Artisan’s Asylum Autoclave Shield

Model Description

Model ID 3DPX-013374Category Labware & DevicesDevice Use Safety and Personal Protective EquipmentKeyword(s) COVID-19 PPE face shieldA laser cut or 3D printed shield frame that can adapt to a variety of shield designs. Originally based off of the Scale Workspace reusable face shield, but optimized for mass production due to the near tesselation of the print. Nesting the print enables significant cycle time improvements. Currently produced in Somerville, MA (near Boston, MA) at Artisan's Asylum and provided to local health groups for testing. The original design that this design is based on, has been produced in New Orleans and provided to Ochsner in excess of 1350 QTY shipped and heavily tested. Features:Top section covered to prevent droplets from above the forehead1 minute laser cut times out of 1/8" Polypropylene on a 90W laserSpace for safety goggles, and a respiratorAccess for a stethoscopeAll materials are industry standard for autoclave sterilization (and UV safe, bleach safe, etc..)Bill of Materials:1/8" Polypropylene (if 3D printed, suggest PC filament for autoclave use)0.04" Polycarbonate (PC) or Polyethylene terephthalate (PET or PET-G) for the visor cut. Transparency can be used but provides insufficient coverage.Silicone comfort strip, optional, e.g. Mcmaster #4869A2Silicone O-ring, elastic hair tie, or rubber bandsThe FDA has authorized production of protective face shields outside of the normal clearance pathway during the Covid-19 pandemic, based on Part 5, section D of the “Enforcement Policy for Face Masks and Respirators During the Coronavirus Disease (COVID-19) Public Health Emergency Guidance for Industry and Food and Drug Administration Staff.This face shield has undergone review in a clinical setting and is recommended when fabricated as instructed.3D Modeling/CAD Software SolidworksPrinter Technology/Material OtherPrinter Make/Model Prusa Mk3Print Units mmThis device is a general purpose face shield 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 model sourced with permission from the NIH 3D Print Exchange*

Files

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TDP Category Type Filename Size
General Instructions application/pdf IFU_Rev2.pdf 321.48 KB
General Instructions application/pdf images.pdf 713.11 KB
Native CAD Frame_0.dxf 105.20 KB
Native CAD Nested Frames.dxf 641.25 KB
Native CAD Visor_Stack_0.dxf 47.83 KB
STL File visor2_0.STL 96.96 KB
Blender-generated-x3d visor2_0.STL60c0b76e7b600.x3d 60.80 KB

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Part Information

Additional Owner's Names

jsaly

AMCPR Type

designPackage

Model Number

3DPX-013374

Review Process

simple

Public

Yes
2021-06-09T12:43:03

Materials

Polymer

General Build Material

PC

Quality Standards

Submission Path

production

Assembly Required

No
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