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PeraMobile Indications for Use: The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to provide a patient status index. The Rothman Index is a single measure of a patient's physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient's vital signs, nursing assessments, and selected lab values. PeraMobile is indicated for use by healthcare providers within the hospital for displaying and/or trending Rothman Index (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support. PeraMobile is intended for use in the hospital to support Rapid Response Team clinicians or other dedicated clinical response staff responsible for pro-actively rounding on patients of concern and/or providing support to bed-side clinicians. PeraWatch Indications for Use: The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to provide a patient status index. The Rothman Index is a single measure of a patient's physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient's vital signs, nursing assessments, and selected lab values. PeraWatch is indicated for use by healthcare providers whenever there is need within the hospital for displaying and/or trending Rothman Index (RI) scores and displaying associated configurable warning states as an adjunct to clinical decision support. PeraWatch is intended to support clinicians in surveilling patients throughout the hospital setting (e.g. in the emergency department, on the wards, in intensive care units) and across multiple hospitals in a centralized and/or remote professional clinical surveillance setting.

PeraMobile is an interactive mobile application that provides an interface to display RI scores, trends, and configurable warnings for selected groups of patients within the hospital. PeraMobile reads and writes data directly to and from the PeraServer database. Designed for mobile clinicians, PeraMobile functionality also allows end-users to document both pre-defined interventions and free text notes that are stored in PeraServer and accessible through the user interface within PeraMobile. PeraServer was previously cleared in K172969. PeraWatch is a read-only, web-based graphical user interface for displaying Rothman Index scores, trends and configurable warnings. PeraWatch reads data directly from the PeraServer database. PeraMobile and PeraWatch are software-only devices that are installed on user-provided hardware that supports IEEE 802.11b or higher (802.11ac is recommended).

The Rothman Index uses commonly recorded vital sign, nursing assessment, and lab data to compute a patient status index. The Rothman Index is a single measure of a patient's physiologic condition based on the aggregate statistical mortality risk associated with the values of the patient's vital signs, nursing assessments, and selected lab values. PeraServer is indicated for use wherever there is interest in generating Rothman Index (RI) scores and/or associated configurable warnings. PeraTrend is indicated for use by healthcare providers whenever there is need for displaying and/or trending RI scores and displaying associated configurable warning states as an adjunct to clinical decision support. PeraServer/PeraTrend is intended for the care of patients throughout the hospital setting (e.g., in the emergency department, on the wards, in intensive care units). The Rothman Index score is validated for use with neonatal, pediatric, and adult patients. It is an adjunct-to and is not intended to replace vital signs monitoring and is not intended for use in the Neonatal Intensive Care Unit.

The subject of this submission is the PeraServer and PeraTrend System, consisting of: - PeraServer a backend hardware/software platform that imports electronic health record ● (EHR) data, which are used to compute and store Rothman Index (RI) scores and related measures - PeraTrend – the frontend web-based user interfaces for displaying RI scores and related measures, as well as simple manipulations of the display (i.e., graphical representations over time, comparison of Rothman Index scores and input measures) PeraServer and PeraTrend are software-only devices that are installed on user-provided hardware.