DtM-v3.1 Face Shield PPE, 3D printable headband NO LOGO

Model Description

*This model sourced with permission from the NIH 3D Print Exchange*Model ID 3DPX-013359Category Labware & DevicesDevice Use Safety and Personal Protective EquipmentKeyword(s) PPE, 3D Printed Face Shield, face-shield, Face shield PPE, Face Shield for 3D PrintingThe following refers to: 3DPX-013359The 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.This is an update of "DtM-v3.0 Face Shield PPE, 3D printable headband", item 3DPX-013238. We have removed the logo from the STL and CAD file, in order to improve cleanability and infection control. Product Point of ViewHealthcare 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 glassesBill of Materials• 3d-printed headband in PLA, roughly 50g/1.75oz per part. Outer envelope of 3d-printed headband is 191mm wide, 148.5mm long, and 52.5mm tall. Print time is roughly 3h15m per part on a Prusa i3 MK2S and a Lulzbot Taz 6 at 30% infill, no supports.o Acceptable alternate 3d printing materials include PETG, ABS, ASA, Nylon• Elastic for the headband: could be 7”x1/8” rubber bands, 13” strip of 3/4" wide buttonhole elastic, coflex/coban tape• A standard US letter-sized transparency or report-cover for the shield, 2-10mil (0.002-0.01”, 0.05-0.25mm) thicknesso Acceptable alternative materials include clear PETG, PMMA or mylar in the same thicknesses cut to 8.5” x 11” (215.9mm x 279.4mm). Dimensions for a US-style three-hole-binder punch: three 6-8mm diameter holes with each center spaced 108mm apart. Do NOT laser-cut PVC• Options:o Clinicians and caregivers who have worn the device on service recommend the following additions to the headband to improve comfort: add a wrap of foam tape or "chest tube foam tape", tape layers of gauze or a folded paper towel on the headband; dispose as necessaryo Before hole-punching, add tape (duct tape, medical cloth tape, etc) to reinforce the holes at top of the transparency sheet during repeat use and washings. Remove and replace tape between patients as necessary.Instructions for Use and Assembly1. Punch holes in standard US letter-sized transparency (8.5x11 in) with a standard US three-hole-punch.2. Attach transparency to headband on the three mounting pegs.3. Attach elastic to headband with cleats near temples, adjust to fit. Some users may find 7” rubber band too tight, consider chaining elastic bands as necessary.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. This design is a remix from the Prusa Protective Face Shield - RC2. We are grateful to the team at Prusa for their design skills, their commitment to open hardware, and their leadership in a crisis.FDA Notice on Emergency Responsehttps://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 For Fusion CAD files, see the PrusaPrints archive here:https://www.prusaprinters.org/prints/27748-dtm-v30-face-shield-ppe-for-covid-19-remix-of-prus/files3D Modeling/CAD Software Autodesk Fusion 360Model Origin Custom illustration/CADPrinter-specific Build Instructions Specific material PLABuild time 2hr 48 minPre- and Postprocessing Instructions We recommend printing in PLA with the following settings:• Nozzle Diameter: 0.4mm• Programmed Extrusion Width: 0.5mm• Layer Height: 0.3mm• Shells: 3 (which results in a 1.5mm wall)• Infill: 30%• Infill Type: Grid• Solid Bottom Layers: 3 (which results in a 0.9mm thick bottom)• Solid Top Layers: 3 (which results in a 0.9mm thick top)Acceptable alternate 3d printing materials include PETG, ABS, ASA, Nylon. We don't have any information on chemical resistance of HIPS, and we don't recommend this material at this time until the team can conduct further investigation and testing.Attribution Instructions For a full list of over 40 contributors, see here:https://www.designthatmatters.org/covid-19Reviewer Notes The following refers to: 3DPX-013359The 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.

Files

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TDP Category Type Filename Size
General Instructions additional images_0.docx 55.96 KB
General Instructions DtM facechield_0.docx 19.72 KB
General Instructions application/pdf IFU_Face_Shield _Rev.1.1_03_30.20_0_0.pdf 5.47 MB
General Instructions application/pdf QC_Face_Shield_Rev.1.0_03.30.20_0_0.pdf 1.42 MB
STEP File DtM-v3.0_0.step 346.78 KB
STEP File DtM-v3-A4_0.step 326.94 KB
STL File DtM-v3_0_0.stl 920.10 KB
Blender-generated-x3d DtM-v3_0_0.stl60c0c4bf67aa7.x3d 615.18 KB

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Part Information

Additional Owner's Names

jknotts

AMCPR Type

designPackage

Model Number

3DPX-013359

Review Process

simple

Public

Yes
2021-06-09T13:39:43

Materials

Polymer

General Build Material

PLA

AM Process

Material Extrusion

Quality Standards

Submission Path

production

Assembly Required

No
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