ANNE View, Central Hub

The ANNE View, Central Hub is a bedside patient monitoring system that displays physiological data (ECG, heart rate, respiratory rate, SpO2, blood pressure, temperature, and body position) from compatible sensors and third-party devices. It operates on a tablet and can transmit data wirelessly to a central monitoring hub for viewing and storing vital signs from up to 16 patients simultaneously, with alarming capabilities when data fall outside configured thresholds.

The device uses Android 14.0 operating system on the ANNE View tablet and Windows 11 for the Central Hub desktop application. Communication occurs via Bluetooth between the tablet and sensors, and LAN/WLAN between the tablet and Central Hub. It provides real-time monitoring with data storage capability up to 48 hours per patient and includes both visual and auditory alarms.

Electromagnetic compatibility (IEC 60601-1-2:2020), wireless coexistence (ANSI IEEE C63.27-2017), software verification and validation (IEC 62304:2015), ECG waveform display verification (IEC 60601-2-27:2011 and IEC 60601-2-47:2012), usability testing (IEC 62366-1:2020), cybersecurity evaluation per FDA guidance, alarm system verification (IEC 60601-1-8:2020), and performance evaluation of HL7 FHIR and IEEE 11073 SDC communication protocols.

The device demonstrates substantial equivalence through functional and technological parity with predicates: it displays real-time physiological data for patient monitoring in non-critical care settings like the predicates, employs comparable communication methods (Bluetooth and network-based transmission), provides equivalent alarm functionality, and serves the same intended user population (trained healthcare professionals). The performance testing across recognized consensus standards confirms safety and effectiveness equivalent to the predicate devices despite minor differences in operating system versions and the addition of interoperability with third-party FDA-cleared devices.