(58 days)
Datalys Multi-Parameter Patient Monitor 750, 760, 780 are intended to monitor basic physiological parameters of patients within any professional medical environment. The user, responsible for interpreting the monitored data made available, will be a licensed healthcare practitioner. Physiological data, system alarms, and patient data will be the user from the monitor.
The monitor models monitor parameters such as ECG (3-lead), Respiration (RESP), pulse oximetry (SpO2), noninvasive blood pressure (NIBP) and surface body and rectal temperature (TEMP) only. The models are equipped with alarms that indicate system faults, physiological parameters that have exceeded the limits set by the operator, or both.
The monitor models do not measure, display or trend changes in the ST segment, do not detect arrhythmia or provide arrhythmia alarm, and is not intended for use as an apnea monitor. The models are not intended for use during MRI or CT scans.
The monitor models are not designed for home use, and are restricted to be used on one patient at a time.
The device has not been tested for and it is not intended for pediatric use.
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This document is an FDA 510(k) clearance letter for the Datalys Multi-parameter Patient Monitor 750, 760, 780. It does not contain information about acceptance criteria or a study proving that the device meets those criteria.
Therefore, I cannot provide the requested information based on the given input. The document primarily focuses on regulatory approval and indications for use.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).