팝업레이어 알림

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Instructions for Use (SG9010V)

IMPORTANT: Keep these user instructions for reference.

Use this product for

  • Intended for use in healthcare settings by HCP when used in accordance with CDC recommendations to prevent wearer exposure to pathogenic biological airborne particulates during FFR shortages resulting from the COVID-19 outbreak.

  • Before use, the wearer must read and understand these user instructions. Misuse can result in sickness or death. For proper use, review these user instructions or contact jongbinkim@enwusa.com OR +1 443 538 2571.

Do not use

  • Do not use if a product is damaged in any way, or if you cannot achieve a proper seal after following the fitting instructions below. Inspect the product before each use.

  • Stop use and move to an area with clean air immediately if breathing becomes difficult, or upon experiencing dizziness or other distressing situations or symptoms

  • Failure to follow all instructions may result in reduced effectiveness and/or may pose temporary or permanent harm or risks to the user.

  • Do not use for gases, sandblasting, oil aerosols, or for protection against organic vapors above the occupational exposure limit for these substances; particulate concentrations that exceed either 10 times the occupational exposure limit or applicable government regulations, whichever is lower. Not for use in oil mist atmospheres. This respirator does not supply oxygen. Do not use in atmospheres containing less than 19.5% oxygen.

  • Do not reuse the product once used. After using, dispose the respirator.

Use Limitations

  1. 1. The wearer must first be trained in the proper use and fit, and be tested before using this respirator.
  2. 2. Do not use this respirator when levels or concentrations of contaminants are immediately dangerous to life or health.
  3. 3. Leave the contaminated area immediately if breathing becomes difficult, or dizziness or other distress occurs
  4. 4. Discard and replace respirator if it becomes damaged or breathing resistance becomes excessive.
  5. 5. Inspect respirator before use to ensure it is in good working condition. Examine all the respirator parts for signs of damage including the two straps and noseclip.
  6. 6. Do not alter, wash, abuse or misuse this respirator.
  7. 7. Do not use with beards or other facial hair or other conditions that prevent a good seal between the face and the sealing edge of the respirator.
  8. 8. Should not be used beyond or over the limits specified by any applicable government regulations for this product.
  9. 9. Failure to follow all instructions and warnings on the use of this respirator and/or failure to wear this respirator during all times of exposure can reduce respirator effectiveness and may result in illness or permanent disability.
  10. 10. Make sure the respirator is not crushed or squeezed by an outside force, as this may result in the deformation and damage of the respirator. Especially pay more attention when the wearer is biking, running or conducting other activities.
  11. 11. Outside forces acting upon the noseclip on the respirator may result in injury to the wearer.
  12. 12. The product is not FDA-cleared or approved and is only authorized under an EUA and is authorized only for the duration of emergency circumstances.

Storage information

  • Store respirators in the original packaging, away from contaminated areas, dust, sunlight, extreme temperatures, excessive moisture, and damaging chemicals.
  • Shelf life of unopened product is 3 years from date of manufacture specified on packaging as expiration date when stored within temperature range of -20°C to +30°C and at less than 80% relative humidity.

Fitting instructions

  • a) Cover the front of the respirator with both hands, being careful not to disturb the position of the respirator.
  • b) Exhale sharply. If air leaks around the nose bridge, readjust the nosepiece as described in figure 4. If air leaks at the respirator edges, work the straps back along the side of your hand. If you CANNOT achieve a proper seal, DO NOT enter the contaminated area. See your supervisor.
  • c) If no leakage is detected, then work may proceed.

It is very important to press the nosepiece firmly
to the nose bridge to form a good seal.
For more information, or if you experience any ADVERSE EVENT,
please contact us immediately at:

  • Phone: +1 443 538 2571

  • Email: mobae@enwglobal.com

  • Address: #129, Bogaesan-ro, Bogae-myeon, Anseong-si, Gyeonggi-do 17508, Republic of Korea