Frequently Asked Questions
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.
Prices vary by region and sales channel. Contact tdenevan@safermedicalproducts.com.
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.
Absolutely. Our team of four emergency physicians, one emergency nurse practitioner, and four full-time sales personnel are happy to provide complete training wherever and whenever needed.
Use protocols for the system are included with the products and can also be found online at https://safermedicalproducts.com/documentation/.
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.
In fact, CFD findings indicate a 40% increase in delivery of nebulized medicines with our system. This is due to the air drawn in through the shields that increases the dosage concentration.
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.
The SafER system was designed to work with the majority of respiratory equipment currently in use such as nebulizers, high flow nasal cannula, CPAP/BPAP circuits, and laryngoscopes.
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.
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.
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.
The system draws air into the shields and through the HEPA or ULPA filters located on top of the vacuum. The filtered air is then expelled out the vacuum’s side exhaust ports.
No. The vacuum uses a top mounted HEPA or ULPA filter that is provided in each shield kit.
The filter lasts for 24 hours of continuous use.
The system’s battery takes 1.5 hours to reach full charge. When plugged in, the battery charges during operation. A fully charged battery lasts 1 to 1.5 hours.
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.
The vacuum weighs 6 pounds; The Respiratory shield and Endoshields each weigh less than a pound.
The system runs on lithium-ion batteries.
There are no comparable systems available on the market in terms of efficacy, portability, cost, or convenience.
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.
While COVID-inspired, the benefits of the SafER Negative Pressure System extend beyond, to any respiratory use to help mitigate and contain other airborne pathogens.