Smart Check O2 (MA0236)

The Smart Check O2 is a handheld ultrasonic oxygen analyzer used by durable medical equipment technicians to verify the performance of oxygen concentrators during servicing or repair. It measures oxygen purity, flow rate, and pressure at the concentrator outlet. It is not patient-contacting and is intended for use in hospitals, nursing homes, extended care facilities, patient homes, and respiratory device service centers.

The device uses ultrasonic upstream/downstream time-of-flight measurement to determine gas flow and oxygen concentration. It is battery-operated (2× AA alkaline cells), firmware-controlled, employs piezo-electric ultrasonic transducers, and features a segmented LCD display with backlight. It measures oxygen (20.9–96%, ±1.5% accuracy), flow (0–10 LPM, ±0.2 LPM accuracy), pressure (0–40 PSI), and pulse volume (3–200 ml) for pulsing concentrators—the latter being a new feature absent in the predicate.

ANSI AAMI ES60601-1:2005 (general safety and essential performance); ANSI AAMI HA60601-1-11:2015 (home healthcare environment requirements); ANSI AAMI IEC 60601-1-2:2014 (electromagnetic disturbances); ISO 80601-2-55:2018 (respiratory gas monitor requirements). All standards include recent amendments (2021–2023).

The Smart Check O2 uses identical measurement technology (ultrasonic time-of-flight) and achieves the same oxygen, flow, and pressure measurement specifications as the predicate Maxtec UltraMax analyzer. Minor differences (backlit display, wider operating temperature range, improved pressure range, pulse volume capability) represent incremental improvements or direct compliance with the homecare standard ANSI/AAMI HA60601-1-11, and do not introduce new risks. The pulse volume feature uses repeated application of the same flow measurement method, merely integrating the data differently—no new measurement principle or hazard is created.