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RESPIRATOR FFP2/N95 + IIR, unvalved, cup-shaped M

https://unicat.msf.org/cat/product/76928
STD ELINMASP05M

Valid Article

Single use
A single-use device, also referred to as a disposable device, is intended for use on one patient during a single procedure. It is not intended to be reprocessed (i.e., cleaned and disinfected or sterilized).
CE marking: declaration that the product meets EU standards for health, safety, and environmental protection. The CE marking indicates that the product may be sold freely in any part of the European Economic Area, regardless of its country of origin.
T020604 - Medical use face masks, type ii and iir
European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. EMDN is characterised by its alphanumeric structure that is established in a seven-level hierarchical tree.
I
In Europe, medical material that fulfills the definition of a medical device according to the MDR (Medical Device Regulation) is classified into 4 classes
OC subscriptions: included in supply or field order tools (e.g. UniField)
SC subscriptions: included in supply or field tools
OC validations: approved for procurement and use by an OC for international or local orders specifying context and activity in Medical Standard Lists (MSL)

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RESPIRATOR

Definition

Personal Protective Equipment (PPE) for medical use

Filtering device covering nose, mouth and chin, used to protect the wearer against airborne or droplets transmitted infectious agents.

Filtering half mask: the facepiece consists entirely or substantially of filter material or comprises a facepiece in which the main filter(s) form an inseparable part of the device.

Specifications

Tuberculosis programmes

In order to determine which model or size of respirator is more suitable for the wearers, a respirator fit-test-kit (ELINMAFT1--) should be ordered together with samples of all available respirators.

VHF contexts

The respirator must not touch the face of the person

The respirator must be compatible with the Hood for VHF: SPPEHOOD2--

  • First choice is the large duckbill design ELINMASP02L
  • Second choice is the 3-panel design ELINMASP03M
  • The other models are not appropriate for VHF / Ebola contexts
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Quality standards

  • EN 14683, 2019, Medical face masks - Requirements and test methods
  • ISO 22609, 2004, edition 1, (confirmed 2020) Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)

Quality Standards Comment

Meets the specifications of either one of the following PPE standards:

  • European standard FFP2 (EN 149+A1: 2009 "Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking")
  • American standard N95 (US NIOSH certification according: Respiratory Protective Devices, 42 CFR Part 84)

Most N95 respirators are manufactured for use in construction and other industrial type jobs that expose workers to dust and small particles. They are labeled "For occupational use.”

and cleared for medical use:

  • EN 14683: 2019: Surgical masks - Requirements and test methods
  • ISO 22609: 2004: Clothing for protection against infectious agents - Medical face masks - Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected) (confirmed in 2020)

N95 respirators that are cleared by FDA for use in health care settings are called Surgical N95 Respirators. The clearance of these respirators involves the evaluation of safety data from biocompatibility testing and performance testing from fluid resistance and flammability testing. In addition, the Surgical N95 Respirators are NIOSH-certified, which includes filtration efficiency and testing to demonstrate that the device meets the N95 respirator performance requirements.

  • ASTM F1862/F1862M-17: Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)

See differences between surgical masks and respirators

Technical specifications

  • Polypropelene, polyester, polyethylene, aluminium
  • Meets the requirements of FFP2 or N95 (FFP2 or N95 must be written on the respirator itself)
    • Filtration efficiency with 0.3 µm particles: > 95% (N95) or > 94% (FFP2)
    • Total Inward Leakage (TIL): <10% (N95) or <8% (FFP2)
    • Penetration of the filtering material < 6% (NaCl and paraffine at 95 l/min with particles of 0.6 µm)
  • Meets the requirements of type II R:
    • bacterial filtration efficiency (BFE) > or = 98%
    • differential pressure (breathability) < 60 Pa
    • splash resistance pressure > or = 120 mm Hg
  • Covers the nose, the mouth and the chin and providing a tight seal around the edge
  • Does not collapse against the mouth (WHO recommendation, PPE in case of risk of exposure to filovirus, 2016)
  • Strong elastic straps around the head The head harness shall be designed so that the respirator can be donned and removed easily. The head harness shall be adjustable or self-adjusting and shall be sufficiently robust to hold the particle filtering half mask firmly in position and can maintain the total inward leakage requirements for the device.
  • Without valve
  • Non sterile, for single use

Packaging & Labelling

Box of 20 to 50 units

The following information shall be clearly and durably marked on the smallest commercially available packaging

  • The appropriate class: FFP2
  • "NR" if the particle filtering half mask is limited to single shift use only
  • The number and year of publication of the European Standard
  • At least the year of end of shelf life.
  • Recommended conditions of storage (at least the temperature and humidity) or equivalent pictogram

The information supplied by the manufacturer

  • shall accompany every smallest commercial available package
  • shall contain all information necessary for trained and qualified persons on
    • application/limitations
    • the meaning of any color coding
    • checks prior to use
    • donning, fitting
    • use
    • storage
    • the meaning of any symbols/pictograms used

Instructions for use

Prior to first use, perform a FIT TEST

Use the qualitative FIT TEST KIT (see related articles below) to select the respirator model and size that best fits the wearer's face.

The test must be renewed:

  • at least once a year
  • when changing to a new model/size
  • in case of physical change of the face of the user

Everytime a respirator is put on, PERFORM A SEAL CHECK

Stand in front of a mirror and fully open the respirator

STEP 1: Cup the respirator in your hand with the nosepiece at your fingertips

STEP 2: Position the respirator under your chin with the nosepiece up in order to cover the chin, the mouth and the nose

STEP 3: Pull the top strap over your head resting it high at the back of your head. Pull the bottom strap over your head and position it around the neck below the ears

STEP 4: Mould the nosepiece (using two fingers of each hand), to the shape of your nose

STEP 5: Cover the respirator with both hands, being careful not to disturb the position of the respirator

  • Inhale deeply in order to create an air vacuum: if the seal is good, the respirator will cling to your face
  • Exhale sharply: if the seal is good, the respirator will slightly expand
  • Inhale and exhale several times: no leakage of air between the face and the respirator may be detected

If problems are met (the respirator does not collapse neither expand or if air leak is detected), adjust the respirator and retest the seal. In case the problems persist, replace the respirator and/or try another model or size. Once the respirator is correctly fitted, don't manipulate it any longer.

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Precautions for Use

  • Respect the expiry date, if only manufacturing date is mentioned on the package: discard if older than 5 years (make sure to have new stock in replacement first). If no dates can be found: check elasticity of the headband before putting on
  • Facial hair that lies along the sealing area of a respirator, such as beards, sideburns, or some mustaches, will interfere with respirators that rely on a tight facepiece seal to achieve maximum protection," per the post. "Facial hair is a common reason that someone cannot be fit tested. Per the CDC, face hair "should not cross under the respirator sealing surface"

Storage

  • Store between 5 and 40°C
  • In a dry and well-ventilated place
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