Maker Response Hub - Medical Facility Instructions
Thank you for your hard work on the front lines of the fight against COVID-19. Below are the instructions and information needed to succeed when assembling your donated 3D printed PPE.
Thank you for your hard work!
Please share your 3D printed face shields to social media to help spread the word that MatterHackers can help provide PPE to other hospitals and medical facilities in need. Be sure to tag #MakerResponseHub and tag @matterhackers so other professionals can find us. Keep up the great work!
Device Overview
This face shield consists of two (2) components: the Visor Frame (A.) (3D printed), the Clear Face Shield Component (B.) as seen in Figure 1. Components to be disinfected and reused for multiple uses by the same user as long as proper disinfectant protocol is followed and there is no visible damage to parts.
The Visor Frame will be in direct contact with the provider’s skin and is made of one of the following materials: PLA (Polylactic Acid) OR PETG (Polyethylene Terephthalate Glycol-modified) OR Nylon (Polyamide) OR ABS (Acrylonitrile butadiene styrene). None of the materials include any drugs or biologics.
Warnings
It is NOT recommended to use the face shield in the presence of high-intensity heat source or flammable gas for flammability concerns (product not tested against 16 CFR 1610).
Directions For Use
Step 1: Clean and Disinfect
Sanitize both the Clear Face Shield Component and 3D Printed Visor Frame. It is important that you DO NOT sterilize the components with heat treatment or soak for an extended period of time in cleaners.
All components should be inspected to ensure that there is no visible damage to parts.
Wipe down and disinfect all faces and features on Visor Frame and Clear Face Shield.
The following disinfection or cleaning agents for the recommended cleaning procedures of the face shield, listed in preferential order. Other disinfectants may work as well but have not been evaluated.
1. Super Sani-Cloth
2. 10% chlorine bleach solution (*May fog Clear Face Shield Component over time)
3. CaviWipes
4. Soap and water
Step 2: Assemble
To assemble your face shield, secure the holes on the Clear Face Shield Component to the correlating notches on the 3D Printed Visor Frame as demonstrated in Figure 1. The six holes on the Clear Face Shield Component and six notches on the 3D printed visor frame should align.
Disclaimer for Donated Items
MatterHackers will not provide refunds, or take returns for any donated products.
This product has not been FDA cleared or approved.
This product has been authorized by the U.S. Food and Drug Administration (FDA) under an Emergency Use Authorization (EUA) for use by healthcare providers as personal protective equipment (PPE). The FDA issued a EUA in response to concerns relating to insufficient supply and availability of face shields for use by health care personnel (HCP) as personal protective equipment in healthcare settings in accordance with CDC recommendations to cover the front and sides of the face and provide barrier protection during the Coronavirus Disease 2019 (COVID-19) pandemic.
This product is only authorized for the duration of the declaration that circumstances justifying the authorization of emergency use under Section 564(b)(1) of the Act, 21 USC 360bbb-3(b)(1) unless the authorization is terminated or revoked sooner.
Reporting Adverse Events
Report any adverse events to MatterHackers by including location, contact information, order number, and a thorough description of the adverse event. Contact by sending an email to community@matterhackers.com (subject line ‘PPE Adverse Event Reporting’) OR a letter to MatterHackers Inc. Attn: COVID19 Community, 20321 Valencia Cir, Lake Forest, CA 92630.
Version History
Version 1.2 (04/20/2020) - updated per FDA Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations
Request a Quote
To learn about available discounts, training, and maintenance options, please use the form below and a MatterHackers Expert will contact you within one business day. Alternatively, you can always feel free to give us a call at +1 (800) 613-4290 or email sales@matterhackers.com.