Yes. The SafER Negative Pressure System is FDA registered and CE listing is scheduled to complete in Q1 of 2022. The Respiratory shield and Endoshield are Class 1 and the vacuum is Class 2, 510k exempt.
How much does the system cost?SafER Admin2022-04-04T13:01:54+00:00
The system is currently used in multiple facilities and EMS agencies and some use it exclusively as part of their respiratory protocol. Across the country, the system is being used on a trial basis and feedback has been overwhelmingly positive. Healthcare professionals’ comment that the system works extremely well and provides an unmatched level of safety for their employees.
Does SafER offer training on the system?SafER Admin2022-03-31T20:59:36+00:00
A computation fluid dynamics (CFD) study has found that the system captures approximately 93% of contaminants, while 6% is re-inhaled by patients, and 1% remains trapped in the system circuitry. The findings of a third-party particle count study soon to be published corroborate these results.
Does the system’s vacuum compromise dosage delivery?SafER Admin2022-03-31T21:08:17+00:00
The Safer system does not replace ventilation or respiratory equipment. However the SafER system is an alternative for traditional negative pressure rooms, providing source control wherever and whenever needed.
Will the system work with existing equipment?SafER Admin2022-04-06T18:28:22+00:00
The vacuum is reusable and can be wiped down with germicidal wipes between patients (according to facility protocols). However, while the shields can be reused with a single patient, they are not designed for use among multiple patients.
Does the system require sterilization?SafER Admin2022-04-01T14:18:13+00:00
The system doesn’t require sterilization and can be cleaned with the germicidal agents and protocols currently in use at a facility. For more aggressive cleaning, the system can be prepped with a mild detergent on a damp cloth.
How is the system maintained?SafER Admin2022-04-01T14:18:39+00:00
The face shields can be cleaned with germicidal wipes after each use but do not require sterilization. The vacuum unit can be wiped down with germicidal wipes or a mild detergent on a damp cloth and should receive an annual biomed check.
How does air flow through the system?SafER Admin2022-04-01T14:19:03+00:00
Since the system’s Respiratory shield and Endoshields are clear and are not in direct contact with a patient’s face, those who are not bothered by nebulizers, high flow oxygen masks or CPAP/BPAP circuits, are unlikely to be bothered by the SafER Negative Pressure System.
How much does the system weigh?SafER Admin2022-04-01T14:20:45+00:00
The real question is where can’t it be used. The system is designed for application in hospitals, clinics, homes, ambulances, planes, ships, etc. and we’re also discovering new scenarios where the system works.
Is the system only used for COVID?SafER Admin2022-04-01T14:22:04+00:00