Search Results

The Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense is used with compatible bed system models and is intended for continuous measurement of respiration rate (RR) in an automatic, contactless manner. The system is indicated for use in children, adolescents, and adults in hospitals or clinical settings. It is intended to be used for the same patient populations and the same settings, within these ranges, as the bed with which it is used. The system has been validated to withstand up to 700 lb (318 kg).

The Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense is designed for continuous and contact-free measurement of heart and respiratory rate (also referred to as Bed Sensing Unit). This device is used with a hospital bed system which is exempt from 510(k) premarket submission requirements. The Bed Sensing Unit (sensor) plugs into the bed frame to both receive power and to transmit data. Data from the System is available on the bed's graphical caregiver interface (GCI)/display unit and can be transmitted through wired and wireless communication channels to Hillrom Connectivity Solution (also known as (aka)- Hillrom Digital Health Gateway) for display, use, and storage. Additionally, the System can transmit alerts via Bloetooth to an existing hardwired Nurse Call system, speakers, and/or on/off alert lights within a bed system. The healthcare professional can adjust monitoring parameters by interacting with the bed's GCI. These parameters include hospital-defined alert thresholds, display settings, and alert configurations. The system provides alerts when patient heart rate and/or respiratory rate are recorded that are above or below the predefined thresholds. The Hillrom Heart and Respiration Rate Monitoring System powered by EarlySense consists of: - . The Bed Sensing Unit, placed on a bed frame under the mattress - This is functionally identical to the sensor cleared in K202018 - - Software for data analysis, display, and input ● - The software for data analysis is identical to that cleared in K202018 - - The software for display and input is identical to the software cleared in -K202018 - The device hardware, specifically the connection between the sensor and • appropriate bed system - The hardware for the device is identical to that cleared in K202018 - - The Heart and Respiration Rate Monitoring System also uses certain hardware, such as the graphical caregiver interface and wireless communication module, of an appropriate bed system - Hillrom Connectivity Solution (aka Hillrom Digital Health Gateway) . - The Hillrom Digital Health Gateway consists of gateways that make information about the bed and patient available to 3rd party applications. This is functionally identical to that cleared in K202018.