Sani-Mask by Nemotech - NIH 3D Print Exchange | …



Sani-Mask by Nemotech - Instructions for UseThese instructions for use correspond to Revision 12 of Sani-Mask.Appropriate Use CriteriaThis supplementary 3D Printed face mask was created as an emergency action in effort to provide protection as a backup Personal Protective Equipment (PPE) option if the traditional PPE devices have become unavailable. This device has not gone through the same regulatory approval process as traditional PPE, but has gone through a special verification process expedited strictly for the response to the COVID-19 pandemic. This device is intended to be used only for the duration of the public health emergency related to COVID-19 declared by the Department of Health and Human Services (HHS), including any renewals made by the HHS Secretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act).The decision to implement this device should be made with careful consideration and under the consultation of the corresponding institution’s occupational health and infection control departments. The information included in this document provides device description and feature overview, recommended assembly steps, and cleaning instructions for reuse. Device OverviewFig 1.The Sani-Mask is a 3d printed mask design that is printed in polypropylene via a single wall or “vase mode”. The mask has been shown to be successfully sterilized of bacteria when inoculated and put through sterilization methods (more on methods below). The mask consists of 3 sterilizable parts – 3d printed polypropylene face mask frame, 3d printed polypropylene filter retaining ring, and ? inch silicone rubber straps. The 4th component is the filter medium, which can be any flat filter medium. The filter medium is not intended for reuse, and must be replaced after each sterilization. Assembly guide is located at strapping is ? inch silicone “food bands”. One example is at material will need to be purchased separately. Nemotech makes no specific recommendations as to material, and suggests researching efficacy of available solutions before choosing.The Sani-Mask has proven to be capable of elimination of bacteria, even after significant inoculation. Tested methods include autoclave, isopropyl alcohol, household bleach, and sani-wipes. 50/50 household bleach and water was found to be the easiest to impliment. See Appendix A for recommended disinfecting solutions and sterilization methods for this device. See Appendix B for guidelines on material selection. Components to be disposed of after every use or immediately after potential contamination by bodily fluids: Filter mediumComponents to be disinfected and reused: Polypropylene maskPolypropylene filter retaining ringSilicone head strapsFig. 2Point of Care Assembly and Cleaning InstructionsFor instruction on how to properly assemble, clean, and reassemble for reuse of the Sani-Mask, please refer to the steps outlined below. Assembly StepsVIDEO ASSEMBLY GUIDE LOCATED AT all assembly in a clean environment wearing nitrile gloves and face covering. When delivering to outside parties, ensure a clean method of transportation such as a ziploc bag. CleaningThe recommended materials selected for making the reusable components of this Sani-Mask have a proven track record for remaining stable during and after the use of the list of disinfectants and sterilization process outlined in Appendix A. However, there has been no formal testing completed yet to support the claim that the use of disinfectants alone is a sufficient cleaning approach against the COVID19 virus specifically on the surface of this material. Because of this, it is recommended that the following disinfection and sterilization steps are performed after each user is finished using the Sani-Mask and the user has followed the proper procedures for doffing the device.Autoclave50/50 Household bleach and waterSani-WipeIsopropyl alcohol 93%Preparing the Supplementary Mask for Reuse. Remove and discard filter medium in a proper trash recepticle.Prepare cleaning solution using above table. Use a large enough container to contain the entire mask assemblySubmerge mask assembly completely in solution. Allow mask to stay submerged for 20 minutes, agitating occasionally to ensure the solution reaches all surfaces.Remove mask from solution and rinse with clean waterInsert mask into clean covered container such as plastic ware, or ziploc bagMask is now considered safe for re-useInstall new filter medium before usingAppendix A: Recommended Disinfectants and Sterilization MethodsFrom FDA guidelines on HYPERLINK ""Enforcement Policy for Sterilizers, Disinfectant Devices, and AirPurifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency releasedMarch 2020 it is recommended that “this policy is intended to remain in effectonly for the duration of the public health emergency related to COVID-19 declared by theDepartment of Health and Human Services (HHS), including any renewals made by the HHSSecretary in accordance with section 319(a)(2) of the Public Health Service Act (PHS Act)”. Thepolicy recommends to use an approved disinfection agent as it should “minimize the viability ofSARS-CoV-2” on the surface of the Sani-MaskRecommended Disinfecting Agents:From the EPA guidelines in List N: Disinfectants for Use Against SARS-CoV-2, it is recommended to use the following solutions for the disinfecting procedures of this device.Autoclave – following standard cycle and temperature for polypropylene50/50 household bleach and water for 20 minutesSani-Wipe93% isopropyl alcoholRecommended Sterilization Method: Below is a table outlining the sterilization parameters that are recommended to be used for autoclave sterilization processing. autoclave cycle – 121 degrees celcius at 15 psi for 20 minutesVisually inspect mask after autoclaving to ensure no large scale physical deformity has occurred that could lead to a reduction in efficacy.Recommended to dispose of mask if physical deformity is observedAppendix B: Recommended Materials3D printer – Any FFF/FDM model compatible with standard GCODE, and capable of holding 250c on the hotend, and 50c on the bed.Polypropylene filament – Smart Materials Spain adhesive – Smart Materials “Smart-Stick” Spain head straps – ? inch silicone “food bands” C: Materials in Direct Contact with SkinPolypropylene face maskSilicone food band ................
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