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The Vital Signs Patch (VSP) system is intended to be used on patients in a clinical environment for the continuous, noninvasive monitoring of ECG, Heart Rate (HR), respiration rate, surface temperature, and arterial blood oxygen saturation (intended use group adults 21 and above), when prescribed by a physician or other qualified healthcare professional.

The Vital Signs Patch (VSP in short) system is designed to monitor selected vital signs of patients in a clinical environment. The VSP system is comprised of the following components: Physical Patch, Brain - VSP Transmitter, Gateway mobile device, Clinical Backend. The Patch is attached to the patient's chest. The Brain plugs into a cradle on the Patch and is connected to the Patch with a 16-pin connector. The Brain receives the power from the Pattery; the data from the sensors are transmitted using the 16-pin connector. The Gateway includes a dedicated, medical SW application (also known as the Gateway application) designed by LifeWatch Technologies. The Brain transmits data to the Gateway application using the RF component. The patient can manually trigger an event by the pressing a button on the Brain. In addition, the Brain contains a 32MB Flash memory chip that can store 6-10 hours of data in case of communication failure with the Gateway. All data received from the Brain is recorded and stored on the Gateway. In addition, the Gateway can be used to view vital sign signals received from the Brain and to transmit the data to a Monitoring Center via the internet by the Wi-Fi network. The VSP is not intended for use on patients with life threatening arrhythmias; hence it is not intended for patients in the ICU. The internal LifeWatch Technologies Ltd. Part Number of the Vital Signs Patch system is CG-1101B; this model serves also as the predicate device (cleared in K132407) for this Special submission.

The ECG Mini System Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center provides the ECG data to the medical practitioner for evaluation. The device has not been tested for and it is not intended for pediatric use.

The ECG Mini System Continuous ECG Monitor and Arrhythmia Detector ("ECG Mini") is a system that records ECG data and detects defined arrhythmias. It is comprised of a disposable 1-lead ECG Patch which includes a processing/transmitting module called a "Brain", and a cellular device (also called "Gateway"). The ECG Patch has 3 electrodes which are used to obtain a 1-lead ECG that is used for arrhythmia detection. The ECG Patch is placed on the upper left side of the chest according to the instructions and guidance in the Patient User Guide (UG-00105). The ECG Mini system consists of following three components: - . Patch: Disposable 1-lead Patch with ECG electrodes - Brain: Reusable processing and transmitter device - . Gateway Cellular Device: Communicates data to the Monitoring Center

The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arthythmia. The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm, or generates an alert manually triggered by the patient, and transmits the recorded data trans-telephonically to a monitoring center provides the ECG data to the medical practitioner for evaluation. The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended to be prescribed for patients who have demonstrated a need for cardiac monitoring and are at low risk of developing life-threatening arrhythmias. Conditions where the system should not be used include patients likely to experience primary Ventricular Fibrillation or Ventricular Tachycardia and patients who have other co-morbid cardiovascular conditions where an arrhythmia could be potentially life threatening. This device has not been tested for and it is not intended for pediatric use.

The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center. The chest-worn sensor is used for the acquisition, recording, and transmission of the ECG signal. The device is equipped with 4 electrodes on a harness and it houses a 3.6V AA battery, a Bluetooth transceiver and a patient alert buzzer. The ECG signals are transmitted via Bluetooth to a handheld device with a proprietary interactive application, configured to process and transmit the ECG recordings. The handheld device is a mobile computing device with a display and a touch input such as a cell phone. It has sufficient memory and processing capability to run the proprietary application. When an arrhythmia event is detected, the handheld device transmits the recorded ECG information automatically via cellular link, to the Monitoring Center for professional analysis. When cellular service is unavailable the patient has an option to transmit via a landline telephone. The modification that led to this submission was the change from a mobile platform with a Windows-based OS to one with an Android-based OS.