tel.: +48 42 215 10 68
fax: +48 48 203 20 31
95-200 Pabianice,
ul.Piłsudskiego 23
E-mail adress:
oxyline@oxyline.eu
Filter respirator
Filter respirator cup shaped Oxyline

Filtering half mask: X 310 FFP3 NR

Description
PRODUCT CODE: X310FFP3NR

The half mask respirator X 310 FFP3 NR half mask is a non-sterile single-use medical product, type II R. It complies with the requirements of EN 14683:2019 with a limited duration of use, up to a maximum of 8 hours. It has a bacterial filtration efficiency (BFE) of ≥ 98.0 %. The respirator is approved for use in medical environments where there is a risk of splashing bodily fluids.

PURPOSE:
The half mask respirator X 310 FFP3 NR
is intended for protection in places exposed to infectious and infectious materials where there is a risk of splashing of body fluids. It is used to cover the mouth, nose and chin. The product constitutes a barrier limiting the transmission of an infectious agent and protecting the respiratory tract. It prevents the spread of airborne microorganisms, reducing the risk of infection by medical personnel. Its use ensures sterile treatment conditions and protects the patient from viruses/bacteria e.g. during medical procedures.

The half mask respirator X 310 FFP3 NR half mask is also intended for use by medical personnel and patients in the event of exposure to blood and other potentially infectious body fluids.
It is also designed to protect respiratory system against solid particles aerosols, water-based aerosols (dust, smoke) and aerosols with liquid dispersed phase (mist). for which the TLV is ≤0,05 mg/m3 as long as the dispersed phase concentration does not exceed 30 x TLV. Protection against non-toxic, moderately or highly toxic liquid or solid particles (e.g. oil mists) at concentrations up to 30 × OEL (APF = 30. NPF = 50).
NOTES:
OEL = Occupational Exposure Limit.
APF = Assigned Protection Factor.
NPF = Nominal Protection Factor.

EXAMPLES OF USE:
Half-masks can be used in environment with high concentration of respirable dust. It can be used in the following industries: metallurgy, foundry, welding and soldering. It protects against dusts containing: beryllium, lead, antimony, arsenic, cadmium, cobalt, nickel, radium, strychnine, radioactive particles. It can be used to work with asbestos.
It is also used in the chemical, glass, optical, electronics, construction and pharmaceutical industries.

The World Health Organization (WHO) recommends the use of class FFP3 respirators for preventive protection against viruses, bacteria and other microorganisms, for workers in the medical and pharmaceutical sectors, (hospitals, pharmacies, laboratories, clinics) and for the prevention of the spread of pandemics and protection of the population (public transport, aviation).

DESCRIPTION:
The half mask respirator X 310 FFP3 NR
filtering half mask is composed of the following elements:
• A multi-layered filtration material: polypropylene
• A nose clip to shape the half mask at the nose;
• Plastic fastenings of the head bands;
• Nose seal made of polyurethane foam
• Internal lining improving tightness and comfort of use.

The half mask is designed in such a way as to enable easy breathing throughout the work shift. The anatomical shape and the nose clip, as well as the internal sealing foam, make the half mask easy to fit to most face shapes, so that the necessary tightness can be ensured.

REQUIREMENTS:
Half mask respirators X 310 FFP3 NR
respirators comply with Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical products, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance).
Half mask respirators X 310 FFP3 NR respirators have been designed and placed on the market in accordance with the Regulation of the European Parliament and Council (EU) 2016/425 of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC.

EN 14683:2019 + AC:2019 - Medical face masks – requirements and test methods
EN ISO 15223-1:2016 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied - Part 1: General requirements
EN 1041:2008+A1:2013 - Information supplied by the manufacturer of medical devices
EN ISO 14971:2019 - Medical devices — Application of risk management to medical devices
EN 149:2001 + A1:2009 - Respiratory protective devices -- Filtering half masks for protection against particles - Requirements, testing, marking

Requirements with regard to the user's health harmlessness of the materials used, which is confirmed by a positive opinion of the Institute of Occupational Medicine in Lodz.

Downloads
Instruction - instrukcja półmasek Instruction Download
Declaration of Conformity - X310FFP3NR Declaration of Conformity Download
Data sheet - X310FFP3NR Data sheet Download
quanmedia