angina Pectoris . Unstable Angina Pectoris Acute Myocardial Infarction . Cardiogenic Shock . Congestive Heart Failure

The ACS Model NCP-2 External Counterpulsation Device (ECP) is comprised of three major components, a Control Console, a Treatment Bed, and a set of patient Cuffs. The device is a microprocessor-controlled system that inflates and deflates three pairs of air cuffs, which compress vascular beds in the muscles of the calves, thighs, and buttocks to achieve the desired therary. The Control Console is comprised of a signal amplifier module, a power module, a microprocessor control module, a keyboard control panel with trackball, a Liquid Crystal Display (LCD) panel, and a Personal Computer (PC) with storage drives, data entry QERTY keyboard, network card, and printer. Control console input and data from the ECG, finger plethysmograph, and the pressure/vacuum transducers are processed by the microprocessor to control the valve timing and pressure delivered to the cuffs. Treatment pressure is monitored with an internal pressure sensor and the operator-selected set point maintained by a closed-loop control system. Valve inflation and deflation timing is also set by the operator based on the relative position of the R-wave of the patients ECG. The PC is used to enter patient demographics, record pre and post-treatment data, and process data acquired by the microprocessor module to display user feedback for the ECP treatment on the LCD showing treatment parameters and patient waveforms during use. An internal hard disk drive is used to store data on the system, a CD/DVD drive is used to record data onto removable media, and a printer is used to produce hard copy of a report that includes all of the pertinent treatment data for individual treatments and a session summary of all treatment data collected for 35 or more days. The Treatment Bed accommodates the air compressor, a pressure and vacuum reservoir, inflation and deflation valves and a motorized lifting mechanism for the mattress assembly. The motorized lifting mechanism is used to move the mattress up and down, providing a convenient height for patient and operator use. The valve assembly consists of three pairs of inflation and deflation valves that open and close on command to inflate or deflate the patient Cuffs with air. The valve manifold assembly is connected to the air compressor and pressure/vacuum reservoir components via connecting air hoses. External pressure is delivered to the lower extremities of the patient in synchronization with the heart, i.e. the cuffs compress vascular beds in the calves, lower thighs and upper thighs/buttocks on inflation. When the heart is in its relaxed state during the diastolic period, pressure is applied sequentially from the calves, to the lower thighs, to the upper thighs and buttocks, forcing blood back to the heart, increasing coronary perfusion pressure and coronary blood flow (diastolic augmentation), as well as venous return, Immediately before the heart begins to eject blood during the next systolic phase, the Cuffs are rapidly deflated and all externally applied pressure is eliminated. The vasculature in the lower extremities re-conforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased after-load). Stretchable treatment pants comprised of cotton and Lycra (Spandex) are worn by the patient under the Patient Cuff Set to allow for greater comfort during treatment.