ROYAX R-DP-R-FFP2-01 User manual

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

Face-Piece Respirator
DOC. No. : WI-RD-24
Page 1 / 8
Rev.: 2
Date: May 13, 2020
© ROYAX-Obchodni 107, 251 01 Cestlice, Czech Republic May 2020
T/F: [phone]/2 [phone]/267
www.royax.eu [e-mail]
Thank you for choosing a ROYAX product
This manual is intended to provide necessary information needed for using
Face-piece Respirator (hereinafter referred to as “Product” or “Respirator”)
Disclaimer: All applicable instructions on the usage of the product and safety
precautions are integrated in this document. ROYAX takes no responsibility for
damages caused by the improper use of the product. It is highly recommended
that users follow all these instructions 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 product
for the life of the product.
Disposal of the product: Removal and disposal have to be performed very
carefully, because they may become themselves a source of an infection. Please
follow the instructions set forth in this IFU.
ROYAX: Obchodni 107, 251 01, Cestlice, Czech Republic
T/F: [phone]/2
www.royax.eu
[email protected]
Legislation:
EN149:2001 + A1:2009 partly applied
RfU02.075 revision 1 of the notified Bodies VG2 against COVID-19
PPE (EU) 2016/425

Face-Piece Respirator
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Rev.: 2
Date: May 13, 2020
© ROYAX-Obchodni 107, 251 01 Cestlice, Czech Republic May 2020
T/F: [phone]/2 [phone]/267
www.royax.eu [e-mail]
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
1.4Warnings .................................................................................................................... 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

Face-Piece Respirator
DOC. No. : WI-RD-24
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Rev.: 2
Date: May 13, 2020
© ROYAX-Obchodni 107, 251 01 Cestlice, Czech Republic May 2020
T/F: [phone]/2 [phone]/267
www.royax.eu [e-mail]
1. DESCRIPTION
Royax high quality and performance respirators which designed and manufactured in
accordance with to the EN 149:2001+A1:2009 standard + 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

Face-Piece Respirator
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Rev.: 2
Date: May 13, 2020
© ROYAX-Obchodni 107, 251 01 Cestlice, Czech Republic May 2020
T/F: [phone]/2 [phone]/267
www.royax.eu [e-mail]
1.2. Respirator`s fitting instructions:
1) Hold the mask as shown, with the nose piece at the fingertips
2) Raise the mask to face, placing so that the nose and mouth are covered.
3) Secure the mask by pulling the straps behind each ear.
4) Gently pinch the nose piece to adjust the fit comfortably and neatly across the nose and
around the face.
5) Use both hands to hold the front of the respirator and check
for air leakage around the mouth and nose.These should be close-fitting.
1.3. Respirator 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 discard in proper container.
•Hand hygiene should be performed after removal and disposal respirator.
1.4. Warnings:
•If the respecter is damaged or if it becomes contaminated with respiratory
secretions or other body fluids, it should be changed and dispose of as a health care waste.
•Leave contaminated area immediately and contact supervisor if you smell or
taste contaminants or if dizziness, irritation, or other distress occurs.
•Do not use if the respirator is extremely crumpled.

Face-Piece Respirator
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Rev.: 2
Date: May 13, 2020
© ROYAX-Obchodni 107, 251 01 Cestlice, Czech Republic May 2020
T/F: [phone]/2 [phone]/267
www.royax.eu [e-mail]
•Do not use with beards or other facial hair or other conditions that prevent a
well seal between your face and the face seal of the respirator.
•Do not use in oxygen deficient atmospheres less than 19.5% by volume at sea
level.
•Do not use in poorly ventilated areas.
•Do not use for firefighting and sandblasting.
•Washing with alcohol, water and detergent will damage the respirator
irreversibly.
•Autoclaving and other forms of heating also damage the respirator.
•Reuse is forbidden.
•The respirator shall not be used for more than one shift.
•Do not touch the front of the respirator when you remove it.
•Replace respirator 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, DISINFECTION, MAINTENANCE and TRANSPORT
2.1. Cleaning and Disinfection:
Washing with alcohol, water and detergent will damage the respirator irreversibly.
2.2. Maintenance:
The life of the respirator depends on the time of use, care and maintenance. Before use, do a
thorough inspection of the product. If any part of the product is damaged, replace the entire
product immediately. We recommend that mask is kept in a suitable case or pack when not in
use. In every case, the product must be replaced after a period of one shift (8 hours).
2.3. Transport:
The protector must be transported in it`s original packing (nylon bag).

Face-Piece Respirator
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Rev.: 2
Date: May 13, 2020
© ROYAX-Obchodni 107, 251 01 Cestlice, Czech Republic May 2020
T/F: [phone]/2 [phone]/267
www.royax.eu [e-mail]
3. SYMBOLS AND OTHER NECESSARY INFORMATION
3.1. Validity:
The product is with a validity of 5 years after the manufacturing date 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°CHumidity :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 life
see information supplied by manufacturer
minimum and maximum storage temperature
Maximum moisture allowed for storage

Face-Piece Respirator
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Rev.: 2
Date: May 13, 2020
© ROYAX-Obchodni 107, 251 01 Cestlice, Czech Republic May 2020
T/F: [phone]/2 [phone]/267
www.royax.eu [e-mail]
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

Face-Piece Respirator
DOC. No. : WI-RD-24
Page 8 / 8
Rev.: 2
Date: May 13, 2020
© ROYAX-Obchodni 107, 251 01 Cestlice, Czech Republic May 2020
T/F: [phone]/2 [phone]/267
www.royax.eu [e-mail]
EU DECLARATION OF CONFORMITY
No. 20200501/1
According to Directive PPE (EU) 2016/425
Manufacturer:
ROYAX, s.r.o.
Address:
Obchodni 107, Cestlice, 251 01, Czech Republic
Name of Device:
Respirator face mask
Device Types` Codes:
R-DP-R-FFP2-01
Category of Device: III
According to Annex I RISK CATEGORIES OF PPE
(Classification) of the EU Community Council
Directive (EU) 2016/425.
Notified Body
MTIC InterCert s.r.l
Via Moscova,11-20017 RHO(MI)-ITALY
Notified Body number
0068
ROYAX, s.r.o. hereby under its sole responsibility declares that the above specified personal
protective equipment has been determined as the Category III device according to the requirements
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 Intercert S.r.l.
The product has been designed, developed, manufactured and tested in accordance with
all applicable standards and by using a quality management system according to EN ISO
13485:2016.
Standards Applied:
EN149:2001 + A1:2009 Partly applied with RfU02.075rev1 COVID-19 Specific Respiratory
protective devices - Filtering half masks to protect against particles - Requirements, testing,
marking and quality control procedures for the final product according to Module C2 of the PPE
Regulation 2016/425
under the supervision of MTIC Intercert S.r.l. (notified Body number 0068)
Prague
ROYAX s.r.o.
NAME: Rambod Afrashteh
Position :CEO
SIGNATURE: