Materials

This product is designed to reduce exposure to various harmful airborne particles but does not eliminate the risk of exposure to or contraction of any disease or infection. Improper use may result in sickness or death. Ensure proper use.

Intended Use

Following CDC guidance, this respirator is intended to be used by healthcare workers for the duration of the Health Care Emergency and is authorized for use in healthcare setting under the Emergency Use Authorization by the FDA. This device meets CDC guidance for M.Tuberculosis exposure control. When worn properly, this respirator is intended to reduce user exposure to various airborne particles.

Instructions for Use

1. Consult federal, state and government agency regulations to ensure proper respirator use in the workplace. In the United States, employers must adhere to U.S. OSHA 29 CFR 1910.134 which includes a medical evaluation, training, andfit testing prior to respirator use in occupational settings. These user instructions are not a substitute for a written respirator training program which meets the aforementioned requirements. Fit testing must be performed on an individual basis, and a respirator should be selected to meet all the requirements for use, including compatibility with any other clothing or equipment which may interfere with fit. Fit testing should be performed at minimum annually by the employer using OSHA accepted protocols. Each time a respirator is worn, a fit assessment should be made by the user. This device is not intended to be used by those without proper training.
2. Thoroughly inspect the respirator mask prior to use. If components, including the filter material, the two headbands, the nose clip, or the headband attachments, are damaged or missing, do not use and dispose of properly. Damage may include missing components, tears or holes in the filter material, or other issues which noticeably have a negative effect on performance.
3. Immediately leave the contaminated area and seek help if dizziness, difficulty breathing, or other deleterious conditions arise.
4. This is a single use respirator. It may be used until it becomes difficult to breathe through, damaged, or is thought to be contaminated in any way. In a healthcare setting, it should be discarded after each examination or procedure. Given the Public Health Emergency PPE shortage, follow current government and facility guidance and regulations.
5. This product is not for use with beards, other facial hair or conditions which do not allow a proper seal between the respirator and the face. A fit check should be performed before every use. If a proper seal cannot be achieved, do not use.
6. Given current CDC guidance, it is recommended that this product is not for use by the general public in order to ensure supply for healthcare workers.

Fitting Instructions

1. Hold the respirator in your hand, with nose wire upward and headbands hanging below hand.
2. Place bottom of mask under chin, nose wire upward, and position over nose and mouth. Pull the upper strap to the top, back of head.
3. Pull the lower strap overhead to back of neck, secure below ears. Ensure that nothing is interrupting the seal between the respirator and the face.
4. With both hands cupped over the mask, press the nose wire with your fingertips to conform to the bridge of the nose. Ensure that the nose wire does not have a sharp bend not touching the nose, as this will result in an improper seal.
5. Complete a user seal check. Cover the mask with both hands and breathe sharply. If leakage is detected along the edge of the mask or nose wire, adjust nose wire, straps or repeat the above steps and perform another seal check. If leakage cannot be eliminated, do not enter hazardous environments and seek proper replacement protection.

Removal Instructions

1. Without touching the respirator filter media, remove the bottom strap from back head. Lift the top strap off form back, top of head. Be mindful not to touch face or respirator filter as hands may be contaminated. Dispose or store in accordance with current government and facility guidance and regulations.