GE Additive Community Face Mask Frame

Model ID 3DPX-013512Category Labware & DevicesDevice Use General Equipment or AdapterKeyword(s) face Mask 3D print Simple FastGE Additive Community Face Mask Collection Label: PN4212AS0294-1-AM GE ADDITIVE FACE MASK COLLECTION See the attached Technical Data Package in the Documentation tab for detailed manufacturing and use instructions. This device is a general purpose face mask intended for use in the community and is not suitable for use by a healthcare professional or in a healthcare facility or environment, as described in FDA Guidance Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, Section V B. This device has not been tested to assess the out-gassing limits of the material or their corresponding health effects. Simple DIY mask with flexible filter media options. Three sizes available; small, medium and large. Each one can be printed in less than 15 minutes. Use string, elastic cord, rubber bands, or other options to secure to head. Any FDM 3D printer can produce these frames. User can select filter material to be used, (Cotton, Air filter, Rag, Hayland H600 etc.) Anchors around the frame are very handy to wrap string around for a snug fit. Mask frame will conform under tension, or can be heated and formed to the face. ****Ultimate goal is a low cost, fast printing, simple face mask with flexible filter material options that could be reused or discarded.****"Make everything as simple as possible, but not simpler." Einstein PRECAUTIONS: THIS ITEM IS INTENDED FOR REUSE PROVIDED THAT IT IS PROPERLY DISINFECTED BETWEEN EACH USE BY APPLYING CLEANSER FOR DISINFECTING PLASTIC PRODUCTS (E.G. CAVICIDE) AND WASHING OR REPLACING FILTER MATERIALS AND ELASTIC BANDS IN ACCORDANCE WITH USER INSTRUCTIONS. NON-CLOTH FILTER MATERIALS SHOULD NOT BE PLACED DIRECTLY IN CONTACT WITH SKIN. NON-CLOTH FILTER MATERIALS SHOULD NOT CONTAIN FIBERGLASS. ADVERSE REACTIONS: EXTENDED USE OF THIS ITEM MAY CAUSE DISCOMFORT OR IRRITATION OF THE SKIN. THIS DEVICE HAS NOT BEEN CLINICALLY TESTED PLEASE REPORT ADVERSE REACTIONS TO THE MANUFACTURER OR TO NAVY_AM_COVID19@NAVY.MIL.3D Modeling/CAD Software SolidworksPrinter Technology/Material Material Extrusion Polylactic Acid (PLA)Printer Make/Model Prusa i3 MK2SPrint Units mmScale At Given Print Units No ScalePre- and Postprocessing Instructions 1) Print DIY Face Mask on any FDM machine2) Using cutting template cut Cloth or acceptable filter material3) Clean DIY Face Mask Frame to CDC standards https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html4) Optional : Conform DIY Face Mask Frame to users face. https://youtu.be/wVRS_5bWIiw5) How to wear mask https://www.youtube.com/watch?v=OVpRneFTqiYReviewer Notes This device is a general purpose face mask intended for use in the community and is not suitable for use by a healthcare professional or in a healthcare facility or environment, as described in FDA Guidance Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency, Section V B. This device has not been tested to assess the out-gassing limits of the material or their corresponding health effects.*These models sourced with permission from the NIH 3D Print Exchange*