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The Carecube is now available for purchase! Following rigorous testing and evaluation, we're proud to share that the Carecube has received FDA 510(k) clearance in the US.
The Carecube is designed with specific usage guidelines to ensure safety and efficacy. While the Carecube Negative Pressure Isolation Chamber Canopy is intended for multi-patient use with a maximum of ten (10) patients, it's important to note that certain components are intended for single patient use only. Additionally, the Carecube itself is intended to be used by a single patient for up to 24 hours of continuous use. These usage instructions are in place to maintain the highest standards of patient care and infection control.
The Carecube is designed to maintain a negative pressure of ≤ -2.5 pascals and provides 15 or more air exchanges per hour, meeting the CDC guidance for airborne infection isolation rooms (AIIRs). Air is drawn into the device through intake filters on the roof and then passes through an H14 HEPA filter, which removes 99.997% of particulates at 0.3 micrometers. To ensure proper negative pressure, the Carecube includes a manometer with a visual alarm.
The Carecube has undergone rigorous testing to ensure its safety, efficacy, and compliance with industry standards. These tests have been conducted by reputable third-party test services including Intertek, Mesa 3, Nelson Labs, and DDL.