2. Approvals This product meets the requirements of the European Community Directive 89/686/EEC (Personal Protective Equipment Directive) and are thus CE marked. Certification under Article 10, EC Type-Examination and Article 11, EC quality control, has been issued for this product by BSI Product Services, Maylands Avenue, Hemel Hempstead, HP2 4SQ, UK (Notified Body number 0086). This product meets the requirements of the European Community Directive 93/42/EEC (Medical Devices Directive) and are thus CE marked. 3M has self-certified this product according to Annex VII as Class 1 devices. Product Range 3M™ VFlex™ 1802 / 1802S Health Care Respirator Applications This respirator is available in two sizes - to fit a broad range of faces. 1802 = standard size. 1802S = small size. This respirator is suitable for us e in concentrations of solid and non-volatile liquid particles up to the following limits: Model EN 14683 Type EN 149+A1 Classification Exhalation Valve Threshold Limit Value, TLV 1802 II FFP2 NR D Unvalved 12 1802S II FFP2 NR D Unvalved 12 Respiratory protection is only effective if it is correctly selected, fitted and worn throughout the time when the wearer is exposed to hazards. Storage and Transportation The 3M™ Vlex™ 1802 / 1802S Health Care Respirator has a shelf life of 5 years. End of shelf life is marked on the product packaging. Before initial use, always check that the product is within the stated shelf life (use by date). Product should be stored in clean, dry conditions within the temperature range: – 20°C to + 25°C with a maximum relative humidity of <80%. When storing or transporting this product use original packaging provided. Disposal Contaminated products should be disposed as hazardous waste in accordance with national regulations. Fitting Instructions See Figure 1. Before fitting device, ensure hands are clean. 1. Using both hands, place fingers on the top side and thumbs on the underside of noseclip. Bend slightly at centre of noseclip. 2. Unfold the respirator by pulling top and bottom panels open to form a cup shape. Straps should be held on the top panel. 3. Cup respirator in one hand with open side towards face. Hold respirator under chin, with noseclip up. 4. Locate one strap below the ears, then the other strap across the crown of the head. Straps must not be twisted. Adjust top and bottom panels for a comfortable fit, ensuring edges are not folded in and bottom panel is securely under the chin. Tabs on side of respirator (marked 'A' in Figure 1 step 2) may be used to comfortably adjust respirator. 5. Using both hands, mould noseclip to the shape of the nose to ensure a close fit and good seal. Pinching the noseclip using only one hand may result in less effective respirator performance. 6. The seal of the respirator on the face should be fit- checked before entering the workplace. Figure 1
1. 3M™ VFlex™ 1802 / 1802S Health Care Respirator Description The 3M™ Vlex™ 1802 / 1802S Health Care Respirator provides effective respiratory protection for use in medical environments where health care workers will be exposed to airborne dust particles, non-volatile liquid particles and bio- aerosols. This respirator limits the transmission of infective agents from staff to patients. • Tested to EN 14683:2005 “Surgical masks – Requirements and test methods” and EN 149:2001+A1:2009 “Respiratory protective devices – Filtering half masks to protect against particles – Requirements, testing, marking”. • CE approved to the Medical Device and Personal Protective Equipment Directives. • V-shaped pleats flex with mouth movement for easier talking and expand to help ease of breathing. • Embossed front panel helps the respirator to retain its shape. • Available in 2 sizes to fit a broad range of faces. • Flat-fold design provides convenient storage prior to use. • Even headband strap pressure improves comfort on the neck, face and head with a secure feel • Adjustable, imbedded metal detectable, noseclip helps provide a custom fit and secure seal. • 3M™ Advanced Electret Filter Material gives effective filtration with low breathing resistance for consistent high quality performance. Materials The following materials are used in the production of the 1802 / 1802S Health Care Respirator: • Straps Polyisoprene • Staples Steel • Nose Clip Aluminium • Filter Polypropylene This product does not contain components made from natural rubber latex. Maximum mass of product = 10g Standards EN 149:2001+A1:2009 This product meets the requirements of recently amended European Standard EN 149:2001 + A1:2009, filtering facepiece respirators for use against particles. It should be used to protect the wearer from solid and non-volatile liquid particles only. Products are classified by filtering efficiency and maximum total inward leakage performance (FFP1, FFP2 and FFP3), also by usability and clogging resistance. Performance tests in this standard include filter penetration; extended exposure (loading) test; flammability; breathing resistance and total inward leakage. Reusable products are also subjected to cleaning, storage and mandatory clogging resistance tests (clogging is optional for non reusable products). A full copy of EN 149:2001+A1:2009 can be purchased from your national standards body. Designations: R = Reusable NR = Non reusable (single shift use only) D = Meets the clogging resistance requirements EN 14683:2005 These products meets the requirements of European Standard EN 14683:2005, Surgical marks – requirements and test methods. It should be used to limit the transmission of infective agents exhaled by the wearer to the environment and patients. It also provides additional protection against the penetration of bodily fluids through the product. Products are classified by bacterial filter efficiency and fluid resistance. Performance tests in this stan dard include bacterial filter penetration; pressure drop and fluid resistance. According to clause 5.2.2 Breathability – if the product also provides respiratory protection the differential pressure requirements of this standard do not need to be met, provided that the requirements of the relevant PPE standard (in this case EN 149:2001+A1:2009 clause 7.16 Breathing Resistance) are met. A full copy of EN 14683:2005 can be purchased from your national standards body. Designations: I = Bacterial Filter Efficiency ≥ 95% II = Bacterial Filter Efficiency ≥ 98% R = Splash resistance pressure ≥ 120mmHg
3. Fit Check 1. Cover the front of the respirator with both hands being careful not to disturb the fit of the respirator. 2. UNVALVED respirator - EXHALE sharply; 3. If air leaks around the nose, re-adjust the noseclip to eliminate leakage. Repeat the above fit check. 4. If air leaks at the respirator edges, work the straps back along the sides of the head to eliminate leakage. Repeat the above fit check. If you CANNOT achieve a pr oper fit DO NOT enter the hazardous area. See your supervisor. Users should be fit tested in accordance with national requirements. For information regarding fit testing procedures, please contact 3M. Warnings and Use Limitations • Always be sure that the complete product is: - Suitable for the application; - Fitted correctly; - Worn during all periods of exposure; - Replaced when necessary. • Proper selection, training, use and appropriate maintenance are essential in order for the product to help protect the wearer from certain airborne contaminants. • Failure to follow all instructions on the use of these respiratory protection products and/or failure to properly wear the complete product during all periods of exposure may adversely affect the wearer’s health, lead to severe or life threatening illness or permanent disability. • For suitability and proper use follow local regulations and refer to all information supplied. For more information contact a safety professional/3M representative. • Before use, the wearer must be trained in use of the complete product in accordance with applicable Health and Safety standards/guidance. • These products do not contain components made from natural rubber latex. • These products do not protect against gases/vapours such as glutaraldehyde. • Do not use in atmospheres containing less than 19.5% oxygen. (3M definition. Individual countries may apply their own limits on oxygen deficiency. Seek advice if in doubt). • Do not use for respiratory protection against atmospheric contaminants/concentrations which are unknown or immediately dangerous to life and health (IDLH). • Do not use with beards or other facial hair that may inhibit contact between the face and the product thus preventing a good seal. • This product does not eliminate the risk of contracting any disease or infection. • Leave the contaminated area immediately if: a) Breathing becomes difficult. b) Dizziness or other distress occurs. c) The respirator becomes damaged d) You taste or smell contaminants, or an irritation occurs • Discard and replace the respirator if it becomes contaminated with blood or other infectious material, damaged, breathing resistance becomes excessive or at the end of a shift. • Never alter, modify or repair this device. • In case of intended use in explosive atmospheres, contact 3M. Single use only. Do not reuse. Important Notice 3M does not accept liability of any kind, be it direct or cons equential (including, but not limited to, loss of profits, busine ss and/or goodwill) arising from reliance upon any information herein provided by 3M. The user is responsible for determining the suitability of th e products for their intended use. Nothing in this statement w ill be deemed to exclude or restrict 3M’s liability for death or personal injury arising from its negligence. 3M Occupational Health & Safety Division EMEA Region 3M Centre Cain Road Bracknell Berkshire RG12 8HT United Kingdom Tel: + 44 (0) 1344 858000 Web: www.3M.eu/Safety Please recycle. © 3M 2010. All rights reserved. Issued: May 2011
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