Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

The CX10, CX12, CX15, UX10, UX12, and UX15 patient monitors are multiparameter physiological monitoring devices intended for continuous monitoring of adults, pediatrics, and neonates in hospital environments. They measure ECG, respiration, temperature, blood oxygen saturation, pulse rate, blood pressure (invasive and non-invasive), carbon dioxide, and cardiac output, with arrhythmia detection and ST-segment analysis for adult patients only.

The subject devices are nearly identical to the predicate iX series in core design and specifications. Minor differences include: respiration measurement range revised from 0-200 rpm to 6-200 rpm with specified accuracy; CO2 measurement range increased from 150 to 152 mmHg; removal of Anaesthesia gas (AG) monitoring; SpO2 pulse rate range adjusted from 25-300 bpm to 20-300 bpm; and addition of F3000 temperature module option alongside the existing T2A module.

IEC 60601-1:2020 (general safety), IEC 60601-1-2:2014 (electromagnetic compatibility), IEC 60601-1-8:2020 (alarm systems), IEC 60601-2-27:2011 (ECG monitoring), IEC 60601-2-34:2011 (invasive blood pressure), IEC 80601-2-30:2018 (non-invasive blood pressure), IEC 80601-2-49:2018 (multifunction monitoring), ISO 80601-2-55:2018 (respiratory gas), ISO 80601-2-56:2017+A1:2018 (thermometers), ISO 80601-2-61:2017 (pulse oximetry), and IEEE ANSI USEMCSC C63.27 (wireless coexistence).

The subject devices share the same fundamental design, operating principles, and measurement technologies as the predicate iX series. The identified differences are limited to minor parameter specification adjustments (measurement ranges, accuracy tolerances, optional modules) that do not alter the underlying scientific technology or raise new questions about safety and effectiveness. Bench testing confirms the subject device meets its accuracy specifications and relevant consensus standards, demonstrating equivalent performance to the predicate.