3M VFlex Manual Del Usuario página 4

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These products meet the requirements of EN149:2001+A1:2009, filtering facepiece respirators for
use against particles. These products should be used to help protect the wearer from certain solid
and non-volatile liquid particles according to their performance classification: FFP2 up to 10 x WEL.
WEL - Workplace Exposure Limit. These products meet the requirements of EN 14683:2019 Type II,
Medical face masks for use to limit the transmission of infective agents from staff to patients. These
products are intended for professional healthcare workers.
Particular attention should be given to warning statements where indicated.
^ WARNINGS AND 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 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.
• Please report any serious incident occurring in relation to the device to 3M and the local competent
authority (EU) or local regulatory authority.
• Discard and replace the respirator if it becomes contaminated with blood or other infectious
material, damaged, breathing resistance becomes excessive, at the end of a shift, or in accordance
with your organisation's infection control policy.
• Filtering face piece respirators are for single use only. Reuse of these respirators may cause
cross-contamination, compromise user safety and overall product performance.
• Contaminated products should be disposed as hazardous waste in accordance with national
regulations.
• Do not alter, modify, clean or repair this respirator.
• In case of intended use in explosive atmospheres, contact 3M.
• Before initial use, always check that the product is within the stated shelf life (use by date).
FITTING INSTRUCTIONS
1802 is suggested for the majority of users. 1802S is suggested for users with small faces.
See Figure 1. Before fitting device, ensure hands are clean.
All respirator components should be inspected for damage prior to each use. 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. Take
both straps in other hand. Hold respirator under chin, with nosepiece up, and pull straps over head.
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.
FIT CHECK
1. Cover the front of the respirator with both hands being careful not to disturb the fit of the respirator.
2a) UNVALVED respirator - EXHALE sharply; 2b) VALVED respirator - INHALE 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 proper 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.
STORAGE AND TRANSPORTATION
Store in accordance with manufacturer's instructions, see packaging.
NOTE: Average conditions may exceed 25°C / 80% RH for limited periods. They can reach an
average of 38°C / 85% RH, provided that this is for no more than 3 months in the shelf life of the
product. When storing or transporting this product use original packaging provided. Do not store in
direct sunlight.
MARKING / GLOSSARY TABLE
Symbol Title Symbol Description and Reference
CE mark Indicates conformity to all applicable European Union
XXXX
Regulations and Directives with notified body involvement.
Classification FFPX NR D Indicates product classification. Source: EN 149
(X = 1, 2 or 3)
3M EU Address Indicates postal address as defined in PPE Regulation (EU)
3M Deutschland GmbH,
Carl-Schurz-Str.1,
2016/425.
41453 Neuss, Germany
Manufacturer Indicates the medical device manufacturer as defined in EU
Directives 90/385/EEC, 93/42/EEC and 98/79/EC Source: ISO
15223, 5.1.1
Authorised Indicates the authorized representative in the European
!
Representative in Community. Source: ISO 15223, 5.1.2, 2014/35/EU and/or
European 2014/30/EU
Community
Importer Indicates the entity importing the medcial device into the EU.
T
Medical Device Indicates the item is a medical device.
V
Catalogue Number Indicates the manufacturer's catalogue number so that the
<
medical device can be identified. Source : ISO 15223, 5.1.6
Sizing S Indicates small size
Lot Number / Indicates the manufacturer's batch code/lot number so that the
>
Batch code batch or lot can be identified. Source : ISO 15223, 5.1.5
End of Shelf Life / Indicates the date after which the medical device is not to be
)
Use-By Date used. Source: ISO 15223, 5.1.4
Temperature Range / Indicates the temperature limits to which the medical device
\
Temperature Limit can be safely exposed. Source: ISO 15223, 5.3.7
Maximum Relative Indicates a medical device that needs to be protected from
,
Humidity / Keep Dry moisture. Source: ISO 15223, 5.3.4
Unique Device Indicates bar code to scan product information into patient
W
Identifier electronic health record.
Caution / Indicates the need for the user to consult the instructions for
Z
Consult instructions use for important cautionary information such as warnings and
for use precautions that cannot, for a variety of reasons, be presented
on the medical device itself. Source: ISO 15223, 5.4.3 and ISO
15223, 5.4.4
Natural Rubber Indicates natural rubber or dry natural rubber latex is not
X
Latex is not present present as a material of construction within the medical device
or the packaging of a medical device. Source: ISO 15223,
5.4.5 andAnnex B
Do Not Re-use Indicates a medical device that is intended for one use or for
)
use on a single patient during a single procedure. Source: ISO
15223, 5.4.2
Green Dot Indicates a financial contribution to national packaging
recovery company per European Directive No. 94/62 and
corresponding national law. Packaging Recovery Organization
Europe.
For more information, see HCBGregulatory.3M.com
APPROVALS
As personal protective equipment these products are type approved and audited annually by either:
BSI Group, The Netherlands B.V. Say Building, John M. Keynesplein 9, 1066 EPAmsterdam, The
Netherlands, Notified Body No. 2797 and / or BSIAssurance UK Ltd, Kitemark Court, DavyAvenue,
Knowlhill, Milton Keynes MK5 8PP, UK, Notified Body No. 0086. These products meet the
requirements of European Regulation (EU) 2016/425 and applicable local legislation. The applicable
European/local legislation and Notified Body can be determined by reviewing the Certificate(s) and
Declaration(s) of Conformity at www.3m.com/Respiratory/certs.
As medical devices, these products meet the requirements ofAnnex VII of the European Community
Directive 93/42/EEC orAnnex IV of the European Regulation (EU) 2017/745 as Class 1 devices.
Issue Date:04-2020
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