Description

3DVERKSTAN PROTECTIVE FACE SHIELD TECHNICAL DATA PACKAGE (TDP) PART NUMBER 4212AS0 301 -0-AM AND ALL FUTURE REVISIONS PART NUMBER 4212AS0 302 -0-AM AND ALL FUTURE REVISIONS Overview: The 3DVERKSTAN PROTECTIVE FACE SHIELD is a 3D Verkstan design provided under a CREATIVE COMMONS ATTRIBUTION 4.0 INTERNATIONAL PUBLIC LICENSE. The face shield design includes a headband that can be printed on non-industrial 3D printers or laser cut using a laser cutter ; a faceplate made from clear acetate office sheets; and attached elastic bands that wrap around the head to hold the face shield in place. VERKSTAN3D Protective Face Shield Label IDENTIFICATION: PN4212AS0 301 -0-AM ASSEMBLY, PN4212AS0 302 -0-AM HEADBAND USEAGE: PROVIDED FOR COMMUNITY USE–NOT FOR MEDICAL USE/NOT FOR SURGICAL USE MATERIALS: COMPOSITE POLYMER, 3D PRINTED , WATERJET OR LASER CUT, ACETATE 8.5 INCH X 11 INCH SHEET, ELASTIC BANDS <ELASTIC BANDS MAY CONTAIN LATEX> WARNINGS: THIS ITEM WILL NOT CAUSE FLAMMABILITY BUT DO NOT USE THIS DEVICE NEAR SOURCES OF HIGH TEMPERATURES OR FLAME. INSPECT FACE SHIELD BEFORE FOR OBSERVABLE CRACKS, CHIPS, OR OTHER DEFECTS. REPORT DEFECTS TO [email protected] PRECAUTIONS: THIS FACE SHIELD IS INTENDED FOR REUSE PROVIDED THAT IT IS PROPERLY DISINFECTED BETWEEN EACH USE BY APPLYING CLEANSER FOR DISINFECTING PLASTIC PRODUCTS (E.G. CAVICIDE) ADVERSE REACTIONS: EXTENDED USE OF THIS ITEM MAY CAUSE DISCOMFORT OR IRRITATION OF THE SKIN. THIS DEVICE HAS NOT BEEN CLINICALLY TESTED PLEASE REPORT ADVERSE REACTIONS TO THE MANUFACTURER AT [email protected]. ASSEMBLY AND USE INSTRUCTIONS: ARE INCLUDED IN THE TECHNICAL DATA PACKAGE FOR THIS ITEM DISCLAIMER THIS DEVICE HAS NOT BEEN EVALUATED BY FDA FOR ITS SAFETY OR EFFICACY. USERS SHALL USE THIS DEVICE IN ACCORDANCE WITH THE DIRECTIONS OF USE AND AGREE TO REPORT ANY MATERIAL DEFECTS AFFECTING THE SAFE AND EFFECTIVE USE OF THIS DEVICE TO THE MANUFACTURER. THE MANUFACTURER WILL UPDATE THE LABELING TO REFLECT ANY CONCERNS RAISED IN THOSE REPORTS How to use a 3D Technical Data Package (TDP): All 3D TDPs are PDF files and must be downloaded and opened with a PDF reader program. Opening the TDP using a viewer – e.g. double clicking the file from a web browser – will not allow access to the full content of the TDP. Detailed instructions are available here in this record. 3D VERKSTAN Protective Face S hield Technical Data Package Content Background and guidance for Navy users of the TDP and full instructions for using the TDP and howto access all content-License and disclaimer Design drawings with dimensions and tolerances Material recommendations including alternate material s Manufacturing instructions including non-industrial 3D printers and alternative manufacturing instructions for waterjets and laser cutters Kitting instructions and material recommendations for kitting Labeling instructions for non-regulated community personal protective equipment Manufacturing record log templates for manufacturing sites to maintain locally and send to centralemail Shipping and packing templates for delivery of items to users-User instructions for assembly and use