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The TeleRehab® Aermos Cardiopulmonary Rehabilitation System is intended to acquire and condition the ECG signal from a patient so that it can be transmitted wirelessly from a radiofrequency transmitter to a workstation in a hospital or a clinical setting where the data is displayed and analyzed. This device also measures heart rate and provides visual and audible alarms if the patient's heart rate goes out of a prescribed range. This device is for use with ambulatory adult patients who need monitoring while undergoing cardiovascular and/or pulmonary rehabilitation. The physiological data from monitoring and other patient information (such as patient demographics, exercise protocol and medical information) is stored in a database for tracking and reporting of the patients' progress through rehabilitation.

The TeleRehab® Aermos Cardiopulmonary Rehabilitation System ("Aermos") provides the ECG monitoring functionality required for performing rehabilitation of cardiovascular and/or pulmonary patients. Patients' ECG may be monitored using the Aermos system during exercise under clinical supervision. During monitoring, Aermos provides both visual and audible alarms if the patient's heart rate goes out of a prescribed range. The heart rate alarm indication is one of multiple inputs a clinician may use to modify and adjust rehabilitation activities such as decreasing the patient's level of physical exertion or halting the exercise entirely. Aermos also provides the ability to plan a patient's rehabilitation program and document the patient's progress through the creation of various types of reports. The report types supported in Aermos include individual treatment plan reports, daily exercise session reports and various patient information reports. Additionally, the Aermos system provides the ability to transfer various report types to the hospital Electronic Medical Records system. The main components of Aermos are Argus ECG transmitters, the Aermos Workstation and associated networking equipment.

The TeleSense device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia. The device continuously monitors and records the data, automatically records events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician. The TeleSense is a battery powered device to be used to measure, record, store and/or remotely transfer the Electrocardiogram (ECG) noninvasively in mobile patients. The available data transfer methods are USB and Wi-Fi. TeleSense is not limited to certain patient groups or pathologies; however, the TeleSense is not intended for pediatric use. Examples of applications are: - Cardiology - Pulmonary Care - Home Care - General Practitioners

The basic operation of the TeleSense platform is to collect and store multiple channels of ECG data. The TeleSense platform was developed to be used as basic platform for 4 different variants on the product, hereafter called "modes". The electronic platform of the different versions is identical but the different modes have some features added or removed from the electronic platform. The differences are related to features. All versions have the same intended use, intended users and intended environment. The different versions are described below. 1. Basic Mode (Remote cardiac monitor) TeleSense's Basic Mode is the basic version of the product. It is a battery powered portable device to be used to collect, record, store and/or remotely transfer the Electrocardiogram (ECG) in mobile patients, as well as cardiac event data. The device only uses non-invasive sensors. The available integrated data transfer methods are USB and Wi-Fi. 2. Event Mode TeleSense's Event Mode operates as a traditional event recorder. It is a battery powered portable device to be used to collect, record, store and/or remotely transfer manually indicated or automatically detected cardiac events in mobile patients. The device only uses non-invasive sensors. The available integrated data transfer methods are Wi-Fi and USB. 3. Holter Mode TeleSense's Holter Mode operates as a traditional Holter recorder. It is a battery powered portable device to be used to collect, record, store and/or remotely transfer the electrocardiogram (ECG) in mobile patients. The device only uses non-invasive sensors. The available integrated data transfer methods are Wi-Fi and USB. In this version, there is no automatic cardiac event detection.

The TeleSentry device is intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest non-lethal cardiac arrhythmia. The device continuously monitors and records the data, automatically records alarm events triggered by an arrhythmia detection algorithm or manually by the patient, and automatically transmits the recorded event activity associated with these symptoms for review by a licensed physician.

TeleSentry is a battery powered ambulatory ECG monitor which analyzes an electrocardiographic signal. The TeleSentry device classifies all detected heart beats and recognizes specific rhythm abnormalities. All detected results, including annotations for every detected heart beat and the ECG signals are securely transmitted via a cellular telephony network to a remote server. The server is accessible by a monitoring center for review and evaluation by trained qualified medical staff. The data transmission is automatically triggered when abnormalities are detected. The triggering criteria are based on physician's recommended predetermined settings and adjustable thresholds programmed for brady, tachy, pause and afib events. The data will also be transmitted when manually triggered by the patient; or periodically if programmed for regular transmission. The TeleSentry device is equipped with sufficient memory and processing capacity to record the signal received from the sensor, even while in parallel, allowing interrogation of the device data or adjustment of triggering thresholds. The TeleSentry device records and stores the entire ECG full disclosure for up to 30 days on its internal storage card. When cellular service is not available, the monitoring center is immediately notified and data can be transmitted via land-line telephone using a USB connection or a Bluetooth connection, or via broadband internet connection.

The intended use of the Chroma Holter Recorder RZ153C is to perform ambulatory ECG on the order of a physician, on those patients who may benefit from such a recording, including, but not limited to, those with complaints of palpitations, syncope, chest pain, shortness of breath, or those that need to be monitored to judge their current cardiac functionality such as patients who have recently received pacemakers. The data obtained at recording is not analyzed at the time of the recording.

The basic operation of the Chroma Holter Recorder RZ153C is to collect and store multiple channels of ECG data. The Holter scanner software reads this data and it can be printed out in tabular form or graphical form. This recorder is not capable of any diagnosis nor can it provide any interpretation of the data. It can only display and store the data. The Holter for Windows software reads this data and provides ability to the user to review, edit and print the data collected.

The intended use of the ScottCare Genesis ECP device is to provide external counterpulsation (ECP) therapy, and is indicated for use in the treatment of stable or unstable angina pectoris, congestive heart failure, cardiogenic shock, and acute myocardial infarction.

The "Genesis" is a non-invasive medical device for performing external, sequential counterpulsation. It 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 therapy. The microprocessor's primary function is to serve as an R-wave detector, calculate the R-wave rate (heart rate), and deliver triggering signals to actuate valves that allow the cuffs to be filled during the diastolic period and then emptied prior to systole. The secondary function of the microprocessor is to output, through a serial port, information necessary for displaying patient treatment data on a video monitor. This data allows a trained operator to finetune the inflation/deflation signals to optimize a patient's diastolic augmentation. The cuffs are snugly wrapped around the patient's calves, thighs, and buttocks to allow compression of vascular beds in these body areas. To prevent skin irritation the patient is typically dressed in tight fitting, stretchable treatment pants prior to being fitted with the cuffs. As diastole begins, the cuffs inflate sequentially proceeding from the calves, to the thighs, to the buttocks, with the inflation sequence taking a total of approximately 200ms. The inflation sequence generates and drives an arterial counter pulsation wave creating an increase in coronary perfusion pressure and coronary blood flow. The compression sequence also increases venous return, which increases stroke volume and cardiac output. At the end of diastole, and just before the next QRS complex, the cuffs are evacuated simultaneously over a period of approximately 120ms. The course of treatment is typically 35 1-hour treatments administered 5 days a week. The device automatically stops compression of the cuffs and releases all pressure in the cuffs upon completion of the pre-set treatment timer. The system consists of two major assemblies: 1) the patient bed that houses the electronic pneumatic controls / valves, compressor / vacuum pump and associated power supplies and 2) the operator's console that consists of an all-in-one computer/monitor, computer peripherals (keyboard and pointing device) and a control panel.

This device is intended to acquire and condition the ECG signal from a patient so that it can be transmitted via radio frequency to a workstation in a hospital or clinical setting where the ECG is displayed and analyzed. This device is for use with ambulatory adult patients, which need monitoring while undergoing cardiac or pulmonary rehabilitation, or other monitoring. The data output from the telemetry remains of the patients' progress through rehabilitation or other monitoring. Patients demographies, exercise protocor hire wireless input devices or automatically a variety of connifereially available weeks. A database can be created for use with an Outcomes program.

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