DemeTECH DemeMASK N95

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Tested against 0.3-micron particle (count median diameter) per 42 CFR 84

DemeMASK N95 Particulate Respirator

DT-N95-FH/DT-N95-FHS

This respirator helps protect against certain particulate contaminants but does not eliminate exposure to or the risk

of contracting any disease or infection. Misuse may result in sickness or death. For proper use, see supervisor,

or User Instructions

IMPORTANT

Before use, the wearer must read and understand these User Instructions. Keep these instructions for reference.

DESCRIPTION

The DemeTECH N95 Particulate Respirator is designed to help provide respiratory protection for the wearer. This

product has a filter efficiency level of 95% or greater against particulate aerosols free of oil

. It is fluid resistant and

disposable. It can fit a wide range of face sizes. This product contains no components made from natural rubber

latex.

INTENDED USE

It is intended to reduce wearer exposure to certain airborne particles in a size range of 0.1 to >10.0 microns.

CONTRAINDICATIONS

Not for use with beards or other facial hair that prevents direct contact between the face and the sealing surface

of the respirator. OSHA has not set a permissible exposure level for airborne biohazards.

USER INSTRUCTIONS

Before occupational use of this respirator, a written respiratory protection program must be implemented

meeting all the local government requirements. In the United States, employers must comply with OSHA 29

CFR 1910.134 which includes medical evaluation, training, and fit testing.

Respirator may be used until damaged, breathing becomes difficult, or contaminated. Otherwise, it may be

stored and reused according to the facility’s infection control policy.

Filtering facepieces are to be inspected prior to each use to good operating condition. Examine all the

respirator parts for signs of damage including the two headbands, nose foam, nose clip and facepiece

material. The respirator should be disposed of immediately upon observation of damaged or missing parts.

Immediately replace respirator if damaged.

Discard after every use. Follow national, state, local, and facility infection control guidance and policies.

Fitting Instructions (Must be followed each time respirator is worn)

Fig. 1 Fig. 2 Fig. 3 Fig. 4

1. Cup the respirator in your hand, with the nosepiece at your fingertips, allowing the headbands to hang freely

below your hand.

2. Position the respirator under your chin with the nosepiece up. Pull the top strap over your head resting it high

at the top back of your head. Pull the bottom strap over your head and position it around the neck below the

ears.

3. Place your fingertips from both hands at the top of the metal nosepiece. Using two hands, mold the nose area

to the shape of your nose by pushing inward while moving your fingertips down both sides of the nosepiece.

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Summary

Important Safety and Usage Information

Product Description and Intended Use

Contraindications for Respirator Use

User Instructions and Fitting

Fitting Instructions

Step-by-step guide on how to properly fit the DemeMASK N95 respirator to ensure an effective seal.

Respirator Removal and Approval Details

The DemeTECH N95 Particulate Respirator, identified by models DT-N95-FH and DT-N95-FHS, is a disposable respiratory protection device designed to help reduce the wearer's exposure to certain airborne particulate contaminants. Its primary function is to filter out particles from the air, thereby offering a level of protection against various aerosols. This respirator is intended for occupational use and is designed to be effective against particulate aerosols that are free of oil. It is important to note that while it helps protect against particulate contaminants, it does not eliminate exposure to or the risk of contracting any disease or infection. Misuse of the respirator can lead to serious health consequences, including sickness or death. Therefore, adherence to proper usage instructions and guidelines is crucial.

Function Description

The core function of the DemeTECH N95 Particulate Respirator is to provide respiratory protection by filtering airborne particles. It is designed to achieve a filter efficiency level of 95% or greater against particulate aerosols. This means that when properly worn, it is capable of filtering out at least 95% of airborne particles. The respirator is specifically intended to reduce wearer exposure to airborne particles ranging in size from 0.1 to greater than 10.0 microns. This makes it suitable for environments where such particulate matter is present. The design is fluid resistant, adding another layer of protection in certain occupational settings. It is also disposable, meaning it is intended for single or limited use before being discarded. A key feature of its construction is that it contains no components made from natural rubber latex, which is beneficial for individuals with latex allergies.

Usage Features

Proper usage of the DemeTECH N95 Particulate Respirator is paramount for its effectiveness. Before any occupational use, a written respiratory protection program must be implemented, adhering to all local government requirements. In the United States, this includes compliance with OSHA 29 CFR 1910.134, which mandates medical evaluation, training, and fit testing for users. The respirator is designed to fit a wide range of face sizes, but a proper seal is critical.

The fitting instructions emphasize a multi-step process to ensure an effective seal. First, the user cups the respirator in their hand with the nosepiece at their fingertips, allowing the headbands to hang freely. The respirator is then positioned under the chin with the nosepiece up. The top strap is pulled over the head and rested high at the top back of the head, while the bottom strap is positioned around the neck below the ears. A crucial step involves molding the metal nosepiece to the shape of the user's nose using fingertips from both hands, pushing inward and moving down both sides of the nosepiece. It is explicitly stated that pinching the nosepiece with one hand may result in improper fit and less effective performance, underscoring the importance of using two hands for this step.

After fitting, a User Seal Check must be performed prior to each wearing. This involves placing both hands completely over the respirator and exhaling. The user must be careful not to disturb the respirator's position during this check. If air leaks around the nose, the nosepiece needs to be readjusted. If air leaks at the respirator edges, the straps should be worked back along the sides of the head. If a proper seal cannot be achieved, the user must consult their supervisor. This seal check is a critical safety feature, ensuring the respirator functions as intended.

The respirator is approved for use in specific configurations, identified by the models DT-N95-FH and DT-N95-FHS, under the TC-84A-9251 approval number. It is important to only use the respirator in its approved configuration.

Maintenance Features

While the DemeTECH N95 Particulate Respirator is primarily a disposable device, there are specific guidelines regarding its inspection and when it should be discarded or reused. Filtering facepieces must be inspected prior to each use to ensure they are in good operating condition. Users should examine all parts of the respirator for signs of damage, including the two headbands, nose foam, nose clip, and the facepiece material itself. Any observation of damaged or missing parts necessitates immediate disposal of the respirator. If the respirator is damaged, it must be replaced immediately.

The respirator may be used until it becomes damaged, breathing becomes difficult, or it becomes contaminated. Otherwise, it may be stored and reused according to the facility's infection control policy. This indicates that while it is disposable, some facilities may have policies allowing for limited reuse under specific conditions, provided the respirator remains in good condition and is not contaminated. However, a general recommendation is to discard the respirator after every use, following national, state, local, and facility infection control guidance and policies. This emphasizes the importance of local protocols in determining the lifespan of the device in practice.

Removal instructions are also provided to ensure the respirator is taken off correctly without compromising its integrity or the user's safety. The user should cup the respirator in their hand to maintain its position on the face. The bottom strap is pulled over the head first, followed by the top strap, while still holding the respirator in position, before finally removing it.

It is crucial that users never substitute, modify, add, or omit parts of the respirator. Only exact replacement parts, if applicable, should be used in the configuration specified by the manufacturer. This reinforces the importance of maintaining the device's original design and integrity for optimal performance and safety. Users are also advised to refer to User Instructions and/or maintenance manuals for information on the use and maintenance of these respirators.

The respirator is not intended for use in atmospheres containing less than 19.5% oxygen or in atmospheres immediately dangerous to life or health. Users must not exceed maximum use concentrations established by regulatory standards. Failure to properly use and maintain this product could result in injury or death. All approved respirators must be selected, fitted, used, and maintained in accordance with MSHA, OSHA, and other applicable regulations. NIOSH does not evaluate respirators for use as surgical masks, clarifying its specific intended purpose as a particulate respirator.