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CALM Patterns is intended for use as an adjunct to qualified clinical decision-making during antepartum or intrapartum obstetrical monitoring at ≥36 weeks gestation to obtain annotation of the FHR for baseline, accelerations and decelerations. WARNING: Evaluation of FHR during labor and patient management decisions should not be based solely on CALM Patterns annotations.

CALM Patterns is a computerized method to detect, label and measure features in the fetal monitor recording. CALM Patterns uses fetal monitor data imported through an interface with an external source as described in a previous submission (K980719) or with a third-party clinical information system. CALM Patterns can function in a networked environment or as a standalone workstation.

The CALM system is intended for use as a central monitoring system with signal analysis and display functions and remote repeaters in the perinatal clinical environment. It interfaces with standard fetal and maternal monitors and provides fetal surveillance, monitoring of labor progress, charting, reporting and data analysis, display and archiving functions.

CALM is an easy-to-use system consisting of personal computers, data acquisition modules, and a system server. Interfaced with standard fetal and maternal monitors, CALM helps an Obstetrics Labor and Delivery department with fetal surveillance, charting, and archiving of patient data.