Surgical mask or Respirator

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1 Surgical mask or Respirator What is a surgical mask? A surgical mask is loose-fitting, disposable mask that covers the nose and mouth. These include products labeled as surgical, dental, medical procedure, isolation, and laser masks. Facemasks help stop droplets from being spread by the person wearing them. They also keep splashes or sprays from reaching the mouth and nose of the person wearing the facemask. They are not designed to protect you against breathing in very small particles. Facemasks should be used once and then thrown away in the trash. What is a respirator? A respirator is designed to protect you from breathing in very small particles, which might contain viruses. These types of respirators fit tightly to the face so that most air is inhaled through the filter material. To work the best way, respirators must be specially fitted for each person who wears one (this is called "fit-testing" and is usually done in a workplace where respirators are used). Some healthcare workers, such as nurses and doctors, use these types of respirators when taking care of patients with diseases that can be spread through the air. What you should know about using surgical masks and respirators? European Standard 1. EN (Surgical masks - Requirements and test methods) Introduction: The transmission of infective agents during surgical procedures in operating theatres and other medical settings, can occur in several ways. Sources are e.g. noses and mouths of the surgical team. The main intended use of surgical masks is to protect the patients from infective agents from the noses and mouths of the staff and, in certain situations, to protect the wearer against splashes of potentially contaminated liquids.

2 Scope: This European Standard specifies construction and performance requirements, and test methods for surgical masks intended to limit the transmission of infective agents from staff to patients and (in certain situations viceversa) during surgical procedures in operating theatres and other medical settings with similar requirements. This European Standard is not applicable to masks intended exclusively for the personal protection of staff. Classification: Surgical masks specified in this standard are classified into two types according to bacterial filtration efficiency and differential pressure and each type is further divided according to whether or not the masks are splash resistant. Performance requirements for surgical masks: Test Type I Type IR Type II Type IIR Bacterial Filtration Efficiency (BFE), (%) Differential pressure (mm water /cm² ) < 3 < 5 <3 <5 Splash Resistance pressure (mm Hg) Not required 120 Not required 120 NOTE: Type IR and Type IIR are splash resistant types. Labelling and information have to be supplied: Annex 1 13 of the Medical Devices Directive (93/42/EEC) specifies the information that has to be specified on the packaging in which the surgical mask is supplied. The following information shall be supplied: a) The number of this European Standard. b) The type of mask (as indicated in Table). 2. EN 149 (European Standards for disposable filtering face piece respirators) Scope: This European Standard specifies construction and performance requirements, and test methods for Filtering Face Piece Respirators to protect against solid aerosols, or oil based particulates. Classification: EN 149 divides particulate protection into the following categories: FFP1, FFP2, FFP3

3 Performance requirements for Filtering Face Piece Respirators: Requirements Type Penetration of filter media Breathing resistance (mbar) Sodium chloride 95 l/min Paraffin oil 95 l/min Inhalation Exhalation 30 l/min 95 l/min 160 l/min FFP1 20% 20% 0,6 2,1 3 FFP2 6% 6% 0,7 2,4 3 FFP3 1% 1% Labelling and information have to be supplied: The following information shall be supplied: a) Identification of the manufacturer or responsible supplier. b) Protection class: FFP1, FFP2 or FFP3. c) Number of the standard and year of publication (EN 149:2001) d) Year of the end of the storage time. e) Recommended storage conditions. f) Instructions for use shall be given with every smallest commercial package. g) Identification number on the body which has made the EC-type examination. Which case? Which mask? View of the requirements: Personal Protective Equipment Directive Filtering Face Piece (EN149) Personal Protective Equipment US Norm N95 Medical Devices Directive Surgical mask (EN 14683) Filtering efficiency Sodium chloride Filtering efficiency Sodium chloride Bacterial filtration efficiency (staphylococcus aureus) Filtering efficiency Paraffin oil - - Total inward leakage Total inward leakage - Breathing resistance Breathing resistance Breathing resistance Rebreathed CO Fluid penetration No bacterial filtration efficiency No bacterial filtration efficiency No Filtering efficiency against Paraffin oil Surgical masks are not Personal Protective Equipment. Most requirements of EN149 not tested Inhalation protection is not considered

4 Normal surgical masks are not certified as protective against airborne diseases. Surgical masks are not designed for use as particulate respirators and do not provide as much protection as a respirator. Surgical masks do not prevent leakage around the edge of the mask the user inhales. About 60% - 90% particulates pass through the edge the mask. when of Devices should comply with the Directive(s) that covers the principle intended purpose of the device. 1. Protecting the patient: Medical Devices Directive 2. Protecting the wearer: Personal Protective Equipment Directive 3. In certain situations, to protect the wearer against splashes liquids: Medical Devices Directive Wearing DACH-High-Risk-Mask as protective against airborne diseases DACH-High-Risk-Mask is a respirator especially for medical use. DACH-High-Risk-Mask is Personal Protective Equipment, accredited in reference to EN149:2001 FFP3, especially for medical use. DACH-High-Risk-Mask has very high Filtration Efficiency (99,47%) and an extremely low Breathing resistance (even lower than an FFP1 respirator). Test results EN 149 Requirements DACH-High-Risk-Mask FFP3 FFP1 FFP2 Penetration of filter media (Sodium chloride) 20% 6% 1% 0,53% Breathing resistance (mbar) Inhalation (30 l/min) 0,6 0,7 1 0,26 Inhalation (95 l/min) 2,1 2,4 3 0,88 Exhalation (160 l/min) ,37 The DACH-High-Risk-Mask obtained best results in a test arranged by a German government safety organization.

5 About using a respirator. You must wear the respirator correctly. You will not be protected if you don't wear your respirator correctly. Follow the manufacturer's instructions. Check before use: Inspect the respirator if there are any deficiencies. 1. Check the face-piece for cuts, tears, frays or loss of elasticity. 2. Check for damaged or missing hardware. 3. Check the elasticity of the headbands. Don a respirator 1. Cup the respirator in your hand with the nosepiece at your fingertips. Slightly bend the nose piece to form a gentle curve. 2. Position the respirator over your nose and mouth with the nosepiece up. Pull the bottom strap over your head and position it around neck below your ears. 3. Pull the top strap over your head so it rests high on the back of your head. 4. Using two hands, mould the nosepiece to the shape of your nose. Press the nose piece tightly on your nose. 5. Adjust the respirator tightly on your face. Nothing (beards, head coverings, etc.) passes between the skin and the respirator's sealing edge. The respirator cannot be used with beards, facial hair, or other conditions that prevent a good seal between the face and the edge of the respirator. Removing a respirator if 1. Significant increase in the amount of breathing resistance. 2. The respirator collapses due to excess moisture. 3. The employee senses (smells/tastes) breakthrough. 4. The respirator is visibly soiled or damaged. 5. The respirator no longer seals to the user s face. 6. Upon leaving the patient s room (followed by hand hygiene).

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