Ford - with consulting support from 3M - has developed a unique powered-air purifying respirator (PAPR) for use in reducing exposure to airborne particles. This PAPR is designed to quickly aid healthcare workers during the COVID-19 pandemic by providing constant filtered airflow.
Doning and Doffing the Limited Use Healthcare PAPR
Purchase Information
The Ford Limited Use Public Health Emergency PAPR is being made available in connection with a U.S. Food and Drug Administration Emergency Use Authorization. It is for sale in the US through 3M authorized distributors. 3M and Ford will donate any profits they earn from the sale of these PAPRs to COVID-19 related nonprofit organizations.
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Product BrochureLearn more about the features and benefits of this limited use PAPR.
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Pricing Information
Spare parts and accessories available until June 30, 2021, or until supplies last.
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Technical Support
For technical support, please contact:
Technical Service
844-206-1444For technical support, please contact:
Technical Service
844-206-1444
Limited-Use Public Health Emergency Powered Air Purifying Respirator (PAPR) User Instructions
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Emergency PAPR Quick Start Guide -
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Full System User Instructions -
Shoulder Strap User Instructions
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Who can use the FORD PAPR system per the U.S. FDA Emergency Use Authorization?
From the FDA letter for the Emergency Use Authorization:
https://www.fda.gov/media/135763/download
Healthcare personnel refers to all paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. These healthcare personnel include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, physicians, technicians, therapists, phlebotomists, pharmacists, dentists and dental hygienists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel.
For more information, you can contact the FDA through the information provided on their website (http://www.fda.gov).
Frequently Asked Questions (FAQ) Limited-Use Public Health Emergency Powered Air Purifying Respirator (PAPR) System
PAPR System Basics
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What is a Powered Air Purifying Respirator (PAPR) system?
A PAPR system is a piece of respiratory protection equipment that consists of a battery-powered blower unit, filter, breathing tube and an air delivery unit (half facepiece, full facepiece, loose fitting hood, full hood or helmet). The PAPR system pulls potentially contaminated air into the blower unit via a fan and filters the air through a high efficiency particulate air (HEPA) filter or other filter media. Then it pushes the filtered air through a breathing tube up to a facepiece or head covering.
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What respiratory protection is recommended for bioaerosols like SARS-CoV-2, the virus that causes COVID-19?
In the healthcare setting, the U.S. Centers for Disease Control and Prevention (CDC) recommends a respirator that has been tested and certified by the U.S. National Institute for Occupational Safety and Health (NIOSH) and, when appropriate based on the procedures being performed, cleared by the FDA for health care workers. A PAPR system with a loose fitting hoodtop can be a good option for those with beards or who are unable to pass a respirator fit test. NOTE: The CDC has not specified any safe levels of exposure to biological particles. This respirator can help reduce inhalation exposures to certain airborne biological particles (e.g. viruses, mold, Bacillus anthracis, Mycobacterium tuberculosis, SARS-CoV-2, etc.) but cannot eliminate exposure or the risk of contracting infection, illness or disease. The U.S. Occupational and Safety Health Administration (OSHA) and other government agencies have not established safe exposure limits for these contaminants.
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What particle size will the HEPA filter remove?
HEPA filters are tested against a particle size of approximately 0.3 microns mass median aerodynamic diameter (MMAD) by the U.S. National Institute for Occupational Safety and Health (NIOSH). This particle size is in the range of sizes most difficult to capture and the HEPA filter must maintain a minimum of 99.97% filtration efficiency. NIOSH tests particulate respirators under “worst case” laboratory conditions to help ensure anticipated performance in the workplace.
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What is the usable life of this PAPR system?
This device has been approved by NIOSH in accordance with its Limited-Use Public Health Emergency PAPR guidance issued in April of 2020 and adheres to FDA’s March 28, 2020 letter authorizing emergency use of NIOSH-approved PAPRs. Use of this device is authorized only until the declaration that circumstances exist justifying the authorization of the emergency use of personal respiratory protective devices during the COVID-19 outbreak is terminated under Section 564(b)(2) of the Federal Food, Drug, and Cosmetic (FD&C) Act, or until the Emergency Use Authorization is revoked under Section 564(g) of the Federal FD&C Act, or until the approved configuration can no longer be maintained, whichever is shorter.
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Does using a PAPR system require a medical evaluation before use?
Yes. The use of a PAPR system does require a medical evaluation according to the OSHA Respirator Protection Standard 29 CFR 1910.134 before use to determine if the individual using the PAPR system is physically capable of use and that use of the PAPR system will not cause them any undue harm.
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Does using a PAPR system require training?
Yes. The use of all respiratory protection equipment (per the OSHA Respiratory Protection Standard 29 CFR 1910.134) requires end user training before use and at least yearly after that.
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Does using this PAPR system require fit testing.
No. Loose fitting hoodtops do not require end user fit testing.
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Can a person with a beard wear the hoodtop?
Yes, as long as the beard does not interfere with the sealing surface (the elastic that meets the face) of the hoodtop and the face.
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What is the assigned protection factor (APF) of this PAPR system?
When properly donned and used according to the User Instructions, this PAPR system has been tested and approved by NIOSH as a loose fitting hoodtop and has an APF of 25.
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Why does the hood have an Assigned Protection Factor (APF) of 25 and not 1000?
NIOSH states that any type of loose fitting head top (partial hood, full hood, helmet) is only approved to and APF of 25, unless the company asking for the approval also performs extra testing to show it can protect up to 1000 APF. The additional testing to obtain an APF of 1000 was not done for this system.
PAPR System Use
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How do I check the air flow of the PAPR system to make sure it is blowing enough air?
Push the end of the air flow indicator (AFI) with the black rubber gasket into the top of the blower unit until is seats tightly. Rotating the AFI while inserting may improve insertion effort. Make sure that it is tightly seated in the blower unit. Start the blower unit by pushing the power button on the bottom of the blower unit and let the system stabilize for 1-minute. Hold the blower at a slight angle so the AFI is straight up-and-down. The floating ball in the AFI must be above the line indicating minimum air flow. If it does not float above the line, do not use the PAPR system. See the User Instructions for more information.
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What steps should I take prior to using the PAPR system?
Before each use, the PAPR system must be equipped with a fully charged battery and pass a visual and functional (using the AFI) inspection. See the User Instructions for more information regarding pre-use inspection of the PAPR system. If the PAPR system does not pass any part of the inspection, do not use the PAPR system and remove it from service.
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Does the hoodtop come pre-adjusted from the factory?
No. There is an over the top of the head crown adjustment and, an around the head adjustment that must be fitted by and to the individual that will wear the hoodtop.
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Does the hoodtop have an exhalation valve?
No. High volume (>170 liters/min) filtered air is forced into the hoodtop to maintain positive pressure. The excess air is allowed to escape past the elastic that surrounds the head and keeps the hoodtop in place.
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How do I know what hoodtop size to select and what are the sizing guidelines for the Ford hoodtops
This PAPR Kit contains one medium/large hoodtop. Small/medium and Additional Med/Large hoodtops are available for purchase. This chart explains head sizing. Order information and part numbers are available on this document (PDF, 50.26 KB).
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What hoodtops are compatible with the PAPR system?
Currently, S/M (small/medium) and M/L (medium/large) hoodtops are available. See the User Instructions for part numbers and Appendix A of the User Instructions for a sizing chart.
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What is the PAPR blower unit run time associated with the battery? And how long does it take to charge the PAPR system battery?
Ford PAPRs with new, fully charged batteries can have run times exceeding 8 hours (3Ah battery) and 14 hours (5Ah battery).
Charging Times:
DeWALT® DCB230, 3Ah battery = 1.5 hours
DeWALT® DCB205, 5Ah battery = 2.5 hours
*Actual PAPR system battery charging time may be extended or shortened depending on battery age and environment. -
What type of batteries and charger are needed for this PAPR system and how can I get replacements?
This PAPR system uses DeWalt batteries and charger. Both the DeWALT DCB230 3-Amp.hour and DCB205 5-Amp.hour batteries are standard off the shelf batteries. They are the only batteries that are NIOSH approved with this system, as well as the 2 Amp battery charger DeWALT CDB112. These products may be purchased at locations that sell DeWALT parts.
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What altitude can I use my Ford PAPR at?
Data indicates that the Ford PAPR is capable of operating at altitudes up to 10,000 feet elevation. Please check airflow with Air Flow Indicator per User Instructions to ensure the minimum flow rate is met. If the bottom of the Air Flow Indicator ball fails to rise at or above the minimum flow level, do not use the blower unit.
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How do I change out the battery pack for the PAPR system?
To assist with removing the battery pack, lay the blower unit on its back, with the battery door facing you. Click the latching tabs one at a time to release the battery compartment door and expose the battery compartment. See the User Instructions for more information.
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What are typical run times?
Ford PAPRs with new, fully charged batteries can have run times exceeding 8 hours (3Ah battery) and 14 hours (5Ah battery).
PAPR System Issues
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My face is touching the visor of the hoodtop. What can I do?
The hoodtop has an integrated suspension. Check that you have the appropriate size and ensure the hoodtop has been properly donned and adjusted. The headband of the suspension should be worn around your forehead and the crown strap should be positioned on top of the head (not around the back of the head). Adjust the crown strap for wearing comfort and stability.
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Is there an alternate method of carrying the PAPR system to help prevent fatigue?
The main carrying apparatus for the PAPR system is the waist belt. There is however a Shoulder Harness Accessory (Part Number USA1-60240) that may also be used (in combination with the main belt) to redistribute some of the PAPR system weight over the right or left shoulder. See the User Instructions that accompany the Shoulder Harness Accessory for installation instructions.
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Can the air filter be changed if it becomes clogged?
No. The HEPA filter is not end user changeable. If the filter becomes clogged or damaged, the PAPR unit should be removed from service.
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About how much run time is left for the PAPR system when the low battery alarm sounds?
When the low battery alarm sounds there is approximately 10 to 15 minutes of blower time remaining in the battery for the PAPR system. When the alarm sounds, exit the hazardous area immediately.
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How much noise does the system generate?
The noise measured at the end user’s ear is less than 80 dB(A).
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Does this product contain any natural rubber latex?
No.
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What will determine the out of service /change out schedule and status for the PAPR units?
If the system, when equipped with a full charged battery, will not maintain proper air flow, the system needs to be taken out of service. There is no Ford set change out schedule for the PAPR HEPA filter as the filter is integrated into the blower unit. A change out schedule may be designated by your organizations infection control policy. In addition, when the relevant U.S. FDA Emergency Use Authorization (EUA) expires or is canceled, the PAPR systems are no longer NIOSH approved for use and should be taken out of service.
PAPR System Repair, Cleaning, Disinfection and Disposal
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Are replacement parts available for my PAPR system?
Yes, there are replacement parts available for the PAPR system. See the ‘LISTING OF COMPONENTS AND ACCESSORIES’ section in the User Instructions.
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Where can I find information if I need replacement parts or am having issues with my PAPR system?
Please call Technical Service at 1-844-206-1444.
Please call Technical Service at 1-844-206-1444.
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How do I clean and disinfect my PAPR system?
See the User Instructions and Appendix A of the User Instructions for cleaning and disinfecting procedures for the PAPR blower, belt, breathing tube and hoodtop.
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What type of warranty is available for this PAPR system?
The PAPR system and its component parts are warrantied against defective materials and workmanship at the time of purchase. The PAPR blower unit (excluding accessories and consumables) is warrantied for 90-days from the date of purchase or the end of the applicable FDA Emergency Use Authorization (EUA), whichever comes first. Contact DeWALT® for information regarding the batteries or charger. See the User Instructions for the warranty.
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Will Ford take back unused PAPR systems or dispose of used PAPR systems after the end of the applicable FDA Emergency Use Authorization (EUA)?
At this time, Ford will not be repurposing or collecting unused or used PAPR systems. Please see the User Instructions for proper disposal of the PAPR system, batteries and other components.
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What is the expiration date of the PAPR system?
The expiration date of the Ford Limited-Use Public Health Emergency PAPR is October 1, 2024. It should be removed from service before that date if either of the following occur:
- You can no longer maintain the approved configuration for your Ford Limited-Use Public Health Emergency PAPR. This means that you no longer have a complete set of undamaged, fully functional PAPR parts, and replacement parts cannot be obtained.
- The declaration that circumstances exist justifying the authorization of the emergency use of personal respiratory protective devices during the COVID-19 outbreak is terminated under Section 564(b)(2) of the Federal Food, Drug, and Cosmetics Act, or the EUA is revoked under Section 564(g) of the Federal Food, Drug, and Cosmetics Act.
If the PAPR is removed from service under item (2) above, it may be stored until October 1, 2024 in contemplation of future public health emergencies, but it may not be placed back into service without an applicable public health emergency declaration and emergency use authorization. Note that if the PAPR is stored during its useful life, proper storage of the PAPR and battery packs in accordance with the User Instructions is important to maintaining proper functionality.
Once the expiration date has been reached, you should dispose of your Ford Limited-Use Public Health Emergency PAPR. Please see the User Instructions for proper disposal of the PAPR system, batteries and other components.
Additional Resources
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Report a ConcernUse the link above to report potential fraud to us or call the fraud hotline at 1 (800) 426-8688.
Use the link above to report potential fraud to us or call the fraud hotline at 1 (800) 426-8688.
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