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The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for: - 1. Patients who have a demonstrated need for cardiac Monitoring. These may include but are not limited to patients who require Monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic fung disease. - 2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded: c) dyspnea (shortness of breath). - 3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. - 4. Patients who require outpatient monitoring of antiarrhythmic therapy: a) Monitoring of therapeutic and potential proarrhythmic effects of membrane active drugs, b) Monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). - 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia Monitoring. - 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias - 7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter. - 8. Patients requiring measurement, analysis and reporting of QT interval, excluding patients with a documented history of sustained atrial fibrillation or atrial flutter - 9. Patients who require monitoring for potential arrhythmias based on risk factors (e.g. atrial fibrillation). - 10. Patients requiring measurement of ST segment changes. The device is not intended to sound any alarms for ST segment changes.

The CardioNet ECG Monitor with Arrhythmia Detection CN1006 is an ambulatory ECG monitor with capability to detect cardiac arrhythmias and transmit ECG data to a CardioNet staffed monitoring center. The subject device is comprised of three (3) main components: 1) a patient-worn Sensor, 2) a Monitor and 3) a charging Base. A Sensor acquires the ECG signal from the patient's body and transmits the signal to PDA sized monitor where the data is stored and analyzed by an automated arrhythmia analysis algorithm residing in the Monitor. When events are detected by the analysis algorithm or when indicated by the patient pressing the event key on the Monitor, the Monitor will transmit the data to the Monitoring Center. Data can be uploaded to the Monitoring Center in a variety of ways -Transmitted via Cellular RF modem or via RF to the Base for transmission via the patient's landline telephone. The data is received and reviewed by trained technicians using the Monitoring Services Application.

The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for: - Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease. - Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b). syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath). - Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. - Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). - Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring. - Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias - Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter - Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes

The CardioNet ECG Monitor with Arrhythmia Detection Model CN1005 is an ambulatory ECG monitor with capability to detect cardiac arrhythmias and transmit ECG data to a CardioNet staffed monitoring center. The subject device is comprised of three (3) main components: 1) a patient-worn Sensor, 2) a Monitor and 3) a charging Base. A Sensor acquires the ECG signal from the patient's body and transmits the signal to PDA sized monitor where the data is stored and analyzed by an automated arrhythmia analysis algorithm residing in the Monitor. When events are detected by the analysis algorithm or when indicated by the patient pressing the event key on the Monitor, the Monitor will transmit the data to the Monitoring Center. Data can be uploaded to the Monitoring Center in a variety of ways - Transmitted via Cellular RF modem or via RF to the Base for transmission via the patient's landline telephone. The data is received and reviewed by trained technicians using the Monitoring Services Application.

The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for: 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease 2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath). 3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. 4. Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring. 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias 7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter 8. Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes

The CardioNet ECG Monitor with Arrhythmia Detection Model CN1004 is an ambulatory ECG monitor with capability to detect cardiac arrhythmias and transmit ECG data to a CardioNet staffed monitoring center. The subject device is comprised of three (3) main components: 1) a patient-worn Sensor, 2) a Monitor (communications Gateway) and 3) a charning Base. A Sensor acquires two (2) channels of ECG data from the patient's body. This ECG in the Sames Will in the Sensor. When events are detected by the analysis algorithm or when indicated by the patient pressing the event key on the Monitor, the Sensor will upload the data to the Monitor. The ECG data is then uploaded to the Monitoring Center. Data can be uploaded to the Monitoring Center in a variety of ways - Transmitted via Cellular RF modem or via RF to the Base for transmission via the patient's landline telephone. The data is received and reviewed by trained technicians using the Monitoring Services Application.

The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for: 1. Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease 2. Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath). 3. Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. 4. Patients who require outpatient monitoring of antiarrhythmic therapy: a) monitoring of therapeutic and potential proarrhythmic effects (e.g. QT prolongation) of membrane active drugs b) monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). 5. Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring. 6. Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias 7. Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter 8. Patients requiring measurement, analysis and reporting of the QT interval, excluding patients with a documented history of sustained atrial fibrillation or atrial flutter.

The CardioNet ECG Monitor with Arrhythmia Detection is an ambulatory ECG monitor with capability to detect cardiac arrhythmias and transmit ECG data to a CardioNet staffed monitoring center. The subject device is comprised of three (3) main components: 1) a patient-worn Sensor, 2) a Monitor and 3) a charging Base. A Sensor acquires the ECG signal from the patient's body and transmits the signal to PDA sized monitor where the data is stored and analyzed by an automated arrhythmia analysis algorithm. When an arrhythmic event is detected the monitor can transmit the ECG data to the monitoring center utilizing a cellular modem or telephone data line. The patient can also initiate the recording and transmission of ECG data if symptoms are felt. The data is received and reviewed by trained technicians using the Monitoring Services Application.

The CardioNet Ambulatory ECG Monitor with Arrhythmia Detection intended use is for: - Patients who have a demonstrated need for cardiac monitoring. These may include but are not limited to patients who require monitoring for: a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACs, PSVT) and ventricular ectopy; b) evaluation of bradyarrhythmias and intermittent bundle branch block, including after cardiovascular surgery and myocardial infarction; and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease - Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath). - Patients with palpitations with or without known arrhythmias to obtain correlation of rhythm with symptoms. - Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation). - Patients recovering from cardiac surgery who are indicated for outpatient arrhythmia monitoring. - Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive, central) to evaluate possible nocturnal arrhythmias - Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or atrial flutter - Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT interval changes

The CardioNet ECG Monitor with Arrhythmia Detection is an ambulatory ECG monitor with capability to detect cardiac arrhythmias and transmit ECG data to a CardioNet staffed monitoring center. The subject device is comprised of three (3) main components: 1) a patient-worn Sensor, 2) a Monitor and 3) a charging Base. A Sensor acquires the ECG signal from the patient's body and transmits the signal to PDA sized monitor where the data is stored and analyzed by an automated arrhythmia analysis algorithm. When an arrhythmic event is defected the monitor can transmit the ECG data to the monitoring center utilizing a cellular modem or telephone data line. The patient can also initiate the recording and transmission of ECG data if symptoms are felt. The data is received and reviewed by trained technicians using the Monitoring Services Application.

1. Patients who have demonstrated a need for cardiac monitoring and are at low risk of developing primary ventricular fibrillation or sustained ventricular tachycardia. 2. Patients with dizziness or lightheadedness 3. Patients with palpitations 4. Patients with syncope of unknown etiology 5. Patients who require monitoring for non life-threatening arrhythmias, such as atrial fibrillation, other supra-ventricular arrhythmias, evaluation of various bradvarrhythmias and intermittent bundle branch block. This includes post operative monitoring for these rhythms 6. Patients recovering from coronary artery bypass graft (CABG) surgery who require monitoring for arrhythmias 7 . Patients requiring monitoring for arrhythmias inducing co-morbid conditions such as hyperthyroidism or chronic lung disease 8. Patients with obstructive sleep apnea to evaluate possible nocturnal arrhythmias 9. Patients requiring arrhythmia evaluation for etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation 10. Data from the device may be used by another device to analyze, measure or report QT interval. The device is not intended to sound any alarms for QT changes.

The CardioNet Arrhythmia Detector which is also referred to as the subject device, is a modification to the CardioNet Ambulatory ECG monitor cleared by FDA under 510(k) number K003707, in May 2001. The subject device includes the addition of an ECG analysis capability that allows detection of cardiac arrhythmia. As described in the previous 510(k) the subject device is comprised of three components: 1) a patient-worn Sensor, 2) a Monitor and 3) a charging Base. The Sensor acquires the ECG signal from the patient's body. It is connected to electrodes attached to the patient's skin. It is suspended in place by a neck strap. The ECG signal is conditioned, filtered, digitized and transmitted to the Monitor via Radio Frequency bi-directional communications. The Sensor utilizes a disposable AAA battery. The Monitor receives, analyzes, stores and transmits the ECG data. The Monitor has an LCD display and handles the user interaction for the system. The Monitor has an integrated cellular modem to allow communications with and without physical connection to a phone line. The Monitor has a re-chargeable battery. When an ECG threshold is exceeded or if the patient initiates a call, the ECG data is transmitted to the CardioNet Monitoring Center where trained clinical personnel review the data. The Monitor Center can also request data from the Monitor, the Monitor will transmit ECG data are requested. All ECG data for the past 24 hours is resident on the Monitor and can be transmitted to the Monitoring Center as requested by Monitoring Center Personnel. The subject device utilizes the proven Mortara ECG analysis algorithm that is currently used in the Quinton Q-tel telemetry system, 510(k) number K003576, 807.1025, Procode DSI, Class III; and the Datex-Ohmeda CS/3 telemetry system, 510(k) number K000882, 807.1025, Procode DSI, Class III. The Quinton Q-tel telemetry system and the Datex-Ohmeda telemetry system are both Class III Preamendments devices for which FDA has not yet requested PMAs. The Base provides power, RS232, and telephone communication connectivity to allow telephone transmission of ECG data when in the Monitor is charging. The Base does not include any software; it is a passive component that provides input to the Monitor.