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               Face-Piece Respirator 

DOC. No. : WI-RD-24

 

 

Page  3  / 8 

Rev.: 2 

Date: May 13, 2020 

 

 

© 

ROYAX-

Obchodni 107, 251 01 Cestlice, Czech Republic  May 2020

 

 
T/F: +420 321 123 111/2     +971 43549635/267 
 

www.royax.eu

          [email protected] 

1.

 

DESCRIPTION 

Royax high quality and performance respirators which designed and manufactured in 

accordance with to the EN 149:2001+A1:2009 st RfU02.075 rev. 1 of the notified 
Bodies VG2 against COVID-19 work using the electrostatics to attract and then to trap the tiniest 

of existing particles. 

Our respirator is designed to protect against living organisms such as viruses, bacteria, 

fungi and also fine dust, fibers, aqueous mists, oil-based mists.  

Microorganisms (viruses, bacteria, fungi) can be transmitted by various routes.  

Respiratory protection is needed to prevent infection with organisms that are usually entered the 

body through inhalation (droplet/airborne). The respirator should be used together with other 
PPE for health care professional.  

The  respirator  is  recommended  for  health  care  protection  (HPC)  in  contact  with  a  

confirmed  or  suspected  case  of  Covid-19.  Also,  respiratory  protection  is  crucial  to  

reduce  risk  of  airborne  infections  spreading  when  the  people  cough,  sneeze  or  
speak.  

Our product (respirator) are fitting to the face are meant to make a seal. Adjustable nose 

clip to prevent leakage and provide comfort.  

The respirator must be put on and removed in an order that minimizes the potential for cross 
contamination.    Failure  to  follow  all  instructions  and  limitations  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 sickness or death  

 The respirators consist of a 4-layers` construction (please refer to the 1.1. Article of this 

IFU), comprising two layers of high-quality spun bond material with smooth surface finish which 
covers two layers of outstanding performance melt blown filter material that is electrostatically 

charged.  The  electrostatic  element  attracts  and  then  traps  the  tiniest  of  particulate  whilst 
remaining easy to breathe through. The non-valve construction ensures that the wearer does not 

exhale potentially harmful organisms to others nearby. 
To be fully effective, the respirator must be put on and removed in a routine that minimizes the 

potential for cross contamination. 

1.1

 

Component parts of the Respirator 

 
          

 
 

 

 

 

 

 

 

 

 

Summary of Contents for R-DP-R-FFP2-01

Page 1: ...User s Manual Filtering Face Piece Respirator Catalog code R DP R FFP2 01 ROYAX S R O ...

Page 2: ... for the proper use of this product prior to use and after use This manual does not provide any medical advice or instruction Proprietary rights The information revealed in this manual is the property of ROYAX hereinafter referred such Manufacturer Czech Republic ROYAX reserves design and manufacturing rights of this product Conservation of the manual This manual must be kept together with the pro...

Page 3: ...nfo royax eu Contents 1 DESCRIPTION 3 1 1 Component parts of the respirator 3 1 2 Respirator s fitting instructions 4 1 3 Respirator s removal 4 1 4 Warnings 4 1 5 Notified body s information 5 2 CLEANING DISINFECTION MAINTENANCE and TRANSPORT 5 2 1 Cleaning and disinfection 5 2 2 Maintenance 5 2 3 Transport 5 3 SYMBOLS AND OTHER NECESSARY INFORMATION 6 3 1 Validity 6 3 2 Symbols 6 ...

Page 4: ...espiratory protection is crucial to reduce risk of airborne infections spreading when the people cough sneeze or speak Our product respirator are fitting to the face are meant to make a seal Adjustable nose clip to prevent leakage and provide comfort The respirator must be put on and removed in an order that minimizes the potential for cross contamination Failure to follow all instructions and lim...

Page 5: ...espirator removal After use respirators may become contaminated and should not be touched and if touched the hands must be washed immediately and thoroughly Removal and disposal have to be performed very carefully because they may become themselves a source of an infection Instructions of removal Pull the ear loop from behind one ear and then the other Hold the respirator by ear loop Immediately d...

Page 6: ...pirator with a new one as soon as it becomes damps or humid Do not use in explosive atmosphere Store respirator away from contaminated areas when not in use Dispose of used product in accordance with applicable regulations of your country 1 5 Notified body s information Notified Body for module B C2 MTIC InterCert s r l Via Moscova 11 20017 RHO MI ITALY Notified Body number 0068 2 CLEANING DISINFE...

Page 7: ...ate shown on the package Explanation of markings on the product and packing PPE R 02 075 version 1 personal protection equipment Commission Recommendation EU 3 2 Symbols Temperature 20 C to 30 C Humidity Max 80 YYYY MM year month End of shelf life Single use mask 5 Pcs High Quality reference number for identifying product product lot number for product traceability production date End of shelf lif...

Page 8: ...7 www royax eu info royax eu right direction to storage Maximum moisture keep away from consult with the allowed for storage sunlight instruction for use and infor mation supplied by the producer Do not put more than keep away from fire storage temperature Carry by Limit 5 boxes on top of hand each other reference number for identifying product product is stackable ...

Page 9: ...ents of Annex I of the European Community Council Regulation 2016 425 ROYAX s r o further declares that the product complies with the relevant provisions of Regulation 2016 425 concerning personel protection equipment and in particular the conformity of the product with the Essential Requirements in Annex II of the Regulation and is the subject of the EU Type Examination Certificate issued by MTIC...

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