Cardiac Workstation (5000); Cardiac Workstation (7000)

The Cardiac Workstation 5000 and 7000 are electrocardiograph devices that acquire multi-channel ECG signals from adult and pediatric patients via body surface electrodes, then record, display, analyze, and store these signals for clinician review. The devices use the Philips DXL ECG algorithm to provide measurements, data presentations, and interpretations on an advisory basis; a qualified physician must over-read and validate the computer-generated interpretation.

Compared to the predicate PageWriter TC70, the Cardiac Workstations offer improved ECG analog-to-digital resolution (12 to 24 bit), higher digital processing rate (500 to 1000 samples per second), extended signal bandwidth (0.02–300 Hz vs. 0.05–150 Hz), updated wireless support (802.11ac/WiFi 5), migration from end-of-support WinCE operating system to Linux with FIPS 140-2 encryption and SMB V2/V3 security, and larger display options (12.1 inch for CW5000; 15.6 and 18.5 inches for CW7000). Both use the same cleared ECG algorithm (PH110C) and patient cable.

ANSI/AAMI ES60601-1:2005/A1:2012 (medical electrical equipment general safety), ANSI AAMI IEC 60601-1-2:2014 (EMC), ANSI AAMI IEC 60601-2-25:2011 (electrocardiograph particular requirements), IEC 60601-1-6:2010 (usability), IEC 62366-1:2015 (usability engineering), ANSI AAMI IEC 62304:2006 (software life cycle), ANSI C63.27:2021 (wireless coexistence), ISO 14971:2019 (risk management), ISO 15223-1:2021 and ISO 20417:2021 (labeling and symbols).

The devices are substantially equivalent because they share identical indications for use, patient population, use environment, and fundamental ECG signal acquisition and processing technology with the predicate TC70. The improvements—higher signal resolution, faster processing, extended bandwidth, updated wireless protocol, and enhanced security—do not change the intended function or introduce new safety risks; instead, they represent modernization of supporting technologies while maintaining the same cleared core ECG algorithm, same patient cable, and equivalent safety and EMC classifications. Non-clinical bench testing confirmed performance claims across software, environment, reliability, and human factors.