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The Circadia C200 System is intended for the measurement of respiratory rate and heart rate, including spot measurement. The system is indicated for adult patients in clinical settings, such as skilled nursing and long-term care facilities. The system is not indicated for active patient monitoring, and does not provide alarms for timely response in acute lifethreatening situations. The system is not intended to monitor heart rate in patients with arrhythmias. The system is intended to be used by healthcare professionals (HCPs) and data are intended by HCPs to inform patient care. The system also monitors patient motion, and patient presence or absence near the device (exits).

The Circadia C200 System is a contactless system that uses radar to monitor respiratory rate (RR), heart rate (HR), motion, and presence of a patient in its detection range. The System is designed to monitor a patient automatically, without the need for the patient to wear or do anything, or for a healthcare professional (HCP) to interact with the device. The System is thus suitable for long-term and unsupervised monitoring. The System may also be used to obtain on-demand spot measurements of heart rate and respiratory rate. This allows HCPs to control the frequency and timing of these measurements using the C200 System. The System consists of the Circadia Contactless Cardiorespiratory Monitor (the "Monitor"), the Circadia Cloud Service (the "Cloud Service"), and the Circadia Pro App (the "App"). The Monitor may be installed next to a patient's bedside. It uses a radar-based motion sensor to detect micromotions caused by ventilation and heartbeat, to measure a patient's RR and HR while the patient is in its detection range at rest. Data is processed continuously on the Monitor, and streamed to the Cloud Service over a Wi-Fi network. The Cloud Service offers a set of Application Programming Interfaces (APIs) that allows the Monitor to connect to the server and send data over a secure channel. In addition, it allows for patient data to be retrieved from the App. The App allows a healthcare professional to retrospectively review RR and HR data from multiple connected Monitors. Motion and presence/exit data are available in real time. The App operates from an Android tablet (not supplied, not included in the System). The App includes a functionality to notify a user if no HR has been obtained within the most recent 8 hours.

The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-lead ECG, heart rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure and activity. VMS allows for the input of body temperature, and can display data from peripheral devices. VMS can generate alerts when the physiological vital signs fall outside of selected parameters. VMS can also generate alerts when cardias arrhythmias (Tachycardia, Asystole, Ventricular Fibrillation and Atrial Fibrillation/ Atrial Flutter) are detected. The ECG rhythm analysis is intended for use by medified professionals in the identification of arrhythmia events and to aid in clinical review of arrhythmias and medical interventions. The Vos CSM/CS Software is indicated for use by healthcare professionals for the purpose of centralized monitoring of patient data within a healthcare facility. The Vios CSMCS SW receives, stores, and displays patient physiological and waveform data and alams generated by Vios proprietary patient vitals monitoring software.

The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals. The VMS includes a proprietary monitoring software, Chest Sensor, Finger Adapter and Central Server and Central Monitoring Station. The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices. The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile multiple use,

The Neteera 130H-Plus device is intended for spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring) and inform on bed exit. The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care. The Neteera device is not intended to be used as an alarm system for potentially acute life-threatening situations in which medical intervention is necessary (e.g., ICU).

Neteera 130H-Plus device is a modification of the predicate device Neteera 130H (K212143). It is a contact-free vital-signs monitor based on a high frequency (122.25-123 GHz) micro-radar on-chip and algorithm, capable of detecting Respiration Rate (RR) and Heart Rate (HR) during rest or subject's mild body movement, with the additional capability of identifying and notifying on bed exit. Neteera's micro- radar-based solution enables remote measurement, in real-time, in a non-invasive and contact-free manner. The system works by measuring only the ballistocardiograph micro-movements of of the skin (BCG) through nonmetallic materials such as furniture and clothing at a high resolution, and it has several different mounting options and measuring ranges.

Sleepiz One+ is a contactless medical device intended to measure heart rate and respiration rate in adult patients, at rest or during sleep (in non-motion condition). The Sleepiz One+ hardware unit is intended to be used by a healthcare professional when the recordings are performed in a clinical setting, or by patients or their caregivers when the recordings are performed in a home environment. The Sleepiz One+ web application is Intended for use by healthcare professionals. Sleepiz One+ device can also detect the presence of patients and their body movements at rest or during sleep. This device is not indicated for active patient monitoring, as it does not provide alarms for timely response in life-threatening situations. It is not indicated for use on pregnant women or patients with active implantable devices.

Sleepiz One+ is a contactless medical device that uses radar technology to measure respiration rate and heart rate. The device is placed on a bedside table or a stand, mounted slightly higher than the mattress level, from where it detects the presence of a patient and their physiological signals. From that position, distance changes between the device and the patient's body are captured by Doppler radar. The recorded signals are then transmitted to the cloud software where these are analyzed by the signal processing software ("Sleep Analytics Software") to obtain respiration rate, heart rate and facilitate the monitoring of the presence of the patient and their body movement. These outputs are then displayed on the web application to allow the annotation of the data, compilation of results into reports, and the management of the hardware units.

The Neteera 130H/131H device is intended for spot and continuous measurement of heart rate and respiration rate in adult patients (in healthcare facilities and home monitoring). The indications provided are to be used by health care professionals and are intended to be reviewed by clinicians to inform patient care. The Neteera device is not intended to be used as an alarm system for potentially acute life-threatening situations in which medical intervention is necessary (e.g., ICU).

Neteera 130H/131H device is a contact-free vital-signs monitor based on a high frequency (122.25-123 GHz) micro-radar on-chip and algorithm, capable of detecting a variety of parameters: Respiration Rate (RR), Heart Rate (HR), during rest or subject's mild body movement. Neteera's micro radar-based solution enables measuring the micro-motions of the skin (BCG-Ballistocardiograph) remotely, in a real-time, non-invasive, and non-contact manner, through non-metallic materials such as furniture and clothing at a high resolution.

The Ivy Biomedical Model 7600EP/7800EP is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party diagnostic imaging systems that require ECG synchronization, such as nuclear medicine, computed axial (CAT), or positron emission (PET) tomography and other imaging systems requiring similar cardiac cycle specific timing. The Ivy Biomedical Model 7600EP/7800EP monitors can also be used to provide cardiac trigger pulse output used by a third-party ablation and lithotripsy systems.

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The Vital Sign Monitoring Sensor (Model XK300) is intended to measure heart rate and respiration rate in adult patients in a general care hospital environment including nursing homes. The Vital Sign Monitoring Sensor can be used for home healthcare for data collection to inform patient care but not to acutely treat a patient. XK300 monitors presence or absence of a patient in detection area of within 7 meters. The XK30 also monitors the length of continuous patient motion or absence of patient motion.

The Vital Sign Monitoring Sensor (Model XK300) measures heart rate, respiratory rate (breathing rate), and movement of people with very little or no movement (rest mode) using Impulse Radio Ultra-Wideband (IR UWB) radar technology. The heart rate and respiratory rate are measured by detecting minute displacements of the chest and converting the movement into the number of breaths and heart beats per minute.

The Philips wearable biosensor-G5 is indicated for single patient use whenever heart rate measurement is needed in noncritical hospital settings. The Philips wearable biosensor-G5 solution is used as a higher resolution heart rate log by nurses or physicians retrospectively as an aid in making non-ife threatening therapeutic decisions. The biosensor is intended for patients who are 18 years of age or older. The G5 Biosensor is intended only for patients with a baseline narrow QRS complex (less than 100 ms).

Philips wearable biosensor-G5 Solution is a physiological sensing solution that gathers and stores a patient's heart rate. Philips wearable biosensor-G5 Solution is comprised of the: - Philips wearable biosensor-G5 - and data visualization application "G5 application" ● The Philips wearable biosensor-G5 is a battery operated, single-use device, measuring heart rate by continuously acquiring surface electrical waveforms related to cardiac excitations and measuring beat-to-beat intervals when a patient is stationary or ambulatory. The sensor functions by capturing and then sending physiological data wirelessly to the software application. The sensor's frequency of data collection and transmission is configurable. The G5 application receives and displays data from the Philips wearable biosensor-G5 providing a user interface and exportable file for retrospective review and analysis.The G5 Biosensor is intended only for patients with a baseline narrow QRS complex (less than 100 ms).

The Vios Monitoring System (VMS) is intended for use by medically qualified personnel for physiological vital signs monitoring of adult (18+) patients in healthcare facilities. It is indicated for use in monitoring of 7-lead ECG, heart rate, respiratory rate, pulse rate, functional oxygen saturation of arterial hemoglobin, non-invasive blood pressure, and patient posture and activity. VMS allows for the input of body temperature, and can display data from peripheral devices. VMS can generate alerts when rate-based carthythmias are detected and when physiological vital signs fall outside of selected parameters.

The Vios Monitoring System (VMS) Model 2050 is a wireless mobile medical device platform that allows caregivers in healthcare settings to monitor patient vitals. VMS includes Vios-proprietary monitoring software and a Vios-proprietary vitals sensor with two Vios-proprietary adapters. It is compatible with a medical grade, Bluetooth™-enabled NIBP cuff. The VMS BSM SW Model B2050 is stand-alone software that can receive, analyze, and display physiological vitals data from one or more patient-worn sensors via standard communication protocols (Bluetooth™). It runs on a commercial IT platform and is intended to be used in conjunction with the Vios Chest Sensor and Vios Lead Adapters and can support peripheral, medical grade, Bluetooth™-enabled devices. The VMS Chest Sensor Model CS2050 is a small, patient-worn, non-sterile, multiple use, and rechargeable sensor that acquires 3-channel ECG, bioimpedance, 2-channel pulse oximetry, and tri-axial accelerometer data. The sensor contains signal acquisition firmware (embedded software) and wirelessly communicates acquired data via standard communication protocols (Bluetooth™) to the BSM SW for analysis and display. The Chest Sensor has a button that, when pressed, sends a patient call alert to the BSM SW. VMS Chest Sensor Adapter Models L2050E (Pulse Ox Ear Adapter) and L2050F (Pulse Ox Finger Adapter) are plastic, non-sterile, patient-worn, multiple use pulse oxygenation sensors that connect to the Vios Chest Sensor and are secured to the patient via medical grade ECG electrodes.

The Ivy Biomedical Model 7600, 7800 is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party systems that require ECG synchronization is commonly used in diagnostic imaging modalities (i.e., nuclear medicine, computed axial (CAT), or positron emission (PET) tomography) or other applications requiring such synchronization. The Model 7600/7800 is intended for use in neonatal, pediatric and adult patients undergoing diagnostic imaging and related procedures in inpatient and outpatient centers under the supervision of licensed healthcare professionals. The product is not intended for use as a life support, home monitoring, or magnetic resonance imaging (MRI) modality.

The Ivy Biomedical Model 7600, 7800 is a basic cardiac monitor used to provide cardiac trigger pulse outputs used by third-party systems that require ECG synchronization.