The Stryker Flyte™ Personal Protection System, as marketed by Stryker™, includes a full-body garment and a helmet with a visor to wear on one’s head. This sanitary protective garment for performing surgeries has a built-in fan, light and microphone, but lacks N95-compliant air filtering. As-is, this otherwise state-of the-art medical surgical gear is the wrong tool for fighting a pandemic disease that may be transmittable by air. But, if upgraded to include a particulate-screening air filter, this protective clothing gear could be very useful in protecting wearers when treating patients with communicable viruses.

Under the direction of Dr. Thomas Ahlberg, MD, of St. Francis Memorial Hospital in San Francisco, CA, Scansite has engineered and manufactured a replacement component that fits with standard models of this suit.

As it currently exists, this garment features an open grid plastic fan cover that snaps into place on top of the helmet that additionally serves as a structural support.

The AIR INTAKE ADAPTOR FILTER replaces this component.  The AIR INTAKE ADAPTOR FILTER is closed except for a 90mm opening and attaches easily onto the helmet of the surgical suit. An N95 filter (or other suitable material) is then placed over the opening and secured using an elastic band, thus covering it completely, and thereby causing air coming into the suit to be filtered by passage through the opening. Once the ADAPTOR FILTER is in place and the intake fan turned on, a positive pressure is created that forces the air down and away from the user. The AIR INTAKE ADAPTOR FILTER upgrades the suit into personal protective gear that also provides N95-compliant filtering.

OFF LABEL DEVICE DISCLOSURE STATEMENT

The Stryker Steri-Shield Flyte Toga/Hood™ is a component of the Stryker Personal Protection System™ and is intended to protect the patient, healthcare personnel and operating room personnel against contamination, exposure of infectious bodily fluids, and the transfer of microorganism and particulate material. The Flyte™ PPE products are not cleared as respiratory protective products. CDC guidance for respiratory protection directs the use of an N95 or higher rated mask for staff performing Aerosol Generating Procedures. In the context of PPE, respiratory devices are devices that protect the wearer from inhalation of a hazardous atmosphere at a prescribed level. Stryker PPE products do not provide this level of respiratory protection. The hoods and togas are intended to provide resistance to blood-borne pathogens and nonaerosolized viral penetration whereas the N95 Respirator provide respiratory protection. N95 respirators can be used under any Stryker hood or toga.

The Air Intake Adaptor Filter is an off-label device, created as an urgent response the COVID-19 virus pandemic, that has not yet been cleared through the FDA for marketed use. The adaptor has not been designed by or approved for use by the manufacturer of the Stryker™ Flyte™ suit (The Stryker™ Corporation, East Lansing, MI).

When using the Air Intake Adaptor Filter, with the addition of filtration material covering the opening, there is a decrease in air flow and pressure within the toga.   This decreased air flow may result in higher levels of CO2 under the disposable hood. (Whereas in the standard, Stryker™ FDA-approved system, Stryker™ tests to and adheres to OSHA requirements for permissible CO2 exposure limits.)  Scansite emaphasizes the need for healthcare workers using the Air Intake Adaptor filter to be sensitive to the way they feel during use. Increased levels of CO2 can lead to headaches, fatigue, eye and throat irritation, impaired function, and, in severe cases, seizures or loss of consciousness. Users should take periodic breaks and remove the system to balance their breathing and flush CO2 away from the face.

The additional filter material causes the fan to work harder.  The effect, if any, on the life expectancy of the fan is unknown. The hot glue used to attach the Adaptor can be removed using Ethanol (rubbing alcohol) however, some cosmetic staining of the Stryker unit and the Adaptor may occur. Altering the Stryker™ Flyte™ device may affect or void warranty.

The AIR INTAKE FILTER ADAPTOR was designed using accepted engineering standards and is produced through a commercial grade, 3D additive manufacturing process. Scansite has partnered with Stratasys (https://www.stratasys.com/) a world leader in commercial additive manufacturing to produce the units. Stratasys has the capacity to 3D print as many AIR INTAKE ADAPTOR FILTERS as needed, extremely quickly. All units sold will include adhesive to bond the ADAPTOR to the helmet and create an airtight seal.

Scansite * 1595 Francisco Blvd E, suite D * San Rafael, CA * 94901 * www.scansite.com * 415.488.9500

DISCLAIMER:  This product represented here in not manufactured by, designed by, sold by or approved by the Stryker(TM) Corporation .  This product represented here has not been tested or approved by the U. S. Food & Drug Administration.  No claims, representations or warranties, whether express or implied, are made by the inventors or their companies as to the safety, reliability, durability and performance of this product.