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Vitals360® device is intended to be used for measuring, displaying, reviewing and storing of non-invasive blood pressure (NIBP), non-invasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), forehead temperature (TEMP), ECG, weight and height in adults no less than 18 years of age. This VITALS360® device is intended for use by trained adults only who can use smartphones proficiently. This VITALS360® device is intended for use in a clinical or home environment. This VITALS360® device is a reusable device following thorough cleaning between uses.

The Vitals360® is a device designed for spot-checking measuring of the patient's physiological parameters. It can monitor the patient's blood oxygen saturation (SpO2) and pulse rate (PR) non-invasively by the photoelectric method. It can also measure non-invasive blood pressures of systolic and diastolic) by the oscillating method and body temperature (TEMP) by the infrared radiation energy technology. Additionally, it can record single lead ECG signal. The Vitals360® capabilities include storing, displaying measuring data.

The VoCare MyHealth Tablet™ is a remote patient monitor device available by prescription. The VoCare MyHealth Tablet™ is designed to be used in the home of a patient undergoing remote monitoring for maintenance of chronic disease. The VoCare MyHealth Tablet™ provides quidance in operating medical sensor devices, reminders for medication compliance and connectivity to healthcare professionals through text messaging and realtime video conferencing technology. The VoCare MyHealth Tablet™ connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters. The VoCare MyHealth Tablet™ stores and displays the information on the LCD screen and transmits the information to the VoCare secure host server using FCC approved Wi-Fi or Ethernet. Healthcare professionals can review the transmitted information utilizing the VoCare Clinician Access System and set thresholds to trigger alerts based on specific thresholds being exceeded. The VoCare System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. The data is made available to the patients when timecritical care is not required. The device is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Judgment and experience by a caregiver or by a family member are required to check and interpret the information delivered. A list of devices that are compatible with the VoCare MyHealth Tablet™ will be available in the user's manual and the VoCare website.

The VoCare MyHealth Tablet™ is a remote patient monitoring device available via prescription. The VoCare MyHealth Tablet™ connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters, stores and displays the information on the LCD screen and transmits the information to the VoCare secure server. Healthcare professionals can review the transmitted information utilizing the VoCare Clinician Access System. The VoCare System consists of: 1. VoCare System Hardware: The physical component of VoCare System is the VoCare MyHealth Tablet™, which is an electronic device contained in an acrylonitrile butadiene styrene (ABS) thermoplastic enclosure with a touch screen, built-in video camera, microphone, speaker, and a reminder light mounted on top left corner of the case. The VoCare MyHealth Tablet™ contains front and back panels that provide standard USB 2.0 connectors, Ethernet connector, power connector and power button, as well as volume controls. 2. VoCare MyHealth Tablet™ Software Application: The VoCare MyHealth Tablet™ executes the VoCare MyHealth Tablet™ Software Application, which connects to commercially available wireless and tethered glucose meters, weight scales, blood pressure monitors and pulse oximeters, stores and displays the information on the LCD screen and transmits the information to the VoCare secure server. 3. VoCare Clinician Access System (CAS) Software Application: The VoCare Clinician Access System (CAS), which is associated with and manages multiple VoCare MyHealth Tablet™ devices, is designed to allow doctors and nurses to create and access electronic health records as well as provide a user-friendly interface into a patient's health condition. The VoCare System is not intended for diagnosis or as a substitute for medical care, and it is not intended to provide real time data. It is made available to patients when, timecritical care is not required. The system is contraindicated for patients requiring direct medical supervision or emergency intervention. The system is intended for patients who are willing and capable of managing its use. Clinical judgment and experience by a caregiver are required to check and interpret the information delivered.