CVHCS Laser Cut or 3D Printable Face shield

Model Description

*This model sourced with permission from the NIH 3D print Exchange*

Model ID
3DPX-013456
Category
Labware & Devices
Device Use
Clinical Equipment or Adapter
Keyword(s)
faceshield; face shield; PPE; reusable, PET-G, Copoly, laser
The following refers to: 3DPX-013456
The 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.
Product Overview
This face shield design is composed of a laser cut PET-G clear shield and laser cut Polypropylene (Copoly) head band. The design is optimized for rapid fabrication and durability. 12 full units per hour can be produced on a 60 watt CO2 laser platform. It is intended to be cleaned and reused as all parts are non-porous. The head band includes a nose piece to support the face shield, reducing the requirement for a tight fit. This means it is more comfortable over long peroids of usage. It does include an elastic or rubber band rear closure to insure the face shield does not fall off, but it does not have to be as tight as designs without a nose piece. The nose pices can be removed if not desired. The Polypropylene (Copoly) frame is flexible, durable and forms well when bent. This allows for a very customizable and comfortable fit for the user.

Although this design is intended for fabrication by laser cutting, the planar nature of the parts and can be easily produced by 3D printing or injection molding.

Product Point of View
Healthcare workers responding to COVID-19 who face PPE (personal protection equipment) supply gaps while waiting for domestic face shield production to catch up with demand NEED a transparent face shield that:
• limits aerosol and splatter exposure from in front and above, while providing top ventilation
• reduces aerosol and splatter exposure on N95 and other face masks
• is re-usable for a single user (can survive multiple daily washes; transparent visor can be replaced from readily sourced materials when worn out)
• is easy to fabricate within a few days of design approval (ie no complex supply chains or production bottlenecks)
• is comfortable to wear and easy to don and doff (as it will be taken on and off dozens of times in a twelve-hour shift)
• provides protection to broader area of face compared to standard safety goggles or glasses
Bill of Materials
• Sheet Polypropylene (Copoly) 3/16” thickness
• Film PET-G up to .016” thickness
• Elastic band, cord, or 3.5” rubber bands (2 per unit)
Instructions for Use and Assembly
1. Laser Cut 3 frame parts (frame, nose, and H-clip) from Polypropylene (CoPoly) and face shield from PET-G or similiar plastic.
2. Attach face shield to headband on the four mounting pegs.
3. Attach elastic to headband C-rings, adjust to fit. Some users may find 1 3.5” rubber band is too tight, consider chaining elastic bands as necessary or using multiple rubber bands.
4. To clean, follow CDC recommendations in Strategies for Optimizing the Supply of Eye Protection - Selected Options for Reprocessing Eye Protection. DO NOT submerge or soak 3D-printed headband in cleaning solution as the headband may absorb the solution and leak it out onto the wearer’s forehead over time.
5. Discard and replace the transparent visor as appropriate, after excessive wear or fogging.
FDA Notice on Emergency Response
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/fda-efforts-connect-manufacturers-and-health-care-entities-fda-department-veterans-affairs-national

3D Modeling/CAD Software
SolidWorks 2019
Model Origin
Custom illustration/CAD
Printer Make/Model
Universal Laser Systems VLS4.60
Print Units
mm
Printer-specific Build Instructions
Specific material
Pet- G film(face shield) (up to .016" thick), Polypropylene (Copoly) sheet (3/16" thck
Number of prints per build
4
Build time
7 minutes
Pre- and Postprocessing Instructions
The Polypropylene (Copoly) can have debris on the laser cut edge, make sure to scrape or sand before assembly. See attachments for more information.
Attribution Instructions
This design was produced by the Assistive Technology team at the Central Virginia VA Health Care System: Seth Hills, John Miller, and Brian Burkhardt under the leadership of Melissa Oliver.
https://www.richmond.va.gov/services/Assistive_Technology_at_McGuire_VA_Medical_Center.asp

Files

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TDP Category Type Filename Size
Assembly Instructions application/pdf Face Shield Assembly Instructions CVHCS.pdf 631.65 KB
General Instructions additional images.docx 36.73 KB
General Instructions application/pdf FaceShieldUs_VisorTemplate_v3.pdf 1.98 MB
General Instructions IFU_ Face Shield CVHCS.docx 437.52 KB
General Instructions QC_Face_Shield CVHCS.docx 785.12 KB
Native CAD CVHCS_FS_Frame V2.DXF 40.52 KB
Native CAD CVHCS_FS_Nose_Piece_H_V2.DXF 26.94 KB
Native CAD CVHCS_FS_Nose_Piece_Wishbone_V2.DXF 25.95 KB
Native CAD CVHCS_FS_Shield_V2.DXF 28.61 KB
STL File CVHCS_FS_Frame V2_0.STL 55.16 KB
Blender-generated-x3d CVHCS_FS_Frame V2_0.STL60c0b256231e3.x3d 35.03 KB
STL File CVHCS_FS_Nose_Piece_H_V2_0.STL 14.73 KB
STL File CVHCS_FS_Nose_Piece_Wishbone_V2_0.STL 20.00 KB
STL File FaceShieldUs_Headband_v3_0.stl 1.82 MB

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Part Information

Additional Owner's Names

jknotts

AMCPR Type

designPackage

Model Number

3DPX-013456

Review Process

simple

Public

Yes
2021-06-09T12:21:10

Materials

Polymer

General Build Material

PP

Exact Build Material

Polypropylene Filament

Quality Standards

Submission Path

production

Assembly Required

Yes
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