Sleepiz One+ (Model 2.5)

The Sleepiz One+ (Model 2.5) is a non-invasive, contactless cardiotachometer with a rate alarm, specifically designed for passive monitoring of heart rate and respiration rate in adult patients during rest or sleep. It is not intended for active patient monitoring, emergency alarms, or life-threatening situations, meaning it lacks real-time intervention capabilities. This device is ideal for clinical or home settings where continuous, indirect physiological data collection is needed without direct patient contact, such as sleep studies or long-term trend analysis.

The Sleepiz One+ (Model 2.5) is explicitly designed for single-use only, as stated in its description. Since it is supplied sterile, proper handling and storage must follow standard sterile medical device protocols to ensure patient safety. Single-use devices like this are typically discarded after one use to prevent cross-contamination and maintain hygiene standards.

The Sleepiz One+ (Model 2.5) is authorized under FDA 510(k) clearance and MDR compliance, classifying it as a Class II medical device. This means it has undergone regulatory review to ensure safety and effectiveness for its intended use—passive monitoring of heart and respiration rates. Its prescription-only status indicates it should only be used under medical supervision, though it is not intended for emergency or life-threatening scenarios. The regulatory route ensures it meets stringent standards for clinical or home use.

Unlike traditional cardiac monitors that often require direct electrode contact or invasive sensors, the Sleepiz One+ (Model 2.5) is fully contactless, using passive monitoring technology to track heart rate and respiration without physical attachment. This design eliminates the need for gel, wires, or skin preparation, reducing patient discomfort and simplifying setup—particularly beneficial for long-term or overnight use. It is ideal for scenarios where ease of use and minimal patient interaction are priorities.