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The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The NUVANT System monitors, derives and displays: - ECG - Heart Rate

The NUVANT MCT System consists primarily of the PiX monitoring device and the zLink data transmission device. Once activated, the wearable PiX sensor continuously monitors the heart and automatically collects ECGs. When rhythm abnormalities are detected, data are automatically transmitted from the PiiX device to the zLink, which then automatically transmits the data to the Corventis Monitoring Center. Patients can also trigger transmission of ECGs when they experience cardiac symptoms by using the Patient Trigger Button. Certified cardiographic technicians at the Corventis Monitoring Center review received data and document symptoms reported by patients. Clinical reports, prepared by the Corventis Monitoring Center, are delivered and made available at www.corventis.com to provide data to prescribing physicians for the diagnosis and identification of various clinical conditions, events and/or trends.

The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The NUVANT system model monitors, derives and displays: • ECG · Heart Rate

The NUVANT MCT System is a wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), NUVANT MCT enables arrhythmia detection for up to 7.5 days for each PiiX application. The NUVANT system components are: - PiiX® (aka: Adherent Device) a patient-worn device which is applied to the . patient's torso. It contains the ECG electrodes for recording ECG and heart rate data. - Patient Trigger Magnet used by the patient to manually trigger the ECG . collection when he/she experiences symptoms. - . zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology. - Server The Server receives sensor data from the PiiX via zLink. ECG and . heart rate are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink.

The AVIVO Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for patients: - with fluid management problems . - taking diuretic medication . - living with heart failure . - living with end-stage renal disease . - suffering from recurrent dehydration . - who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but . not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The AVIVO Mobile Patient Management System also monitors, derives and displays: - ECG . - Heart Rate (including HR variability) . - . Activity - . Posture - Respiration rate (including RR variability) - Body fluid status

The AVIVO System is wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias and monitor physiologic signals. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), AVIVO enables arrhythmia detection and other physiological data monitoring for up to 7 days for each PiiX application. The AVIVO system components are: - . PiiX® (aka: Adherent Device) - a patient-worn device which is applied to the patient's torso. It contains the ECG electrodes for recording ECG, heart rate and other physiological data. - . zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology. - Server The Server receives sensor data from the PiiX via zLink. ECG, heart . rate and other physiological parameters are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink.

The NUVANT Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to, supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders.

The NUVANT MCT System is wearable, wireless arrhythmia detection system that is used by clinicians to identify suspected cardiac arrhythmias. In combination with interpretation services provided by learned intermediaries in the Corventis Monitoring Center as well as online review of data (for prescribing physicians only), NUVANT MCT enables arrhythmia detection for up to 7.5 days for each PiiX application. The NUVANT system components are: - PiiX® (aka: Adherent Device) - a patient-worn device which is applied to the patient's torso. It contains the ECG electrodes for recording ECG and heart rate data. - Patient Trigger Magnet used by the patient to manually trigger the ECG collection when he/she experiences symptoms. - zLink® (aka: Gateway) – hand-held device that receives information from the PiiX and transmits it to the Corventis Server via cellular technology. - Server - The Server receives sensor data from the PiiX via zLink. ECG and heart rate are presented to learned intermediaries, Corventis cardiographic technicians, who prepare and deliver the information to prescribing physicians The communication between the PiiX and the zLink is enabled via BlueTooth Technology. Sensor data and ECGs collected by the PiiX are transmitted to the Server via zLink.

The AVIVO™ Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO Mobile Patient Management System also monitors, derives and displays: - ECG - Heart Rate (including HR variability) - Activity - Posture - Body Temperature - Respiration rate (including RR variability) - Body fluid status The NUVANT™ Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The NUVANT system model monitors, derives and displays: - ECG - Heart rate The Systems may also monitor, derive and display: - Activity - Posture - Body temperature - Respiration rate (including RR Variability) - Body fluid status - Heart rate variability

The NUVANT is essentially the AVIVO with the addition of a patient trigger magnet. The following are the system components of both models: - PiiX™ (aka Adherent Device) - Patient Trigger Magnet (specific to NUVANT) - zLink™ (aka Gateway) - Server The PiiX is a patient-worn device which is applied to the patient's torso. It contains the ECG electrodes for recording ECG and heart rate data; the impedance sensor for collecting respiration and body fluid data; the accelerometer for collecting activity and posture. Additionally, resided in the PiiX is a heart rate, timing and morphology based arrthythmia detection algorithm which allows the system to discriminate waveforms based on morphology and also count ectopic beats (such as PVCs and PACs) and calculate atrial fibrillation burden of the patient. Specfic to the NUVANT is the Magnet, which is part of the Patient Trieger feature. This external piece accompanying the PiiX and is used by the patient to manually trigger the ECG collection when he/she experiences symptoms. Patient triggers the ECG collection by swiping the Magnet across the PiiX. The ECG waveform will then be transmitted to the Server via zLink. zLink receives information from the PiiX and transmits them to the Corventis Server. It also interacts with the Corventis Server to receive configuration updates and other relevant hardware diagnostic information. The Server receives sensor data from the PiiX via zLink. Data from the accelerometer is derived into activity and posture; data from the impedance sensor is derived into respiration rate, respiration variability and body fluid status. ECG and heart rate are presented without derivation. Additionally, the secure server performs the following functions: - Display the physiological parameters in trend graphs format. - Display ECG waveform that corresponds to a detected arrhythmia - Provide patient's Afib burden, if applicable - Provide visual notifications for the detected arrhythmia. - Provide the users the ability to acknowledge or dismiss events. The communication between the PiiX and the zLink is enabled via the BlueTooth™ Technology. The zLink transmits the data to the Server via cellular technology, where healthcare professionals can access with standard browsers.

The NUVANT" Cardiac Event Monitor (CEM) System and the NUVANT "Mobile Cardiac Telemetry (MCT) System are intended to continuously measure, record, and periodically transmit physiological data. The Systems are indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. Both NUVANT system models monitor, derive and display: - ECG - Heart rate The Systems may also monitor, derive and display: - Activity - Posture - Respiration rate (including RR Variability) - Body fluid status - Heart rate variability

The NUVANT™ Cardiac Event Monitor System and the NUVANT™ Mobile Cardiac Telemetry System include the following components: - PiiX™ (a patient worn adherent device) with Magnet - zLink - Server The PiiX is a patient-worn device which is applied to the patient's torso. The Adherent Device monitors the patient's ECG in a looping mode. There are three circumstances under which the ECG data will be recorded: (i) when the device is first applied and activated, a baseline ECG is collected, (ii) when the detection algorithms residing in the Adherent Device trigger the collection, or (iii) when the patient activates the collection using the magnet. When the ECG collection is triggered, a total of 45 seconds of ECG signals will be collected, with 15 seconds of pre-event and 30 seconds post-event. Same as the AVIVO™ Mobile Patient Management System (predicate device), the PiiX has additional sensors which monitor other physiological parameters described in the Indications for Use Statement. The collected ECG signals and the other sensor data will be transmitted to the Server via the zLink. The zLink receives information from the PiiX and transmits them to the Corventis Server. It also interacts with the Corventis Server to receive configuration updates and other relevant hardware diagnostic information. The Server of the CEM/MCT receives information from the PiiX via zLink. The secure server performs the following functions: - Derive physiological parameters using the raw data collected by the Adherent Device. - Display the physiological parameters in trend graphs format. - Display ECG waveform when the heart rates are beyond the specified threshold. - Provide visual notifications when healthcare professionals need to be aware of heart rates that are beyond the specified threshold. - Provide the users the ability to select CEM vs. MCT prescription. - Provide the users the ability to acknowledge or dismiss events. The communication between the PiiX and the zLink is enabled via the BlueTooth™ Technology. The zLink transmits the data to the Server via cellular technology, where healthcare professionals can access with standard browsers.

The AVIVO™ Mobile Patient Management System is intended to continuously record, store, and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias. The AVIVO™ Mobile Patient Management System also monitors, derives and displays: • ECG - · Heart Rate (including Heart Rate Variability) - · Activity - Posture - · Body Temperature - · Respiration rate (including Respiratory Rate Variability) - Body fluid status

The AVIVIO Mobile Patient Management System includes the following components: - Adherent Device . - Gateway . - Server . The Adherent Device is a patient-worn device. It collects, stores and transmits user physiological parameters. The Adherent Device, when applied to the user's torso, will automatically activate and measure the above mentioned physiological parameters. Data collected by the sensors are transmitted to the Server for derivation and display via the Gateway periodically. ECG signals recorded by the Adherent Device will be transmitted on a heart rate trigger basis with predetermined thresholds that are not user adjustable. The ECG signals are also transmitted periodically and will be displayed via the Server. The Gateway receives information from the Adherent Device and transmits them to the Corventis Server. It also interacts with the Corventis Server to receive configuration updates and other relevant hardware diagnostic information. The Server receives information from the Adherent Device via the Gateway. The secure server performs the following functions: - Derive physiological parameters using the raw data collected by the Adherent . Device. - Display the physiological parameters in trend graphs format. . - Display ECG waveform when the heart rates are beyond the specified threshold. t - Provide visual notifications when healthcare professionals need to be aware of . heart rates that are beyond the specified threshold. - Provide patient summary reports. . The communication between the Adherent Device and the Gateway is enabled via the BlueTooth™ Technology. The Gateway transmits the data to the Server via cellular technology, where healthcare professionals can access with standard browsers.