Is it FDA or NIOSH approved?
- No, our masks are not approved by the FDA or NIOSH or any other state or federal regulatory body, but we’ve tested them rigorously to make sure they serve medical professionals that are serving us!
- The CDC has recently approved “homemade masks” for crisis management and shortages of approved materials.
Is this a replacement for an N95 mask?
N95 masks are still the recommended personal protection equipment (PPE). In situations where N95 masks are in short supply or not available, we recommend that each hospital or individual using these masks run a complete fit test with the support of hospital administrators. The filtration efficiency of the mask will vary with the material inserted into the filter casing.
This is not an FDA or NIOSH approved N95 product and should be tested and fit to your local hospital standard.
Have these masks undergone OSHA fit testing?
Although we have performed the tests required per OSHA standards for this equipment, this is not an FDA or NIOSH approved product. All our research findings indicate that this mask passes or exceeds standard test requirements for filtration. Please see our research.
How much does it cost to create the mask? Can I sell it?
When printing in PLA, this mask can be created for around $1 per mask for materials. Other filaments have a different price structure, but we would like to stress the fact that these files have provisional patents and are for open source use only. If you choose to sell the mask to cover the cost of your materials, we recommend a price cap of $2 per mask. If you chose to pursue injection molding production, please note that the patents on these molding CAD files are to ensure that production is limited not-for-profit ventures that operate at cost to serve their local community. No licensing will be awarded to for-profit ventures.
Can I print it for a larger or smaller face size?
Yes, use the scaling feature on your printer to adjust the X, Y, and Z dimensions.
Will the mask cause CO2 buildup?
During our test , the mask did not cause CO2 levels to rise. This test was conducted on a healthy individual with no existing pulmonary complications. If you have respiratory issues, this mask, or any mask, may not be recommended for use.
What kind of 3D printer do I need to use?
Any 3D printer that has a big enough build platform should be able to create the mask. Most printers are compatible, but please download the files to verify.
How long does it take to print?
This varies greatly depending on your printer, settings, and chosen material. When printing in PLA at the settings below, it can take around 3 hours to print. Other printers and materials can vary from 2-9 hours to complete.
What are the printer settings that you recommend?
When it comes to settings, every printer is different. Please download the files and allow your printer to adjust to the optimal settings, or just use your traditional settings. For our printing process, we have used:
- 25-30% infill
- Suggested height layer of .1 to .2 mm
- Built without supports
What materials do you recommend for production?
We have been using and testing in PLA. ABS, Nylon, and SLA printers using a basic liquid resin would also function well, but all masks need to undergo inspection and fit testing prior to use. Improper fit reduces filtration efficiency. Some printers have found that TPU provides a flexible, comfortable fit, and we are working to provide test results as to the efficiency.
How many masks can you create with a 1kg spool of material?
We have found that we can use about 30-33 meters of filament per mask, which yields 20-22 masks per 1 Kg spool.
Can I print these using flexible resin?
We have not yet tried flexible resin. If you try it, please document your findings and email us! UPDATE: Our supporters that have tried traditional resin found that it was NOT an effective material for this mask. Thanks for your feedback!
Can I change or modify the mask design files?
We encourage local innovation. You are welcome to use these files to build off of and utilize the tools you have on hand. PLEASE NOTE: all research and tests conducted for the Montana masks follow these exact design files specifically. Any modifications will void the associated research and require a complete workup of testing.
I have made a Montana Mask by following the design on your site. Now what?
1. GREAT WORK! Thank you for adding your time and energy to this effort. 2. Post a pictures of you and your mask and tag us #makercause and #makethemasks
3. Follow the instructions above to get your local hospital to approve use of the mask.
Which filters do you recommend?
We recommend using 2.5” squares cut from surgical masks. One N95 surgical mask will yield six filters with surgical protection and will yield a greater filtration depending on the fit. Other creative filter materials have not been tested by us, but could be considered in extreme circumstances.
Where can I order filters?
We recommend using local supply of N95 masks, surgical masks or other N95 rated material for filters, but if they are not available, please check with local filter supply companies to seek out alternatives. We don’t currently recommend manufacturing any filters and do not have access to N95 material for distribution.
Can I contact you with my ideas for improvements or assist with new updates and design?
We encourage everyone to make their own masks and discuss innovation within their community. We are not hosting a forum for discussion on design suggestions and innovations at this time. Check back to this site for updates on files as we continue to test and modify our designs. Each mask must be tested and fit to an individual provider, so as you make improvements on your own, please remember that all the tests only apply to the exact design posted on our site.
FAQ FOR HEALTHCARE WORKERS & MASK USERS
My medical facility has received some Montana Masks, what do I do now?
- After receiving masks from any source, all pieces must be disinfected per government guidelines – https://www.ncbi.nlm.nih.gov/books/NBK214361/
- Insert N95 material into the filter casing (or other filtration material available)
- Perform necessary fit testing and other inspections to ensure personal fit and seal to a specific provider.
PLEASE NOTE: Proper sanitizing sequences are absolutely critical to proper usage of any mask.
How do I properly don and doff the Montana Mask?
- Your hospital should review and adopt a robust procedure for use and ensure they are recommending a proper donning and doffing protocol for this mask.
- Not following your individual employer hospital-approved guidelines for donning and doffing could result in cross-contamination.
How can I get my health care organization to approve and use these?
- Approach your local clinics/hospitals/nursing homes, etc to see if they are experiencing a shortage. If they are interested, make a contact with someone within the facility and work through them when delivering your mask.
- Print out the DELIVERY PACKET pdf (Link coming soon) and bring it with you when delivering the masks. This information will explain to the administration all of the rigorous testing performed on the mask how they can best utilize it.
- Have an official hospital representative sign the Transfer of Liability form before releasing the masks.
- Please refer them to the website with any questions or concerns.