The reusable respirator has not been evaluated by the FDA, and Intermountain 3D makes no warranties as to its efficacy in any specific situation. It is being offered as a stopgap to healthcare providers in this time of shortage. However, great care has been taken to insure the safety of users of the mask.

The reusable face mask developed together with Dr. Ilyas Colombowala MD FACC FHRS, Electrophysiologist, Saint Alphonsus Heart Institute, (that passed testing) must be printed using a manufacturing grade SLS printer and incorporates an added foam seal and filter. Industrial scale SLS printers are required as the masks are very thin allowing for flexibility and close fit.

The idea for the Halyard H600 two-ply spun polypropylene filter came from Dr. Bruce Spiess from UFHealth who co-designed the Montana Masks.

The additive manufactured mask passed N95 equivalent fit-test with Bitrex (surgical wrap as filter, readily available)and can be worn all day unless contaminated. It can be resterilized/reused. The material, according to Dr. Ilyas Colombowala MD FACC FHRS is Nylon-12.

"This solves the problem of the N95 media shortage - this surgical wrap is used to deliver sterilized tools and is abundantly available. We will start shipping this with all our respirators", states Dr. Ilyas Colombowala. He reiterats that masks only perform as described when printed on commercial-grade SLS platform. They require adhesive face seal, filter, and tight elastic straps.Fit testing should be done prior to use.

"Surgical wrap has been proposed as an alternative to N95 filter material by the University of Florida", writes Dr. Ilyas Colombowala. "We tried it, and it works well."

Surgical wrap can be used, according to Dr. Ilyas Colombowala, "which is a good substitute for unavailable filter medium. This is a highly modified and redesigned Montana Mask. Requires SLS printer to achieve specs required for proper fit. The Montana Mask is as a surgical mask substitute." Whereby this mask can be used when N95-masks are not available.

Respirator Components
The reusable respirator is comprised of a 3D printed mask, sealing strip, elastic straps and filter media made from Halyard H600 2-ply spun polypropylene (surgical wrap). Other N95 or equivalent media can also be used.

Respirator Specifications:
Body of respirator is 3D printed using bio-compatible nylon 12 material which has passed the ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity) and ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization) standards
Respirator has been tested with an N95 filter using the N95 Respirator Fit Test with Challenging Agent at St Alphonsus Hospital, and passed all tests.
Respirator has also been tested using filters made of Halyard H600 2-ply spun polypropylene (surgical wrap) and passed all N95 tests
Respirator comes in two sizes, medium and small, and healthcare workers should complete a fit test to determine correct size

Care and Cleaning
Respirator can be wiped clean with water (and soap, if needed) and then sprayed with isopropyl alcohol or hydrogen peroxide and air-dried. Do not immerse the seal in water. Respirator can be reused indefinitely so long as the foam seal is intact
Filter can be reused. However, the filter should be changed after any aerosol-generating procedures, or if it has been contaminated with blood, respiratory or nasal secretions, or bodily fluids from patients

3D Printer Files
These STL Files have been created and optimized for SLS (Selective Laser Sintering) 3D printers. They will likely not print on consumer-grade filament printers due to thin wall regions.

​If you’re looking for something to print with a filament printer, the Montana Mask is aclever design whose CAD is available to download on the website www.makethemasks.com

Ordering
Because supply is limited, the masks are being made available to healthcare personnel and others on the front line of caring for victims of the virus. The masks are shipped with one filter, but medical personnel must have access to their own replacements as needed.

Please contact Lynn This email address is being protected from spambots. You need JavaScript enabled to view it. for further details, ordering and STL files.

DISCLAIMER: The reusable respirator design and assembly have not been evaluated by the FDA or any other regulatory agency, and files are provided here to help in these extraordinary times. Intermountain 3D Inc. makes no representations, warranties, or guarantees regarding the safety, efficacy, or appropriate use of these respirators in any particular situation, and assumes no liability. Each facility should test each batch of respirators prior to relying on them for protection. Use of this information for any purpose is at the maker’s and user’s own risk.