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The zensor monitoring device is a small, lightweight, wearable battery operated system connected to an electrode accessory (single-use disposable Intelesens zensor Electrode Array) which in turn is in contact with the patient's body. The device is to be used in the home environment to provide clinicians with patient physiological data. The zensor monitoring system provides full disclosure ECG and cardiac event monitoring for adult patients. The zensor monitoring system displays ECG and respiration waveforms from the reserver. The system monitors the following configurable physiological parameters: Heart Rate, as well as key cardiac arrhythmias, and a patient activated recording. The zensor monitoring system has the option to store full disclosure ECG. Respiration and accelerometer data and/or wirelessly transmit pre-defined event alerts to the Intelesens zensoronine system for review by healthcare practitioners. All physiological data stored on the device can be imported for viewing on Intelesens zensor+ (Ambulatory Full Disclosure ECG and Event Viewer) for later analysis by a clinician.

The zensor system includes the following components: - zensor device a wireless (Wi-Fi) monitoring device . - . Adherent electrode array Software - . zensor App for configuration of device settings - . zensoronline web based monitoring application identical to Canberra cleared in K110015 and K131000 except for name change and support of zensor functionality. - zensor+, full disclosure and event data viewing PC software . The zensor also includes a standalone battery charger. Charging does not / cannot occur when the zensor device is connected to a patient. The zensor device monitors physiological parameters and is a wireless, wearable ECG and respiratory monitor. It is a small, battery-operated system comprised of the zensor monitoring unit (a body worn transmitter device), the zensor electrode array, and zensor battery pack. The zensor device is connected to the electrode array via magnetic studs, and the array is positioned as appropriate on the patient's body. The electrode array consists of three patch electrodes containing conductive gel and is self-adhesive and will adhere to the patient's skin. The zensor device communicates to a remote data base using Wi-Fi or mobile hotspot. The rechargeable battery pack contains a rechargeable 3.7V lithium ion battery to power the zensor device. The battery pack is charged using the zensor single bay charging dock. When fully charged the life of the battery pack can be up to three days (dependent on device configuration). The physiological parameters monitored include ECG and respiration waveforms, heart rate and respiration rate, activity, detection of cardiac arrhythmias (Asystole, Tachycardia, Ventricular Fibrillation, Bradycardia and Atrial Fibrillation) and recording of patient-activated events. The zensor monitoring device has the option to store full disclosure ECG and respiration data and/or wirelessly transmit pre-defined event alerts or patient-activated recordings to the Intelesens zensor online system for review by healthcare practitioners. All physiological data stored on the device can be downloaded for viewing on Intelesens zensor+ (Ambulatory Full Disclosure ECG and Event Viewer) for later analysis by a clinician. The device also contains on-board ECG arrhythmia detection algorithms to automatically record and send ECG data on detection of one or more of the following arrhythmias: - asystole, ● - . ventricular fibrillation, (VF) - bradycardia - atrial fibrillation (AF) ● - tachycardia ● Accelerometer: The zensor device incorporates a digital accelerometer MEMS (Micro Electro Mechanical System). This is used to monitor 3-axis acceleration, providing information on patient activity. Electrode Array - The zensor electrode array is a patient worn adhesive sensor that facilitates the ● acquisition of ECG (3 lead) and respiration signals. - The array is placed onto the patient following the instructions detailed in the user manual. - . The array consists of three electrodes and 5 magnetic studs for connecting to the device. zensor electrode array has the same patient contact materials as the V-Patch electrode (K131000)

The Intelesens V-Patch System is designed to monitor and transmit ECG data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare or home environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation. The re-usable device is intended to be used with a single use electrode on the patient for up to seven days. The V-Patch System uses an on-board ECG arrhythmia detection algorithm to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the host application at user defined intervals or upon the detection of an arrhythmia event. The V-Patch also has a patient activated button that allows ECG to be recorded and transmitted on-demand should the patient experience any relevant symptoms.

The V-Patch device is a small, lightweight wearable device that is connected to an accessory electrode that is applied to the patient's body. The electrodes are a proprietary Intelesens design. The patient wearable monitor is named the V-Pod operates on user replaceable coin cells. The device wirelessly transmits physiological data relating to ECG and heart rate to a receiving station - the V-Cell via a wireless ANT connection. The V-Cell interfaces to the Internet via GPRS allowing for web-based analysis by a clinician on the Canberra System. There are also on-board algorithms that continuously monitor for, and record ECG on detection of nine cardiac arrhythmias and a patient activated event button. The cardiac arrhythmias detected are: - . Bradyarrhythmia - . Ventricular Tachycardia - . Supraventricular Tachycardia - Ventricular Fibrillation . - . Atrial Flutter - . Atrial Fibrillation - l st degree Heart Block . - . 2nd degree Heart Block - . 3rd degree Heart Block

The Intelesens Vital Signs Monitor Aingeal (VS200) is used to monitor and transmit physiological data to a web based host application for display or analysis by a clinician. The device can be worn by ambulatory or non-ambulatory adult patients in a healthcare environment to support clinical staff when they are carrying out their routine observations or when a patient would otherwise be in an unmonitored or unobserved situation. This re-usable device is intended to be used on the patient for short term periods only. The device is intended to be used on adult patients for monitoring of ECG, respiration, heart rate, skin temperature and activity levels in a healthcare setting. The device can be used where information on ECG, respiration, heart rate, skin temperature, and activity levels would be useful. The device uses on-board ECG arrhythmia detection algorithms to automatically record and send ECG data if the user is suspected to be experiencing an arrhythmia event. The device transmits the data to the host application at user defined intervals or upon the detection of an arrhythmia event.

The Aingeal (VS200) is a small, lightweight wearable device that is connected to an accessory electrode that is applied to the patient's body. The device wirelessly transmits physiological data relating to ECG, heart rate, respiration, skin temperature and motion to a receiving station via a WiFi connection for display or for analysis by a clinician. The device alerts clinicians when a patient's heart rate changes outside of pre-defined that can be modified by clinical staff. There are also on-board algorithms that continuously monitor for, and record ECG on detection of seven cardiac arrhythmias.