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The intended use of the Zyter RPM is to provide an interface with physiological patient monitoring systems to forward recorded device information to the patient's healthcare provider. Zyter RPM does not alter the behavior of the primary medical devices and associated alert annunciations. Zyter RPM is not intended to be used for diagnostic purposes. Zyter RPM is intended for use by professional clinical personnel and relies on proper use and operation of both the communication infrastructure in place at the use environment (e.g., healthcare facility or home setting) and the display interface used. Zyter RPM is a software product and cannot come into physical contact with patients.

Zyter RPM is a Software as a Medical Device (SaMD) intended to provide healthcare professionals with supplemental information about events and alerts originating from medical devices, or other event or alert producing systems within a clinical or home setting. This device can route notifications including all or a subset of the event or alert information along with related contextual information to selected end points such as but not limited to mobile phones, or other computing or communications end points. Zyter RPM is intended to provide remote central monitoring and display of information as recorded by multiple specifically compatible FDA cleared devices on a central screen and to provider alert and alert notifications on the screen and to other provider devices. The Zyter RPM software application will receive, aggregate, process, distribute and display parameters, alerts, and events at locations other than at the patient for multiple patients. Information provided by the Zyter RPM software is not intended for diagnosis or active patient monitoring where immediate action is required. Receipt of notifications by the end point is not confirmed, and delivery to the end point is not guaranteed. The primary alert notification is the device or system producing the alert or event. Zyter RPM is not intended to directly diagnose or treat patients or to be used in the prevention of a disease or condition, nor does Zyter RPM come into direct contact with patients. Zyter RPM serves as a convenient user interface to integrate data and provide health care professionals the ability to access and monitor parameters of devices and data that have been cleared by the FDA. Zyter RPM does not affect the intended use, or alter the indications for use, for the cleared devices with which it is intended to function. The Zyter RPM has two separate user interfaces: one is the provider web application and the second is the patient mobile application. The patient mobile application is used by patient-users along with their assigned medical devices to see their own health data and send device readings to their provider. The web application is used by healthcare providers to manage their patients, receive alerts and view their patient's medical data. Zyter RPM is comprised of two main components: - Mobile App (for patient users) - Web App (for healthcare provider users) The patient mobile application is used by patient-users along with their assigned medical devices to see their own health data and send device readings to their provider. The web application is used by healthcare providers to manage their patients, receive alerts and view their patient's medical data. The patient-user is provided with a pre-configured Zyter Tablet for remote health monitoring. The patientuser may also choose to use their own smartphone and download the Zyter Mobile App. The patient is also assigned a number of health devices by their healthcare provider. The patient-user is responsible for connecting the health devices to the Zyter Tablet (or mobile phone). Pairing of the health devices with the tablet (or mobile phone) ensures wireless communication between both devices. Instructions for connecting health devices to the patient mobile app are included in the patient app guide. Zyter RPM mobile application also has a functionality that allows the patient to schedule a tele-visit with their healthcare provider. The patient may choose to take a self-assessment questionnaire found in the Zyter RPM prior to scheduling a visit. Zyter RPM is a digital healthcare platform that automatically collects and routes data from the patient's pre-configured, compatible, at-home medical devices (blood pressure cuffs, glucometers, thermometers, digital weight scales, and smart watches) to the hospital office via a 4G cellular or Wireless connection. The health devices are configured to a user in the Zyter user management using the Device Mac address. Zyter validation algorithm doesn't allow the duplicate Mac address entries. Zyter RPM provides patients with Tablets pre-installed with Zyter mobile application. Users connect with the wireless health devices through the mobile app. Zyter also supports BYOD model where patients use their own mobile devices to install the Zyter app from the App store and Google Play store to connect with the wireless devices. Zyter RPM supports two transmission protocols, device data transmission through Bluetooth technology where the Bluetooth device needs to be paired with the mobile app and the 4G/LTE devices where the device data is transmitted to Zyter via device cloud via APIs and no device pairing required. Zyter RPM achieves EMR connectivity using on-prem or on-cloud solutions. The vitals reading from the health devices are securely processed through device SDKs/APIs and they are accessed through the patient and provider RPM dashboard. The Zyter RPM Dashboard enables the monitoring of multiple patients with an information tab for each patient. All physiological patient data, plus alerts and notifications from each patient's RPM devices, go directly to the dashboard for physician review, as well as intervention via a telehealth virtual visit if a patient's readings are out of the normal range. Physicians can also configure alerts for custom parameters of device readings for individual patients. Zyter RPM devices also send alerts to the physician dashboard, email and SMS, and a reminder to the patient's Zyter RPM app, if a device has been dormant for a pre-determined amount of time. Physicians can set a Zyter RPM alert based on any patient device reading that is out of range. Depending on the device(s) the patient receives, alert ranges can be set to measure the following values: - BP (Systolic), mmHg - BP (Diastolic), mmHg - Pulse Oximeter, % Sp02 - Temperature, Fº or Cº - Weight Scale, lbs - Blood Glucose, mmoI/L Zyter RPM is compatible with the following medical devices and accessories: BodyTrace Blood Pressure Monitor K131395 iHealth BP Monitor - iHealth Track (KN550BT) K160014 BodyTrace Weighing Scale N/A - Wellness device iHealth Weighing Scale N/A - Wellness device Smart Meter iGlucose Blood Glucose Monitor Starter Kit K161790 iHealth Blood Glucose - iHealth Gluco + (BG5s): K181070 iHealth Thermometer PT3 K202753 iHealth Air Pulse Oximeter - iHealth Air (PO3M): K131111 Nonin Pulse Oximeter K131021 Apple Health Kit N/A - Apple Health System Samsung Android Tablet