Legal Disclaimer
This product design and specifications are being provided by the University of Wisconsin-Madison College of Engineering as a free service to the community during this public health emergency.
Regulatory Notice
This product has not been cleared for medical use by the U.S. Food and Drug Administration. The product should only be used during the declared COVID-19 public health emergency if FDA cleared or approved products are unavailable. This product has not been evaluated for the prevention of specific diseases or infections, the filtering of surgical smoke or plumes, the filtering of specific amounts of viruses or bacteria, or the killing or reduction of the amount of viruses, bacteria or fungi. Not recommended for use in a surgical setting where exposure to liquid, bodily or other hazardous fluids may be expected or for use in a clinical setting where infection risk level through inhalation exposure is high. Not recommended for use in the presence of a high intensity heat source or flammable gas. [This product is intended for one-time use by a single user.]
Liability Notice
By using this product, the end user assumes all risks associated with its use, including the voiding of manufacturers’ warranties of devices with which the product is used, and agrees to hold harmless and waive any claims against the Board of Regents of the University of Wisconsin System, its officers, employees and agents, and other persons or companies which may have contributed to the design and specifications. EXCEPT WHERE SPECIFICALLY PROHIBITED BY LAW, NO WARRANTIES OF ANY KIND ARE OFFERED FOR THE PRODUCT DESIGN AND SPECIFICATIONS, INCLUDING WARRANTIES OF NON-INFRINGEMENT AND FITNESS FOR A PARTICULAR PURPOSE.
Intellectual Property License
Individuals and organizations are free to use, copy, and share this design and specifications, including for commercial manufacture, without payment of any fees or charges, and for the duration of the declared COVID-19 public health emergency only, but may not assert ownership in the design and specifications, ownership of which belongs to the Board of Regents of the University of Wisconsin System and/or the individuals who created the design.
Notice to Manufacturers
Individuals or organizations that manufacture products utilizing this design and specifications are responsible for any federal or state regulatory requirements that apply to the manufacture of products intended for medical use, and are responsible for informing health care providers to which the product is supplied that they are responsible for decisions regarding appropriate personal protective equipment for their personnel. The distribution or sale of products manufactured using this design and specifications must include the Regulatory Notice and the Liability Notice as set forth above displayed prominently on packaging and marketing materials, as well as any information required by the FDA or other governmental authorities.