Fetal Monitors: Evaluation Criteria and Test Methods

September 21, 2016 | Evaluations & Guidance


In our Evaluations of fetal monitors, we assess four broad features of the systems: performance, alarm indicators, device human factors, and data management.

Under performance, we look at the ability of the device to track variability over a wide range of heart rates, and to detect heart rate coincidence which occurs when the same signal is displayed in two different parameter fields as heart rate from two sources.

We assess the adequacy of alarm indicators on the devices, as well as the ease of silencing and disabling the alarms. We also assess the ease of basic monitoring operation, including visibility of the various measurements. Finally, we assess the ability of the...

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