GE Community face mask frame
GE ADDITIVE COMMUNITY FACE MASK COLLECTION TECHNICAL DATA PACKAGE (TDP) PART NUMBER 4212AS0294-0-AM AND ALL LATER VERSIONS
The GE Additive Community Face Mask Collection is a GE Additive (OEM Part Number #MF001-P0M2) design provided under a CREATIVE COMMONS ATTRIBUTION 4.0 INTERNATIONAL PUBLIC LICENSE. The face mask design includes a plastic face mask frame in three sizes (S, M, L) that can be printed on non-industrial 3D printers; replaceable filter material that fits under the face mask frame; and elastic bands that wrap around the head to hold the face frame and filter material in place . Filter materials can be made from a variety of widely available materials and can be replaced or cleaned and re-used in accordance with user instructions.
GE Additive Community Face Mask Collection Label
IDENTIFICATION: PN4212AS0294-1-AM GE ADDITIVE FACE MASK COLLECTION
USEAGE: PROVIDED FOR COMMUNITY USE–NOT FOR MEDICAL USE/NOT FOR SURGICAL USE
MATERIALS: FACE FRAME (COMPOSITE POLYMER, 3D PRINTED OR LASER CUT), FILTER MATERIALS (CLOTH COTTON OR COTTON BLEND AND DISPOSABLE FILTER MEDIA AS LISTED IN TECHNICAL DATA PACKAGE), 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 BEFORE USE FOR OBSERVABLE CRACKS, CHIPS, OR OTHER DEFECTS. REPORT DEFECTS TO [email protected]
PRECAUTIONS: THIS ITEM IS INTENDED FOR REUSE PROVIDED THAT IT IS PROPERLY DISINFECTED BETWEEN EACH USE BY APPLYING CLEANSER FOR DISINFECTING PLASTIC PRODUCTS (E.G. CAVICIDE) AND WASHING OR REPLACING FILTER MATERIALS AND ELASTIC BANDS IN ACCORDANCE WITH USER INSTRUCTIONS. NON-CLOTH FILTER MATERIALS SHOULD NOT BE PLACED DIRECTLY IN CONTACT WITH SKIN. NON-CLOTH FILTER MATERIALS SHOULD NOT CONTAIN FIBERGLASS.
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 OR TO [email protected].
ASSEMBLY AND USE USER 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 AND [email protected]. 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 in the document below.
GE Additive Community Face Mask Collection Technical Data Package Content
- Background and guidance for Navy users of the TDP Design drawings with dimensions and tolerances
- Material recommendations including alternate materials for face frame and filter
- Manufacturing instructions including non-industrial 3D printers and alternative manufacturing instructions for 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 central email
- Shipping and packing templates for delivery of items to users
- User instructions for assembly and use
- User instructions for re-use and replacement of filter materials