N95 Flat Fold Respirator | Model 283036

User Instructions

IMPORTANT:

Prior to use, read these user instructions and keep with package for future reference.

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.

Description:

This single use, non-powered air-purifying particulate respirator has a filtration efficiency of at least 95% of 0.3 micron airborne particulates free of oil. This product meets requirements of U.S. 42 CFR 84, and has been approved by NIOSH to provide N95 level of protection. This device does not protect against vapors or gasses. This device contains no components made with natural rubber latex.

Description:

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, and fit 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: Perform with every use

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. 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.
3. 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.
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.

Removal Instructions:

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.

Storage conditions:

Prior to use, this product should be stored in the original packaging in a clean area free of chemicals, moisture or extreme temperatures. When stored in manufacturer packaging in an location between -4°F (-20°C) to +85°F (+30°C) and not exceeding 80% relative humidity, the respirator may be used until the date labeled “EXPIRY” on the bottom of the packaging. On the bottom of the packaging “MFG” represents the date of manufacture; “EXPIRY” represents the expiration date; “LOT” represents the production lot of this product.

Filtering Facepiece Respirator for Public Health Emergency

THIS RESPIRATOR IS ONLY APPROVED IN THE FOLLOWING CONFIGURATION:

1. PROTECTION

N95 - Particulate Filtration (95% filter efficiency level) Effective against particulate aerosols free of oil; time use restrictions may apply.

1. CAUTIONS and LIMITATIONS

A Not for use in atmospheres containing less than 19.5 percent oxygen.

B Not for use in atmospheres immediately dangerous to life or health.

C Do not exceed maximum use concentrations established by regulatory standards.

J Failure to properly use and maintain this product could result in injury or death.

L Follow the manufacturer’s User Instructions for changing cartridges, canister and/or filters.

M All approved respirators shall be selected, fitted, used, and maintained in accordance with MSHA, OSHA, and other applicable regulations.

N Never substitute, modify, add, or omit parts. Use only exact replacement parts in the configuration as specified by the manufacturer.

O Refer to User Instructions, and/or maintenance manuals for information on use and maintenance of these respirators.

P NIOSH does not evaluate respirators for use as surgical masks.

PH The limited FFR approval will be effective 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 Act, or the EUA is revoked under Section 564(g) of the Act, or until such time that the approved configuration can no longer be maintained.