Search Results

The Biobeat BB-613-BPM is a noninvasive blood pressure monitor which provides a notification to the user every 15 minutes over a 24 hour period for user- initiated measurements. It includes a device and a platform (BPM) for use in adults by healthcare professionals, for collection of pulse rate and tracking changes in blood pressure based on Pulse Wave Transit Time (PWTT) in hospitals, clinics, long-term care and at home. The BB-613-BPM tracks changes in blood pressure and requires callbration using an FDA-cleared oscillometric blood pressure monitor. The data from the Biobeat BB-613-BPM can be accessed through the Biobeat platform for review by a healthcare professional or can be downloaded as a report. The device is not intended to be used on critical care patients.

The Biobeat BB-613-BPM includes a sensor device that is attached to the patient's chest to collect physiological data for later review by their healthcare provider. The device is designed to measure systolic and diastolic blood pressure and pulse rate, in adults, using a noninvasive technique using a light source (LEDs), and sensor array on the backside of the device. Identical to the method cleared in K190792 and in K222010, the LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. This allows measurement of pulse rate, and noninvasive blood pressure. The device is a pre-programmed 24-hour blood pressure monitor (BPM), prompting the use to take measurements at fixed intervals every 15 minutes. In addition, the data is transmitted to a mobile application via Bluetooth and then uploaded to the cloud, accessed through the Biobeat platform for review by a healthcare professional. In addition, the data could be downloaded as a report. The device does not contain any alarms. The device is intended to be used by healthcare professionals and patients in clinical and patient's environments.

The Biobeat Platform-2 is a wireless noninvasive remote monitoring system intended for use by healthcare professionals for spot check collection of physiological data in home and healthcare settings. This can include, functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, blood pressure, respiration rate (RRp), hemodynamic parameters (stroke volume, cardiac output), and body temperature. The Biobeat Platform-2 tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. The Biobeat Platform-2 is intended for spot-checking and tracking changes of adult patients in hospitals, clinics, long-term care, and at home. The data from the Biobeat Platform-2 are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.

The Biobeat Platform-2 includes a sensor device that is attached to the patient's chest to collect physiological data for later review by their healthcare provider. The device consists of a light source (LEDs), thermistors and sensor array on the backside of the device. The LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. This allows measurement of arterial oxygenation, pulse rate, change in blood pressure, stroke volume, cardiac output, and respiration rate. Body temperature is measured by the thermistors. Data is transmitted to a gateway via Bluetooth and then uploaded to the cloud. From the cloud, data is transmitted and presented in a web application for review by a healthcare professional. The device does not contain any alarms.

The Biobeat Platform is a wireless nonitoring system intended for use by healthcare professionals for spot check collection of physiological data in home and healthcare settings. This can include, functional oxygen saturation of arterial hemoglobin (%SpO2), pulse rate, blood pressure, respiration rate (RRp), and body temperature. The Biobeat Platform tracks changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using an FDA-cleared oscillometric blood pressure monitor. The Biobeat Platform is intended for spot-checking changes of adult patients in hospitals, clinics, long-term care, and at home. The Biobeat Platform are intended for use by healthcare professionals as an aid to diagnosis and treatment. The device is not intended for use on critical care patients.

The Biobeat Platform and the BB-613WP Patch sensor include a device that is attached to the patient's chest to collect physiological data for later review by their healthcare provider. The device consists of a light source (LEDs), thermistors and sensor array on the backside of the LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. This allows measurement of arterial oxygenation, pulse rate, change in blood pressure, and respiration rate. Body temperature is measured by the thermistors. Data is transmitted to a gateway via Bluetooth and then uploaded to the cloud. From the cloud, data is transmitted and presented in a web application for review by a healthcare professional. The device does not contain any alarms.

The BB-613 WP is a wrist-worn or skin attached device indicated for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (%SpO₂) and pulse rate. The BB-613WP can also track changes in blood pressure based on Pulse Wave Transit Time (PWTT) which is obtained utilizing pulse measurements from the integrated SpO2 sensor, following a calibration process using oscillometric blood pressure monitor. The BB-613WP is intended for spot-checking of adult patients in hospitals, clinics, long-term care, and home use.

The BB-613WP consists of a light source (LEDs) and sensor array on the backside of the device. The device is available in two versions, a watch version and an adhesive patch version. The LEDs transmit light into the subject's skin and part of this light is reflected from the tissue and detected by a photo-diode. The integrated display is used to display the blood saturation, pulse rate results and changes in blood pressure following calibration. These results are displayed on the LCD screen for the watch version and/or displayed on a mobile application installed on the user's phone. The display also shows symbols that show if there was no signal as well as well as battery status.